Colorectal CancerNCT02567045
Uptake to Colorectal Cancer Screening in Familial-risk Population
A study testing annual FIT and colonoscopy in case of a positive test and colonoscopy with sedation in people with Colorectal Cancer and Screening Uptake of Colonoscopy and FIT, run by Hospital Universitario de Canarias at 7 sites in Spain.
Trial summary
This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Colorectal Cancer, Screening Uptake of Colonoscopy and FIT
- What is being tested?
- annual FIT and colonoscopy in case of a positive test and colonoscopy with sedation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 7 sitesSpain
- Study dates
- 25 Feb 2016to 24 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- FDR with a case index meeting the following conditions: at least one case index < 60 years at diagnosis of the CCR;
- having ≥ 2 FDRs with CRC regardless the age of the case index at diagnosis;
- having a sibling with CRC;
- age <75 years.
Who cannot join
- past CRC screening;
- inflammatory bowel disease or past history of colorectal neoplasia;
- Family history of hereditary CRC;
- Abdominal symptoms;
- Colectomy;
- Severe comorbidity leading to a poor prognosis (life expectancy < 5 years);
- Refusal to participate in the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
María Rodriguez Soler
Alicante, 03010
Cristina Alvarez Urturi, MD
Barcelona, Catalonia, 08003
Maria Teresa Ocaña Bombardo
Barcelona, Catalonia, 08036
Inés Castro Novo
Ourense, Galicia, 32005
Digestive Service, Huc
San Cristóbal de La Laguna, S/C de Tenerife, 38320
Patricia Muñoz Garrrido
San Sebastián, País Vasco, Gipuzcoa, 20080
Federico Sopeña Biarge
Zaragoza, Aragon, 50009
About this study
Official title: Uptake to Colorectal Cancer Screening in Familiar-risk Population: A Randomized Controlled Trial Comparing Immunochemical Fecal Occult Blood Test With Colonoscopy
This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).
The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.
Read the detailed description
This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients diagnosed of CRC.
The recruitment process will be programmed through the index case, that will be interviewed to obtain their CRC family history. FDR will be contacted in order to make an appointment in the High-risk CRC Clinic of the participant centers. Randomization will be performed before signing the informed consent to avoid selection bias. A researcher will be responsible to provide detailed information about the study and getting the informed consent. In case of willingness to participate in the study, the FDR will be randomized to one of the following arms: A) One-time colonoscopy; B) annual FIT for two screening rounds and a colonoscopy in case of a positive FIT (cut-off = 10 μg Hemoglobin/g feces). Screening uptake will be defined as the percentage of FDR who participate at least in one of the two FIT screening round in the FIT group or who undergo colonoscopy in the other group. Screening uptake will be calculated under the assumption of intention to screen analysis.
The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.
- Being tested
- annual FIT and colonoscopy in case of a positive test, colonoscopy with sedation
- Keywords
- Immunochemical fecal occult blood test, Colonoscopy, Screening uptake, Screening participation, Familiar risk, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
annual FIT and colonoscopy in case of a positive testProcedure or surgery
FIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces.
colonoscopy with sedationProcedure or surgery
One-time Colonoscopy with sedation.
| Study group | Role | What they receive |
|---|---|---|
| Fecal occult blood testing | Experimental | Annual FIT and colonoscopy in case of a positive test. Fecal occult blood testing: annual FIT (two rounds) without diet restriction, one stool sample. Positive cut-off = 10 μg Hemoglobin/g feces.
Colonoscopy will be performed in case of a positive FIT. Receives: Procedure: annual FIT and colonoscopy in case of a positive test; Procedure: colonoscopy with sedation |
| one-time Colonoscopy | Active comparator | One-time Colonoscopy with sedation Receives: Procedure: colonoscopy with sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who participate in each screening arm
Measured: 2 years
Secondary outcomes (2)
Efficacy measure: QALYs (Quality adjusted life years).
Measured: 2 years
Costs measure: cost (euros) of the procedures associated with each screening strategy and treatment of advanced neoplastic lesions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start25 Feb 2016
- Primary completion31 Dec 2019
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Quintero, MD, PhD, Study director, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567045
- Sponsor's protocol ID
- Colorectal cancer screening
- Status last verified
- Aug 2020
- First submitted
- 29 Sep 2015
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
PubMed 25127679Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895.
PubMed 22356323Pappadopulos E, Jensen PS, Chait AR, Arnold LE, Swanson JM, Greenhill LL, Hechtman L, Chuang S, Wells KC, Pelham W, Cooper T, Elliott G, Newcorn JH. Medication adherence in the MTA: saliva methylphenidate samples versus parent report and mediating effect of concomitant behavioral treatment. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):501-510. doi: 10.1097/CHI.0b013e31819c23ed.
PubMed 19307987Dove-Edwin I, Sasieni P, Adams J, Thomas HJ. Prevention of colorectal cancer by colonoscopic surveillance in individuals with a family history of colorectal cancer: 16 year, prospective, follow-up study. BMJ. 2005 Nov 5;331(7524):1047. doi: 10.1136/bmj.38606.794560.EB. Epub 2005 Oct 21.
PubMed 16243849Gonzalez-Lopez N, Quintero E, Gimeno-Garcia AZ, Bujanda L, Banales J, Cubiella J, Salve-Bouzo M, Herrero-Rivas JM, Cid-Delgado E, Alvarez-Sanchez V, Ledo-Rodriguez A, de-Castro-Parga ML, Fernandez-Poceiro R, Sanroman-Alvarez L, Santiago-Garcia J, Herreros-de-Tejada A, Ocana-Bombardo T, Balaguer F, Rodriguez-Soler M, Jover R, Ponce M, Alvarez-Urturi C, Bessa X, Roncales MP, Sopena F, Lanas A, Nicolas-Perez D, Adrian-de-Ganzo Z, Carrillo-Palau M, Gonzalez-Davila E; Oncology Group of Asociacion Espanola de Gastroenterologia. Screening uptake of colonoscopy versus fecal immunochemical testing in first-degree relatives of patients with non-syndromic colorectal cancer: A multicenter, open-label, parallel-group, randomized trial (ParCoFit study). PLoS Med. 2023 Oct 24;20(10):e1004298. doi: 10.1371/journal.pmed.1004298. eCollection 2023 Oct.
PubMed 37874831
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uptake to Colorectal Cancer Screening in Familiar-risk Population: A Randomized Controlled Trial Comparing Immunochemical Fecal Occult Blood Test With Colonoscopy
- ClinicalTrials.gov ID
- NCT02567045
- Acronym / sponsor ID
- Colorectal cancer screening
- Keywords
- Immunochemical fecal occult blood test, Colonoscopy, Screening uptake, Screening participation, Familiar risk, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 2 Oct 2015 (estimated)
- 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.
This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).
The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.
Detailed description
This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients diagnosed of CRC.
The recruitment process will be programmed through the index case, that will be interviewed to obtain their CRC family history. FDR will be contacted in order to make an appointment in the High-risk CRC Clinic of the participant centers. Randomization will be performed before signing the informed consent to avoid selection bias. A researcher will be responsible to provide detailed information about the study and getting the informed consent. In case of willingness to participate in the study, the FDR will be randomized to one of the following arms: A) One-time colonoscopy; B) annual FIT for two screening rounds and a colonoscopy in case of a positive FIT (cut-off = 10 μg Hemoglobin/g feces). Screening uptake will be defined as the percentage of FDR who participate at least in one of the two FIT screening round in the FIT group or who undergo colonoscopy in the other group. Screening uptake will be calculated under the assumption of intention to screen analysis.
The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal occult blood testing | Experimental | Procedure: annual FIT and colonoscopy in case of a positive test, Procedure: colonoscopy with sedationAnnual FIT and colonoscopy in case of a positive test. Fecal occult blood testing: annual FIT (two rounds) without diet restriction, one stool sample. Positive cut-off = 10 μg Hemoglobin/g feces. Colonoscopy will be performed in case of a positive FIT. |
| one-time Colonoscopy | Active comparator | Procedure: colonoscopy with sedationOne-time Colonoscopy with sedation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- FDR with a case index meeting the following conditions: at least one case index < 60 years at diagnosis of the CCR;
- having ≥ 2 FDRs with CRC regardless the age of the case index at diagnosis;
- having a sibling with CRC;
- age <75 years.
Key exclusion criteria (7 listed)
- past CRC screening;
- inflammatory bowel disease or past history of colorectal neoplasia;
- Family history of hereditary CRC;
- Abdominal symptoms;
- Colectomy;
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 |
|---|---|---|
| annual FIT and colonoscopy in case of a positive testFIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces. | Procedure or surgery | Fecal occult blood testing |
| colonoscopy with sedationOne-time Colonoscopy with sedation. | Procedure or surgery | Fecal occult blood testing, one-time Colonoscopy |
Primary outcome
Proportion of patients who participate in each screening arm
Time frame: 2 years
2 secondary outcomes
Efficacy measure: QALYs (Quality adjusted life years).
Time frame: 2 years
Costs measure: cost (euros) of the procedures associated with each screening strategy and treatment of advanced neoplastic lesions
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Results publication: PubMed 25127679Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
- Results publication: PubMed 22356323Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895.
- Results publication: PubMed 19307987Pappadopulos E, Jensen PS, Chait AR, Arnold LE, Swanson JM, Greenhill LL, Hechtman L, Chuang S, Wells KC, Pelham W, Cooper T, Elliott G, Newcorn JH. Medication adherence in the MTA: saliva methylphenidate samples versus parent report and mediating effect of concomitant behavioral treatment. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):501-510. doi: 10.1097/CHI.0b013e31819c23ed.
- Results publication: PubMed 16243849Dove-Edwin I, Sasieni P, Adams J, Thomas HJ. Prevention of colorectal cancer by colonoscopic surveillance in individuals with a family history of colorectal cancer: 16 year, prospective, follow-up study. BMJ. 2005 Nov 5;331(7524):1047. doi: 10.1136/bmj.38606.794560.EB. Epub 2005 Oct 21.
- Derived from this study: PubMed 37874831Gonzalez-Lopez N, Quintero E, Gimeno-Garcia AZ, Bujanda L, Banales J, Cubiella J, Salve-Bouzo M, Herrero-Rivas JM, Cid-Delgado E, Alvarez-Sanchez V, Ledo-Rodriguez A, de-Castro-Parga ML, Fernandez-Poceiro R, Sanroman-Alvarez L, Santiago-Garcia J, Herreros-de-Tejada A, Ocana-Bombardo T, Balaguer F, Rodriguez-Soler M, Jover R, Ponce M, Alvarez-Urturi C, Bessa X, Roncales MP, Sopena F, Lanas A, Nicolas-Perez D, Adrian-de-Ganzo Z, Carrillo-Palau M, Gonzalez-Davila E; Oncology Group of Asociacion Espanola de Gastroenterologia. Screening uptake of colonoscopy versus fecal immunochemical testing in first-degree relatives of patients with non-syndromic colorectal cancer: A multicenter, open-label, parallel-group, randomized trial (ParCoFit study). PLoS Med. 2023 Oct 24;20(10):e1004298. doi: 10.1371/journal.pmed.1004298. eCollection 2023 Oct.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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. This study is not recruiting at the moment.
Enrique Quintero, MD, PhD study director
Hospital Universitario de Canarias
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing annual FIT and colonoscopy in case of a positive test and colonoscopy with sedation in people with Colorectal Cancer and Screening Uptake of Colonoscopy and FIT, run by Hospital Universitario de Canarias at 7 sites in Spain.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who participate in each screening arm (time frame: 2 years). 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 NCT02567045, which also lists 5 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 10 Aug 2020.