Colorectal PolyposisNCT04961125
Multicenter Study on the Pathogenic Germline Gene Variants of Colorectal Polyposis in China
An observational study of Colorectal Polyposis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
Trial summary
Patients suspected of adenomatous polyposis were included. The criteria used were more than 10 polyps observed under colonoscopy, and pathological confirmation of adenoma. Clinical data and pedigree information were collected. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Polyposis
- What is being tested?
- germline variants
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- 2 Aug 2021to 31 Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients suspected of adenomatous polyposis, with more than 10 polyps observed under colonoscopy, and pathological confirmation of adenoma.
Who may be able to join
- clinical diagnosis of adenomatous polyposis;
- enough samples (provide at least 5ml of peripheral whole blood) for germline variant detection
Who cannot join
- genetic diagnosis of polyposis syndrome
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
General Hospital of Air Force
Beijing, Beijing Municipality
Guoli Gu, MD
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Daici Chen, PhD
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Haixing Ju, MD
- Recruiting
SAHZU
Hangzhou, Zhejinag, 310009
Ying Yuan, Ph.D & MD, yuanying1999@zju.edu.cn
Ying Yuan, yuanying1999@zju.edu.cn
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Yanhong Gu, MD
About this study
Patients suspected of adenomatous polyposis were included. The criteria used were more than 10 polyps observed under colonoscopy, and pathological confirmation of adenoma. Clinical data and pedigree information were collected. The variants of 139 genes associated with different hereditary cancers and polyposis were screened by NGS, which was performed by Genetron Health on the HiSeqX-ten sequencing platform.
- Conditions
- Colorectal Polyposis
- Being tested
- germline variants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
germline variantsGenetic
Variants of 139 genes associated with different hereditary cancers and polyposis were screened by next-generation sequencing.
| Study group | Role | What they receive |
|---|---|---|
| colorectal polyposis | Not described Receives: Genetic: germline variants |
What is being measured
The primary outcome is the main question the study is designed to answer.
germline variant detection rate in the polyposis population
germline variant detection rate in the polyposis population
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start2 Aug 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolyposisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961125
- Sponsor's protocol ID
- 2017-072
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on the Pathogenic Germline Gene Variants of Colorectal Polyposis in China
- ClinicalTrials.gov ID
- NCT04961125
- Acronym / sponsor ID
- 2017-072
- Conditions
- Colorectal Polyposis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 2 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jul 2021 (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.
Patients suspected of adenomatous polyposis were included. The criteria used were more than 10 polyps observed under colonoscopy, and pathological confirmation of adenoma. Clinical data and pedigree information were collected. The variants of 139 genes associated with different hereditary cancers and polyposis were screened by NGS, which was performed by Genetron Health on the HiSeqX-ten sequencing platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal polyposis | – | Genetic: germline variants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients suspected of adenomatous polyposis, with more than 10 polyps observed under colonoscopy, and pathological confirmation of adenoma.
Key inclusion criteria (2 listed)
- clinical diagnosis of adenomatous polyposis;
- enough samples (provide at least 5ml of peripheral whole blood) for germline variant detection
Key exclusion criteria (1 listed)
- genetic diagnosis of polyposis syndrome
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 |
|---|---|---|
| germline variantsVariants of 139 genes associated with different hereditary cancers and polyposis were screened by next-generation sequencing. | Genetic | colorectal polyposis |
Primary outcome
germline variant detection rate in the polyposis population
Time frame: through study completion, an average of 3 years
germline variant detection rate in the polyposis population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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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. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyposis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Yuan, PhD (86-13858193601, yuanying1999@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
germline variant detection rate in the polyposis population (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2021.