Next-generation Sequencing of Colorectal Cancer Somatic Cells to Guide Genetic Susceptibility Gene Mutations Screening.

NCT04280666 | Unknown

• 1 other identifier: FDCRC49-LFQ
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hereditary Colorectal Cancer

Keywords

Colorectal Cancer; Next-generation sequencing; Genetic Susceptibility

Outcome Measures

Primary Outcomes (1)

• 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.

  1.5 years

Secondary Outcomes (2)

• pedigree verification of candidate patients

  3.5 years

• Characteristics of the gene map and the correlations with clinical characteristics

  3.5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

270 Dongan Road, Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and formalin-fixed tissue

MeSH Terms

Conditions

Colorectal Neoplasms; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fangqi Liu, M.D. Ph.D.

CONTACT

+86 18017317123; liufq021@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 21, 2020
• Study Start: June 20, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

CN (1)