Familial Adenomatous PolyposisNCT04531930
Colorectal Adenoma Canceration in FAP
An observational study of Familial Adenomatous Polyposis, run by Changhai Hospital at 1 site in China.
Trial summary
The current internationally accepted treatment method for familial adenomatous polyposis is prophylactic total colorectal resection combined with endoscopic follow-up. However, total colorectal resection will bring a sharp decline in the quality of life of patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Familial Adenomatous Polyposis
- What is being tested?
- surgery, enhanced colonoscopy and self choosed methods
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Sep 2030
- How long will I take part?
- 10 Years
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: The anticipants will be allocated in one of the three groups, and accept the corresponding intervention and at least 3 year follow up.
Who may be able to join
- The initial number of polyps is between 100-1000 visually;
- Pathological diagnosis of multiple lesions confirmed colorectal adenoma;
- Germline mutation detection is clearly a point mutation or large deletion of APC gene;
- No cancer or distant metastasis.
Who cannot join
- Age <18, or >40 years old;
- The initial number of polyps is <100, or >1000;
- The polyp has become cancerous or has suspected distant metastasis;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients who need emergency surgical resection;
- Past history of colorectal surgery;
- Suffering from malignant tumors in other parts and requiring treatment or using chemotherapy drugs or NSAIDs;
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- The patient has contraindications to colonoscopy;
- Patients or family members cannot understand the conditions and goals of this study;
- The patient plans to receive surgical treatment of preventive colorectal resection;
- Other reasons considered by the study doctor to be inappropriate for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cohort Study on Colorectal Adenoma Canceration in Familial Adenomatous Polyposis
The current internationally accepted treatment method for familial adenomatous polyposis is prophylactic total colorectal resection combined with endoscopic follow-up. However, total colorectal resection will bring a sharp decline in the quality of life of patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery.
Read the detailed description
Familial adenomatous polyposis is a kind of colorectal cancer syndrome, which belongs to rare diseases. It is estimated that the number of patients in China is about 100,000, accounting for about 1% of all colorectal cancer patients. This type of patients onset between the ages of ten and thirty years old. The typical manifestation is the growth of tens to thousands of colorectal adenomas, and the lifetime risk of colorectal cancer is close to 100%, accompanied by multiple extraintestinal manifestations . Without treatment, the average life span is 40-50 years. The current internationally accepted treatment method is prophylactic total colorectal resection combined with endoscopic follow-up. This program has a significant effect and can extend life expectancy by 10-20 years. However, total colorectal resection will bring a sharp decline in the quality of life of patients. The patients will lose many abilities (working ability, social ability, fertility, etc.) from the age of 20, and the prolonged survival period also brings more misery. This, in turn, also reduces the compliance of treatment. Many patients refuse to accept surgery and turn to endoscopic treatment or even give up treatment. However, there is currently no evidence that methods other than prophylactic surgery can effectively control the risk of colorectal cancer in such patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. Among them, the intensive colonoscopy treatment group will be treated with colonoscopy intensive treatment (that is, colonoscopy treatment is performed every 3 months, Carry out colorectal tumor reduction in segments, and continue to control the growth of adenomas several times) for patients who refuse surgery. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery, so as to explore ways to improve the quality of life of such patients.
- Conditions
- Familial Adenomatous Polyposis
- Being tested
- surgery, enhanced colonoscopy, self choosed methods
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
Colorectal surgery, mainly total proctocolectomy.
enhanced colonoscopyProcedure or surgery
Colonoscopic treatment and surveillance in every 3 months.
self choosed methodsOther
A patient chooses a method for himself other than surgery.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Group | Colorectal surgery Receives: Procedure: surgery | |
| Enhanced Colonoscopy Group | Enhanced colonoscopic treatment and surveillance Receives: Procedure: enhanced colonoscopy | |
| Self Choice Group | The patients choose the interventional methods, even do nothing. Receives: Other: self choosed methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
3yCR
3 year Cancerous rate
Measured: 3 years
Secondary outcomes (2)
Adenoma number Change
Change of adenoma number by 3 years
Measured: 3 years
3yOSR
3 year overall survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- 124 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, En-Da Yu, Changhai Hospital
- Investigators
- Jun-Jie XING, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531930
- Sponsor's protocol ID
- SINOFAP2020A
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karstensen JG, Burisch J, Pommergaard HC, Aalling L, Hojen H, Jespersen N, Schmidt PN, Bulow S. Colorectal Cancer in Individuals With Familial Adenomatous Polyposis, Based on Analysis of the Danish Polyposis Registry. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2294-2300.e1. doi: 10.1016/j.cgh.2019.02.008. Epub 2019 Feb 8.
PubMed 30743005Bulow S. Results of national registration of familial adenomatous polyposis. Gut. 2003 May;52(5):742-6. doi: 10.1136/gut.52.5.742.
PubMed 12692062
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Colorectal Adenoma Canceration in Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT04531930
- Acronym / sponsor ID
- SINOFAP2020A
- Conditions
- Familial Adenomatous Polyposis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 31 Aug 2020 (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.
The current internationally accepted treatment method for familial adenomatous polyposis is prophylactic total colorectal resection combined with endoscopic follow-up. However, total colorectal resection will bring a sharp decline in the quality of life of patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery.
Detailed description
Familial adenomatous polyposis is a kind of colorectal cancer syndrome, which belongs to rare diseases. It is estimated that the number of patients in China is about 100,000, accounting for about 1% of all colorectal cancer patients. This type of patients onset between the ages of ten and thirty years old. The typical manifestation is the growth of tens to thousands of colorectal adenomas, and the lifetime risk of colorectal cancer is close to 100%, accompanied by multiple extraintestinal manifestations . Without treatment, the average life span is 40-50 years. The current internationally accepted treatment method is prophylactic total colorectal resection combined with endoscopic follow-up. This program has a significant effect and can extend life expectancy by 10-20 years. However, total colorectal resection will bring a sharp decline in the quality of life of patients. The patients will lose many abilities (working ability, social ability, fertility, etc.) from the age of 20, and the prolonged survival period also brings more misery. This, in turn, also reduces the compliance of treatment. Many patients refuse to accept surgery and turn to endoscopic treatment or even give up treatment. However, there is currently no evidence that methods other than prophylactic surgery can effectively control the risk of colorectal cancer in such patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. Among them, the intensive colonoscopy treatment group will be treated with colonoscopy intensive treatment (that is, colonoscopy treatment is performed every 3 months, Carry out colorectal tumor reduction in segments, and continue to control the growth of adenomas several times) for patients who refuse surgery. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery, so as to explore ways to improve the quality of life of such patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgery Group | – | Procedure: surgeryColorectal surgery |
| Enhanced Colonoscopy Group | – | Procedure: enhanced colonoscopyEnhanced colonoscopic treatment and surveillance |
| Self Choice Group | – | Other: self choosed methodsThe patients choose the interventional methods, even do nothing. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The anticipants will be allocated in one of the three groups, and accept the corresponding intervention and at least 3 year follow up.
Key inclusion criteria (4 listed)
- The initial number of polyps is between 100-1000 visually;
- Pathological diagnosis of multiple lesions confirmed colorectal adenoma;
- Germline mutation detection is clearly a point mutation or large deletion of APC gene;
- No cancer or distant metastasis.
Key exclusion criteria (10 listed)
- Age <18, or >40 years old;
- The initial number of polyps is <100, or >1000;
- The polyp has become cancerous or has suspected distant metastasis;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients who need emergency surgical resection;
- Past history of colorectal surgery;
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 |
|---|---|---|
| surgeryColorectal surgery, mainly total proctocolectomy. | Procedure or surgery | Surgery Group |
| enhanced colonoscopyColonoscopic treatment and surveillance in every 3 months. | Procedure or surgery | Enhanced Colonoscopy Group |
| self choosed methodsA patient chooses a method for himself other than surgery. | Other | Self Choice Group |
Primary outcome
3yCR
Time frame: 3 years
3 year Cancerous rate
2 secondary outcomes
Adenoma number Change
Time frame: 3 years
3yOSR
Time frame: 3 years
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 31 Aug 2020.
- Background: PubMed 30743005Karstensen JG, Burisch J, Pommergaard HC, Aalling L, Hojen H, Jespersen N, Schmidt PN, Bulow S. Colorectal Cancer in Individuals With Familial Adenomatous Polyposis, Based on Analysis of the Danish Polyposis Registry. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2294-2300.e1. doi: 10.1016/j.cgh.2019.02.008. Epub 2019 Feb 8.
- Background: PubMed 12692062Bulow S. Results of national registration of familial adenomatous polyposis. Gut. 2003 May;52(5):742-6. doi: 10.1136/gut.52.5.742.
- Individual participant dataSharing planned: No
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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.
Jun-Jie XING, MD principal investigator
Changhai Hospital
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 Familial Adenomatous Polyposis, run by Changhai Hospital at 1 site in China.
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 10 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 31 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 1 site in China. 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 En-Da YU, MBBS (8613901688626, endayu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3yCR (time frame: 3 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 NCT04531930, which also lists 2 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 31 Aug 2020.