Clinical trial · Observational
Next-generation Sequencing of Colorectal Cancer Somatic Cells to Guide Genetic Susceptibility Gene Mutations Screening.
An Exploratory Study of Next-generation Sequencing in Colorectal Cancer Somatic Cells to Guide Screening for Genetic Susceptibility Gene Mutations.
NCT04280666CI-TRIAL-00043554unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- sensitivity, specificity, positive predictive value, and negative predictive value
- timeFrame
- 1.5 years
- description
- 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.
Secondary outcomes (2)
- measure
- pedigree verification of candidate patients
- timeFrame
- 3.5 years
- description
- 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.
- measure
- Characteristics of the gene map and the correlations with clinical characteristics
- timeFrame
- 3.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.