NCT03928652

Brief Summary

The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.

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
1,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

April 24, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

3.9 years

First QC Date

April 24, 2019

Last Update Submit

April 24, 2019

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Failure-free Survival

    3 years

  • Tumor regression grade

    For rectal cancer patients who receive neoadjuvant treatment

    1 year

Secondary Outcomes (1)

  • Overall survival

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with newly histologically confirmed colorectal cancer and no evidence of distant metastasis

You may qualify if:

  • Colon or rectal cancer diagnosed by endoscopic biopsy histopathology;
  • Complete sample information, including sample number, gender, age and clinical molecular diagnostic information, etc.;
  • Sufficient surgical tissue samples are available for testing;
  • untreated colon or rectal cancer patients;
  • Patient able to understand and sign written informed consent
  • No evidence of distant metastasis (M0)

You may not qualify if:

  • Previously treated CRC, including cytotoxic drug therapy, targeted drug therapy, etc.;
  • Other malignant tumors;
  • Pregnant women;
  • Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yet-sen University

Guangzhou, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and tumor tissue

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ping Lan, PhD

CONTACT

86-20-38254009sumslp@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 26, 2019

Study Start

April 24, 2019

Primary Completion

April 1, 2023

Study Completion

December 1, 2023

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations

CN(1)