NCT05086601

Brief Summary

This study aims to establish a colorectal cancer cohort, collect clinicopathological information, collect biological samples for multi-omics testing, and perform relevant analysis, to predict the prognosis of colorectal cancer, guide the diagnosis and treatment of colorectal cancer and the formulation of health policies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

October 21, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

September 23, 2021

Last Update Submit

October 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival time

    For patients received radical resection of colorectal cancer, disease-free survival time is defined as time from the surgery to any recurrence of disease or death, recorded in months.

    2 yeas after surgery

Secondary Outcomes (2)

  • Overall survival time

    2 yeas after surgery

  • Pathological TNM stage

    1 month after surgery

Interventions

Any surgery for primary tumor of colorectal cancer, including palliative resection, simple bowel stoma and exploratory surgery.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients pathologically diagnosed as colorectal cancer, and receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery

You may qualify if:

  • Pathologically diagnosed as colorectal cancer
  • Receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery

You may not qualify if:

  • The patient refused to join the study
  • The patient refused to collect the biological sample
  • The patient refused to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The specimens include primary tumor tissue, adjacent tissues, normal mucosa tissue, and peripheral venous blood. Tissue samples will be used for multiple omics tests, including genome, transcriptome, proteome, etc. Blood samples are used for tumor markers, immunology and other tests.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Jianmin Xu, Prof.

CONTACT

Qingyang Feng, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 21, 2021

Study Start

December 1, 2020

Primary Completion

September 9, 2022

Study Completion

September 9, 2022

Last Updated

October 21, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations