NCT06130644

Brief Summary

The prognostic implications of lymph node metastasis in colorectal cancer patients at an early stage, specifically T1/2 stage, are relatively unfavorable. Therefore, understanding the clinical and molecular traits relevant to metastasis in T1/2 stage are of substantial clinical importance.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,451

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

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

January 1, 2003

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

20 years

First QC Date

November 1, 2023

Last Update Submit

November 8, 2023

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • MSI status

    (I) MSI-High (MSI-H) if two or more mononucleotide markers in tumor tissue had size variations of ≥3bp compared to normal tissue; (II) MSI-Low (MSI-L) if a single mononucleotide marker in tumor tissue exhibited a size variation of ≥3bp compared to normal tissue; (III) Microsatellite Stable (MSS) if there were no size variations of ≥3bp in mononucleotide markers in tumor tissue compared to normal tissue.

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Somatic Mutation Distribution

    through study completion, an average of 1 year

  • Tumor Mutation Burden (TMB)

    through study completion, an average of 1 year

Study Arms (2)

Patients with lymph node metastasis

T1/2N+ patients

Patients without lymph node metastasis

T1/2N- patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Colorectal cancer patients.

You may qualify if:

  • Men and women aged 18-75 years old;
  • Clinical staged T2;
  • Histologically proven colon or rectal adenocarcinoma.

You may not qualify if:

  • Patients over 80 years of age;
  • Recurrent colorectal cancer;
  • Multiple primary tumors;
  • Distant metastasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 14, 2023

Study Start

January 1, 2003

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share