Hereditary Colorectal CancerNCT04280666
Next-generation Sequencing of Colorectal Cancer Somatic Cells to Guide Genetic Susceptibility Gene Mutations Screening.
An observational study of Hereditary Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, single-center, clinical study.This study is to evaluate the feasibility of genetic susceptibility screening based on the detection of tumor tissue mutations by a NGS panel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Colorectal Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2019to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal cancer patients who meet the relevant clinical screening standards (such as Amsterdam standard (I / II), Bethesda standard (Revised Version) and China expert consensus on clinical diagnosis, treatment and family management of hereditary colorectal cancer.
Who may be able to join
- A biopsy proven histological diagnosis of colorectal carcinoma.
- ≥ 18 years of age on the day of signing informed consent.
- Patients must meet the relevant clinical screening standards, such as the Amsterdam Standard (I / II),etc.
- Patients need to provide tumor tissue samples and matched peripheral blood (leukocyte) samples.
Who cannot join
- History of other malignant tumors(except for cervical carcinoma in situ, basal or squamous cell skin cancer which has been fully treated).
- There is no detailed histopathological report to judge the nature of the lesions.
- Any social or psychological problems, etc., which are judged by the researcher to be unsuitable for the study.
- For various reasons, the baseline samples (tumor tissue samples, peripheral blood samples) were incomplete.
- Patients who are unwilling or unable to follow the research program for long-term and regular follow-up in current medical institutions.
- Failure to complete the follow-up within 2 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, 200032
Fangqi Liu, M.D. Ph.D, +86 18017317123, liufq021@163.com
About this study
Official title: An Exploratory Study of Next-generation Sequencing in Colorectal Cancer Somatic Cells to Guide Screening for Genetic Susceptibility Gene Mutations.
This is a prospective, single-center, clinical study.This study is to evaluate the feasibility of genetic susceptibility screening based on the detection of tumor tissue mutations by a NGS panel.
Read the detailed description
In this study, gene mutation profiling was performed on primary tissue samples from colorectal cancer patients who met relevant clinical screening criteria, unearthing suspected germline pathogenic mutations. At the same time, germline mutation detection was performed on peripheral blood leukocytes of patients, and the consistency between suspected germline mutations in tumor somatic mutation detection and control leukocytes was compared. Establishing the feasibility of tumor somatic mutation-based detection to guide genetic susceptibility screening.Pedigree verification will be carried out for blood relatives of patients with germline mutations which have been identified for colorectal cancer.Through the tumor somatic and germline gene mutation profiles of Chinese hereditary colorectal cancer patients, it reveals the molecular characteristics of hereditary colorectal cancer in Asian populations and provides molecular-level evidence for possible subsequent clinical diagnosis and treatment.
- Conditions
- Hereditary Colorectal Cancer
- Keywords
- Colorectal Cancer, Next-generation sequencing, Genetic Susceptibility
- Medical subject headings
- Colorectal Neoplasms, Genetic Predisposition to Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificity, positive predictive value, and negative predictive value
Assessing the sensitivity, specificity, positive predictive value, and negative predictive value of genetic susceptibility gene mutations screening based on a targeted Next-generation sequencing panel.
Measured: 1.5 years
Secondary outcomes (2)
pedigree verification of candidate patients
Screening for leukocyte mutations in blood relatives of the hereditary colorectal cancer patients with germline mutations.Preliminary analysis of the distribution, clinical characteristics, molecular typing and prognosis of Chinese hereditary colorectal cancer patients and their families.
Measured: 3.5 years
Characteristics of the gene map and the correlations with clinical characteristics
Gene map characteristics of tissue samples from colorectal cancer patients who meet the relevant clinical screening criteria and their correlations with clinical characteristics (age, gender, family history, etc.)
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start20 Jun 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangqi Liu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280666
- Sponsor's protocol ID
- FDCRC49-LFQ
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 21 Feb 2020
- 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 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Next-generation Sequencing in Colorectal Cancer Somatic Cells to Guide Screening for Genetic Susceptibility Gene Mutations.
- ClinicalTrials.gov ID
- NCT04280666
- Acronym / sponsor ID
- FDCRC49-LFQ
- Conditions
- Hereditary Colorectal Cancer
- Keywords
- Colorectal Cancer, Next-generation sequencing, Genetic Susceptibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Feb 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.
This is a prospective, single-center, clinical study.This study is to evaluate the feasibility of genetic susceptibility screening based on the detection of tumor tissue mutations by a NGS panel.
Detailed description
In this study, gene mutation profiling was performed on primary tissue samples from colorectal cancer patients who met relevant clinical screening criteria, unearthing suspected germline pathogenic mutations. At the same time, germline mutation detection was performed on peripheral blood leukocytes of patients, and the consistency between suspected germline mutations in tumor somatic mutation detection and control leukocytes was compared. Establishing the feasibility of tumor somatic mutation-based detection to guide genetic susceptibility screening.Pedigree verification will be carried out for blood relatives of patients with germline mutations which have been identified for colorectal cancer.Through the tumor somatic and germline gene mutation profiles of Chinese hereditary colorectal cancer patients, it reveals the molecular characteristics of hereditary colorectal cancer in Asian populations and provides molecular-level evidence for possible subsequent clinical diagnosis and treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients who meet the relevant clinical screening standards (such as Amsterdam standard (I / II), Bethesda standard (Revised Version) and China expert consensus on clinical diagnosis, treatment and family management of hereditary colorectal cancer.
Key inclusion criteria (4 listed)
- A biopsy proven histological diagnosis of colorectal carcinoma.
- ≥ 18 years of age on the day of signing informed consent.
- Patients must meet the relevant clinical screening standards, such as the Amsterdam Standard (I / II),etc.
- Patients need to provide tumor tissue samples and matched peripheral blood (leukocyte) samples.
Key exclusion criteria (6 listed)
- History of other malignant tumors(except for cervical carcinoma in situ, basal or squamous cell skin cancer which has been fully treated).
- There is no detailed histopathological report to judge the nature of the lesions.
- Any social or psychological problems, etc., which are judged by the researcher to be unsuitable for the study.
- For various reasons, the baseline samples (tumor tissue samples, peripheral blood samples) were incomplete.
- Patients who are unwilling or unable to follow the research program for long-term and regular follow-up in current medical institutions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensitivity, specificity, positive predictive value, and negative predictive value
Time frame: 1.5 years
Assessing the sensitivity, specificity, positive predictive value, and negative predictive value of genetic susceptibility gene mutations screening based on a targeted Next-generation sequencing panel.
2 secondary outcomes
pedigree verification of candidate patients
Time frame: 3.5 years
Characteristics of the gene map and the correlations with clinical characteristics
Time frame: 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
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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.
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 Hereditary Colorectal Cancer, run by Fudan University 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 6 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 21 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangqi Liu, M.D. Ph.D. (+86 18017317123, liufq021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity, specificity, positive predictive value, and negative predictive value (time frame: 1.5 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 21 Feb 2020.