Lynch SyndromeLynch syndromeNCT07445828
Evaluation of Capsule Colonoscopy in Patients With Lynch Syndrome
An observational study of Lynch Syndrome, run by Region Skane at 1 site in Sweden.
Trial summary
Lynch syndrome is the most common hereditary cancer syndrome and is caused by pathogenic variants in DNA mismatch repair genes, resulting in a markedly increased lifetime risk of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- colon capsule endoscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteSweden
- Study dates
- May 2026to 31 Dec 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consists of adults aged 18-60 years with genetically confirmed Lynch syndrome who are referred for guideline-based surveillance colonoscopy at Skåne University Hospital, Malmö. Eligible participants are identified by referring physicians at the endoscopy unit or gastroenterology outpatient clinic. Consecutive patients who meet the inclusion criteria and have no contraindications to colon capsule endoscopy or study participation are invited to enroll. Participants undergo both non-invasive colon capsule endoscopy and conventional colonoscopy according to the study protocol. Written informed consent is obtained by a study physician prior to any study-related procedures and documented in the medical record. Participation is voluntary, and participants may withdraw at any time without impact on future medical care. A total of 80 consecutive patients will be enrolled. The study evaluates the diagnostic performance and safety of colon capsule endoscopy as a first-line
Who may be able to join
- Genetically confirmed Lynch syndrome with a planned surveillance colonoscopy according to guideline-based recommendations
- Age 18-60 years
- Written informed consent obtained
Who cannot join
- Need for an translator
- Known history of gastroparesis or intestinal pseudo-obstruction
- Known or suspected stricture or stenosis of the gastrointestinal tract
- Previous small bowel or colonic resection
- Dysphagia or swallowing difficulties
- Severe debilitating disease
- Allergy or contraindication to any medications or products used in the study
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Skane University Hospital Malmö
Malmö, Skåne County, 20502
Gabriele Wurm Johansson, Docent, +46 40 338622, gabriele.wurmjohansson@skane.se
About this study
Lynch syndrome is the most common hereditary cancer syndrome and is caused by pathogenic variants in DNA mismatch repair genes, resulting in a markedly increased lifetime risk of colorectal cancer. The estimated lifetime risk of colorectal cancer varies by the affected gene and is approximately 54-74% in men and 30-52% in women with Lynch syndrome. Colorectal cancer in this population is typically diagnosed at a younger age than in the general population. Current national guidelines recommend colonoscopic surveillance every one to two years beginning at 20-25 years of age to reduce colorectal cancer risk. However, individualized modification of surveillance strategies is under active consideration based on factors such as the specific mutated gene, family history of cancer, smoking status, prior malignancies, and age at surveillance initiation.
Conventional colonoscopy, the current standard method for colorectal evaluation, may cause substantial discomfort or anxiety, leading some patients to decline participation. Colonoscopy is also resource intensive, and procedural capacity is limited. Previously reported limitations in colonoscopy resources and quality in Sweden highlight the need to evaluate alternative surveillance and screening approaches.
Read more
Colon capsule endoscopy (CCE) has been available for clinical use since 2006 as a non-invasive alternative to colonoscopy, enabling endoscopic visualization of the entire colon. The system consists of a single-use, swallowable capsule containing miniature cameras that capture images as the capsule progresses through the gastrointestinal tract via natural peristalsis. Images are transmitted wirelessly to a portable data recorder worn by the patient and subsequently reviewed using dedicated software.
CCE offers several advantages compared with conventional colonoscopy and CT colonography, including no requirement for sedation, endoscope insertion, gas insufflation, or ionizing radiation. The examination and image acquisition can be performed outside the hospital setting. This patient-centered approach has the potential to improve adherence to repeated examinations and long-term surveillance programs, which is particularly important for individuals with hereditary colorectal cancer syndromes. CCE may also reduce demands on healthcare resources.
International guidelines indicate that the mucosal diagnostic performance of CCE is comparable to that of standard colonoscopy and that the method is appropriate for screening purposes. Adequate bowel preparation is required for both colonoscopy and CCE. Unlike conventional colonoscopy, bowel cleansing cannot be optimized during CCE, and the procedure is limited by capsule battery life, typically 10-12 hours. To maintain bowel cleanliness and facilitate capsule transit, patients administer laxative and prokinetic agents at predefined time points during the examination.
The primary objective of this study is to evaluate the diagnostic performance and safety of colon capsule endoscopy as a first-line surveillance modality in patients with Lynch syndrome and to assess patient experience and acceptance of CCE compared with conventional colonoscopy.
Read the detailed description
Detailed Description
Study Overview This is a pragmatic, prospective, observational study designed to compare colon capsule endoscopy (CCE) with conventional colonoscopy in individuals with genetically confirmed Lynch syndrome. The study is conducted within an established colorectal cancer surveillance program and reflects routine clinical practice.
Study Objectives The primary objective of the study is to evaluate the diagnostic performance and safety of colon capsule endoscopy when used as a first-line surveillance examination in patients with genetically confirmed Lynch syndrome. Secondary objectives include assessment of patient-reported experience, acceptability, and preference for colon capsule endoscopy compared with conventional colonoscopy, assuming equivalent diagnostic performance.
Study Design and Procedures Participants undergo both colon capsule endoscopy and conventional colonoscopy using a paired, same-day, blinded design. Colon capsule endoscopy is performed using a standardized bowel preparation protocol. The capsule examination is interpreted by an experienced specialist physician.
Conventional colonoscopy, representing standard of care, is scheduled after confirmed capsule excretion on the same day without additional bowel preparation, or, if necessary, on the morning following the capsule examination. Sedation is offered according to local clinical practice. The endoscopist performing the colonoscopy is blinded to the capsule endoscopy findings.
Both examinations are evaluated, documented, and reported using predefined and standardized assessment criteria.
Blinding and Clinical Decision-Making Results from both examinations are communicated to the participant's responsible physician, who is not blinded and determines subsequent diagnostic evaluation, treatment, and continued surveillance in accordance with current clinical guidelines.
Patient-Reported Outcomes Following completion of both procedures, participants complete a structured questionnaire assessing procedural experience, perceived burden, and acceptability of colon capsule endoscopy and conventional colonoscopy. Participants are also asked to indicate their preferred examination modality if diagnostic performance is considered comparable.
Study Timeline Enrolling patients is anticipated from february 2026, with anticipated completion in December 2028.
Scientific Rationale Individuals with Lynch syndrome require lifelong colorectal surveillance beginning at a young age. Conventional colonoscopy, while effective, is invasive and resource intensive, which may affect patient adherence and healthcare capacity. Colon capsule endoscopy is a minimally invasive imaging modality that enables endoluminal visualization of the colon without the need for sedation or endoscope insertion. Evaluation of the diagnostic performance, safety, and patient acceptability of colon capsule endoscopy in this high-risk population may inform future surveillance strategies and optimize resource utilization.
- Conditions
- Lynch Syndrome
- Being tested
- colon capsule endoscopy
- Keywords
- Lynch Syndrome, caspule colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colon capsule endoscopyProcedure or surgery
colon capsule endoscopy
| Study group | Role | What they receive |
|---|---|---|
| adult individuals with genetically confirmed Lynch syndrome scheduled to surveillance-colonoscopy | Not described Receives: Procedure: colon capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance and safety of colon capsule endoscopy compared with conventional colonoscopy
The primary outcome is the diagnostic yield and safety of colon capsule endoscopy (CCE) relative to conventional colonoscopy in patients with genetically confirmed Lynch syndrome. Diagnostic performance will be assessed by the detection of colonic lesions, including polyps, adenomas, and mucosal abnormalities, as evaluated by blinded review of both procedures. Safety will be assessed by recording all adverse events related to the procedure, including capsule retention, gastrointestinal symptoms, or other procedure-related complications occurring on the day of examination and during follow-up until capsule excretion is confirmed.
Measured: perioperative/periprocedural
Secondary outcomes (2)
Complications associated with each examination method
All procedure-related adverse events, including but not limited to gastrointestinal symptoms, capsule retention, or complications related to sedation or endoscopy, will be recorded and compared between colon capsule endoscopy and conventional colonoscopy
Measured: perioperative/periprocedural
Patient acceptability and tolerability of each examination method
Patient-reported outcomes assessing comfort, perceived burden, and overall acceptance of colon capsule endoscopy and conventional colonoscopy will be collected using structured questionnaires. Participants will also indicate which procedure they would prefer if diagnostic performance is considered equivalent.
Measured: perioperative/periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startMay 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Wurm Johansson, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445828
- Sponsor's protocol ID
- 2025-02563-01
- Other IDs
- 2025
- Acronym
- Lynch syndrome
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. The study includes a limited number of participants with a rare hereditary condition, and the dataset contains sensitive clinical and genetic information. Data sharing outside the study group is therefore not planned, in accordance with the approved ethics application, informed consent, and applicable data protection regulations.
Publications
American Gastroenterological Association. Lynch Syndrome: AGA Patient Guideline Summary. Gastroenterology. 2015 Sep;149(3):814-5. doi: 10.1053/j.gastro.2015.07.020. Epub 2015 Jul 26. No abstract available.
PubMed 26219483Sanchez A, Roos VH, Navarro M, Pineda M, Caballol B, Moreno L, Carballal S, Rodriguez-Alonso L, Ramon Y Cajal T, Llort G, Pinol V, Lopez-Fernandez A, Salces I, Pico MD, Rivas L, Bujanda L, Garzon M, Pizarro A, Martinez de Castro E, Lopez-Arias MJ, Poves C, Garau C, Rodriguez-Alcalde D, Herraiz M, Alvarez-Urrutia C, Dacal A, Carrillo-Palau M, Cid L, Ponce M, Barreiro-Alonso E, Saperas E, Aguirre E, Romero C, Bastiaansen B, Gonzalez-Acosta M, Morales-Romero B, Ocana T, Rivero-Sanchez L, Jung G, Bessa X, Cubiella J, Jover R, Rodriguez-Moranta F, Balmana J, Brunet J, Castells A, Dekker E, Capella G, Serra-Burriel M, Moreira L, Pellise M, Balaguer F. Quality of Colonoscopy Is Associated With Adenoma Detection and Postcolonoscopy Colorectal Cancer Prevention in Lynch Syndrome. Clin Gastroenterol Hepatol. 2022 Mar;20(3):611-621.e9. doi: 10.1016/j.cgh.2020.11.002. Epub 2020 Nov 3.
PubMed 33157315Lindberg LJ, Rasmussen M, Andersen KK, Nilbert M, Therkildsen C. Benefit from extended surveillance interval on colorectal cancer risk in Lynch syndrome. Colorectal Dis. 2020 May;22(5):529-536. doi: 10.1111/codi.14926. Epub 2020 Feb 3.
PubMed 31860758Komanduri S, Dominitz JA, Rabeneck L, Kahi C, Ladabaum U, Imperiale TF, Byrne MF, Lee JK, Lieberman D, Wang AY, Sultan S, Shaukat A, Pohl H, Muthusamy VR. AGA White Paper: Challenges and Gaps in Innovation for the Performance of Colonoscopy for Screening and Surveillance of Colorectal Cancer. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2198-2209.e3. doi: 10.1016/j.cgh.2022.03.051. Epub 2022 Jun 7.
PubMed 35688352Bie AKL, Brodersen J. Why do some participants in colorectal cancer screening choose not to undergo colonoscopy following a positive test result? A qualitative study. Scand J Prim Health Care. 2018 Sep;36(3):262-271. doi: 10.1080/02813432.2018.1487520.
PubMed 30238859Kobaek-Larsen M, Kroijer R, Dyrvig AK, Buijs MM, Steele RJC, Qvist N, Baatrup G. Back-to-back colon capsule endoscopy and optical colonoscopy in colorectal cancer screening individuals. Colorectal Dis. 2018 Jun;20(6):479-485. doi: 10.1111/codi.13965.
PubMed 29166546Thygesen MK, Baatrup G, Petersen C, Qvist N, Kroijer R, Kobaek-Larsen M. Screening individuals' experiences of colonoscopy and colon capsule endoscopy; a mixed methods study. Acta Oncol. 2019;58(sup1):S71-S76. doi: 10.1080/0284186X.2019.1581372. Epub 2019 Mar 1.
PubMed 30821625Cortegoso Valdivia P, Skonieczna-Zydecka K, Elosua A, Sciberras M, Piccirelli S, Rullan M, Tabone T, Gawel K, Stachowski A, Leminski A, Marlicz W, Fernandez-Urien I, Ellul P, Spada C, Pennazio M, Toth E, Koulaouzidis A. Indications, Detection, Completion and Retention Rates of Capsule Endoscopy in Two Decades of Use: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Apr 28;12(5):1105. doi: 10.3390/diagnostics12051105.
PubMed 35626261Kroijer R, Kobaek-Larsen M, Qvist N, Knudsen T, Baatrup G. Colon capsule endoscopy for colonic surveillance. Colorectal Dis. 2019 May;21(5):532-537. doi: 10.1111/codi.14557. Epub 2019 Feb 5.
PubMed 30637886Williams MH, Hadjinicolaou AV, Norton BC, Kader R, Lovat LB. Lynch syndrome: from detection to treatment. Front Oncol. 2023 May 1;13:1166238. doi: 10.3389/fonc.2023.1166238. eCollection 2023.
PubMed 37197422Rosvall A, Axelsson M, Toth E, Kumlien C, Gershater MA. Development and content validity testing of a colonoscopy-specific patient-reported experience measure: the Patient Experience Colonoscopy Scale (PECS). J Patient Rep Outcomes. 2024 Mar 18;8(1):32. doi: 10.1186/s41687-024-00710-2.
PubMed 38498225Perrod G, Samaha E, Perez-Cuadrado-Robles E, Berger A, Benosman H, Khater S, Vienne A, Cuenod CA, Zaanan A, Laurent-Puig P, Rahmi G, Cellier C. Effectiveness of a dedicated small bowel neoplasia screening program by capsule endoscopy in Lynch syndrome: 5 years results from a tertiary care center. Ther Adv Gastroenterol. 2020 Jul 29;13:1756284820934314. doi: 10.1177/1756284820934314. eCollection 2020.
PubMed 32774463
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Capsule Colonoscopy in Patients With Lynch Syndrome
- ClinicalTrials.gov ID
- NCT07445828
- Acronym / sponsor ID
- Lynch syndrome / 2025-02563-01
- Conditions
- Lynch Syndrome
- Keywords
- Lynch Syndrome, caspule colonoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lynch syndrome is the most common hereditary cancer syndrome and is caused by pathogenic variants in DNA mismatch repair genes, resulting in a markedly increased lifetime risk of colorectal cancer. The estimated lifetime risk of colorectal cancer varies by the affected gene and is approximately 54-74% in men and 30-52% in women with Lynch syndrome. Colorectal cancer in this population is typically diagnosed at a younger age than in the general population. Current national guidelines recommend colonoscopic surveillance every one to two years beginning at 20-25 years of age to reduce colorectal cancer risk. However, individualized modification of surveillance strategies is under active consideration based on factors such as the specific mutated gene, family history of cancer, smoking status, prior malignancies, and age at surveillance initiation.
Conventional colonoscopy, the current standard method for colorectal evaluation, may cause substantial discomfort or anxiety, leading some patients to decline participation. Colonoscopy is also resource intensive, and procedural capacity is limited. Previously reported limitations in colonoscopy resources and quality in Sweden highlight the need to evaluate alternative surveillance and screening approaches.
Colon capsule endoscopy (CCE) has been available for clinical use since 2006 as a non-invasive alternative to colonoscopy, enabling endoscopic visualization of the entire colon. The system consists of a single-use, swallowable capsule containing miniature cameras that capture images as the capsule progresses through the gastrointestinal tract via natural peristalsis. Images are transmitted wirelessly to a portable data recorder worn by the patient and subsequently reviewed using dedicated software.
CCE offers several advantages compared with conventional colonoscopy and CT colonography, including no requirement for sedation, endoscope insertion, gas insufflation, or ionizing radiation. The examination and image acquisition can be performed outside the hospital setting. This patient-centered approach has the potential to improve adherence to repeated examinations and long-term surveillance programs, which is particularly important for individuals with hereditary colorectal cancer syndromes. CCE may also reduce demands on healthcare resources.
International guidelines indicate that the mucosal diagnostic performance of CCE is comparable to that of standard colonoscopy and that the method is appropriate for screening purposes. Adequate bowel preparation is required for both colonoscopy and CCE. Unlike conventional colonoscopy, bowel cleansing cannot be optimized during CCE, and the procedure is limited by capsule battery life, typically 10-12 hours. To maintain bowel cleanliness and facilitate capsule transit, patients administer laxative and prokinetic agents at predefined time points during the examination.
The primary objective of this study is to evaluate the diagnostic performance and safety of colon capsule endoscopy as a first-line surveillance modality in patients with Lynch syndrome and to assess patient experience and acceptance of CCE compared with conventional colonoscopy.
Detailed description
Detailed Description
Study Overview This is a pragmatic, prospective, observational study designed to compare colon capsule endoscopy (CCE) with conventional colonoscopy in individuals with genetically confirmed Lynch syndrome. The study is conducted within an established colorectal cancer surveillance program and reflects routine clinical practice.
Study Objectives The primary objective of the study is to evaluate the diagnostic performance and safety of colon capsule endoscopy when used as a first-line surveillance examination in patients with genetically confirmed Lynch syndrome. Secondary objectives include assessment of patient-reported experience, acceptability, and preference for colon capsule endoscopy compared with conventional colonoscopy, assuming equivalent diagnostic performance.
Study Design and Procedures Participants undergo both colon capsule endoscopy and conventional colonoscopy using a paired, same-day, blinded design. Colon capsule endoscopy is performed using a standardized bowel preparation protocol. The capsule examination is interpreted by an experienced specialist physician.
Conventional colonoscopy, representing standard of care, is scheduled after confirmed capsule excretion on the same day without additional bowel preparation, or, if necessary, on the morning following the capsule examination. Sedation is offered according to local clinical practice. The endoscopist performing the colonoscopy is blinded to the capsule endoscopy findings.
Both examinations are evaluated, documented, and reported using predefined and standardized assessment criteria.
Blinding and Clinical Decision-Making Results from both examinations are communicated to the participant's responsible physician, who is not blinded and determines subsequent diagnostic evaluation, treatment, and continued surveillance in accordance with current clinical guidelines.
Patient-Reported Outcomes Following completion of both procedures, participants complete a structured questionnaire assessing procedural experience, perceived burden, and acceptability of colon capsule endoscopy and conventional colonoscopy. Participants are also asked to indicate their preferred examination modality if diagnostic performance is considered comparable.
Study Timeline Enrolling patients is anticipated from february 2026, with anticipated completion in December 2028.
Scientific Rationale Individuals with Lynch syndrome require lifelong colorectal surveillance beginning at a young age. Conventional colonoscopy, while effective, is invasive and resource intensive, which may affect patient adherence and healthcare capacity. Colon capsule endoscopy is a minimally invasive imaging modality that enables endoluminal visualization of the colon without the need for sedation or endoscope insertion. Evaluation of the diagnostic performance, safety, and patient acceptability of colon capsule endoscopy in this high-risk population may inform future surveillance strategies and optimize resource utilization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult individuals with genetically confirmed Lynch syndrome scheduled to surveillance-colonoscopy | – | Procedure: colon capsule endoscopy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of adults aged 18-60 years with genetically confirmed Lynch syndrome who are referred for guideline-based surveillance colonoscopy at Skåne University Hospital, Malmö. Eligible participants are identified by referring physicians at the endoscopy unit or gastroenterology outpatient clinic. Consecutive patients who meet the inclusion criteria and have no contraindications to colon capsule endoscopy or study participation are invited to enroll. Participants undergo both non-invasive colon capsule endoscopy and conventional colonoscopy according to the study protocol. Written informed consent is obtained by a study physician prior to any study-related procedures and documented in the medical record. Participation is voluntary, and participants may withdraw at any time without impact on future medical care. A total of 80 consecutive patients will be enrolled. The study evaluates the diagnostic performance and safety of colon capsule endoscopy as a first-line
Key inclusion criteria (3 listed)
- Genetically confirmed Lynch syndrome with a planned surveillance colonoscopy according to guideline-based recommendations
- Age 18-60 years
- Written informed consent obtained
Key exclusion criteria (8 listed)
- Need for an translator
- Known history of gastroparesis or intestinal pseudo-obstruction
- Known or suspected stricture or stenosis of the gastrointestinal tract
- Previous small bowel or colonic resection
- Dysphagia or swallowing difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colon capsule endoscopycolon capsule endoscopy | Procedure or surgery | adult individuals with genetically confirmed Lynch syndrome scheduled to surveillance-colonoscopy |
Primary outcome
Diagnostic performance and safety of colon capsule endoscopy compared with conventional colonoscopy
Time frame: perioperative/periprocedural
The primary outcome is the diagnostic yield and safety of colon capsule endoscopy (CCE) relative to conventional colonoscopy in patients with genetically confirmed Lynch syndrome. Diagnostic performance will be assessed by the detection of colonic lesions, including polyps, adenomas, and mucosal abnormalities, as evaluated by blinded review of both procedures. Safety will be assessed by recording all adverse events related to the procedure, including capsule retention, gastrointestinal symptoms, or other procedure-related complications occurring on the day of examination and during follow-up until capsule excretion is confirmed.
2 secondary outcomes
Complications associated with each examination method
Time frame: perioperative/periprocedural
Patient acceptability and tolerability of each examination method
Time frame: perioperative/periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 26219483American Gastroenterological Association. Lynch Syndrome: AGA Patient Guideline Summary. Gastroenterology. 2015 Sep;149(3):814-5. doi: 10.1053/j.gastro.2015.07.020. Epub 2015 Jul 26. No abstract available.
- Background: PubMed 33157315Sanchez A, Roos VH, Navarro M, Pineda M, Caballol B, Moreno L, Carballal S, Rodriguez-Alonso L, Ramon Y Cajal T, Llort G, Pinol V, Lopez-Fernandez A, Salces I, Pico MD, Rivas L, Bujanda L, Garzon M, Pizarro A, Martinez de Castro E, Lopez-Arias MJ, Poves C, Garau C, Rodriguez-Alcalde D, Herraiz M, Alvarez-Urrutia C, Dacal A, Carrillo-Palau M, Cid L, Ponce M, Barreiro-Alonso E, Saperas E, Aguirre E, Romero C, Bastiaansen B, Gonzalez-Acosta M, Morales-Romero B, Ocana T, Rivero-Sanchez L, Jung G, Bessa X, Cubiella J, Jover R, Rodriguez-Moranta F, Balmana J, Brunet J, Castells A, Dekker E, Capella G, Serra-Burriel M, Moreira L, Pellise M, Balaguer F. Quality of Colonoscopy Is Associated With Adenoma Detection and Postcolonoscopy Colorectal Cancer Prevention in Lynch Syndrome. Clin Gastroenterol Hepatol. 2022 Mar;20(3):611-621.e9. doi: 10.1016/j.cgh.2020.11.002. Epub 2020 Nov 3.
- Background: PubMed 31860758Lindberg LJ, Rasmussen M, Andersen KK, Nilbert M, Therkildsen C. Benefit from extended surveillance interval on colorectal cancer risk in Lynch syndrome. Colorectal Dis. 2020 May;22(5):529-536. doi: 10.1111/codi.14926. Epub 2020 Feb 3.
- Background: PubMed 35688352Komanduri S, Dominitz JA, Rabeneck L, Kahi C, Ladabaum U, Imperiale TF, Byrne MF, Lee JK, Lieberman D, Wang AY, Sultan S, Shaukat A, Pohl H, Muthusamy VR. AGA White Paper: Challenges and Gaps in Innovation for the Performance of Colonoscopy for Screening and Surveillance of Colorectal Cancer. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2198-2209.e3. doi: 10.1016/j.cgh.2022.03.051. Epub 2022 Jun 7.
- Background: PubMed 30238859Bie AKL, Brodersen J. Why do some participants in colorectal cancer screening choose not to undergo colonoscopy following a positive test result? A qualitative study. Scand J Prim Health Care. 2018 Sep;36(3):262-271. doi: 10.1080/02813432.2018.1487520.
- Background: PubMed 29166546Kobaek-Larsen M, Kroijer R, Dyrvig AK, Buijs MM, Steele RJC, Qvist N, Baatrup G. Back-to-back colon capsule endoscopy and optical colonoscopy in colorectal cancer screening individuals. Colorectal Dis. 2018 Jun;20(6):479-485. doi: 10.1111/codi.13965.
- Background: PubMed 30821625Thygesen MK, Baatrup G, Petersen C, Qvist N, Kroijer R, Kobaek-Larsen M. Screening individuals' experiences of colonoscopy and colon capsule endoscopy; a mixed methods study. Acta Oncol. 2019;58(sup1):S71-S76. doi: 10.1080/0284186X.2019.1581372. Epub 2019 Mar 1.
- Background: PubMed 35626261Cortegoso Valdivia P, Skonieczna-Zydecka K, Elosua A, Sciberras M, Piccirelli S, Rullan M, Tabone T, Gawel K, Stachowski A, Leminski A, Marlicz W, Fernandez-Urien I, Ellul P, Spada C, Pennazio M, Toth E, Koulaouzidis A. Indications, Detection, Completion and Retention Rates of Capsule Endoscopy in Two Decades of Use: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Apr 28;12(5):1105. doi: 10.3390/diagnostics12051105.
- Background: PubMed 30637886Kroijer R, Kobaek-Larsen M, Qvist N, Knudsen T, Baatrup G. Colon capsule endoscopy for colonic surveillance. Colorectal Dis. 2019 May;21(5):532-537. doi: 10.1111/codi.14557. Epub 2019 Feb 5.
- Background: PubMed 37197422Williams MH, Hadjinicolaou AV, Norton BC, Kader R, Lovat LB. Lynch syndrome: from detection to treatment. Front Oncol. 2023 May 1;13:1166238. doi: 10.3389/fonc.2023.1166238. eCollection 2023.
- Background: PubMed 38498225Rosvall A, Axelsson M, Toth E, Kumlien C, Gershater MA. Development and content validity testing of a colonoscopy-specific patient-reported experience measure: the Patient Experience Colonoscopy Scale (PECS). J Patient Rep Outcomes. 2024 Mar 18;8(1):32. doi: 10.1186/s41687-024-00710-2.
- Background: PubMed 32774463Perrod G, Samaha E, Perez-Cuadrado-Robles E, Berger A, Benosman H, Khater S, Vienne A, Cuenod CA, Zaanan A, Laurent-Puig P, Rahmi G, Cellier C. Effectiveness of a dedicated small bowel neoplasia screening program by capsule endoscopy in Lynch syndrome: 5 years results from a tertiary care center. Ther Adv Gastroenterol. 2020 Jul 29;13:1756284820934314. doi: 10.1177/1756284820934314. eCollection 2020.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. The study includes a limited number of participants with a rare hereditary condition, and the dataset contains sensitive clinical and genetic information. Data sharing outside the study group is therefore not planned, in accordance with the approved ethics application, informed consent, and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lynch Syndrome, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Wurm Johansson, Docent (+46 40 338662, gabriele.wurmjohansson@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance and safety of colon capsule endoscopy compared with conventional colonoscopy (time frame: perioperative/periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445828, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.