NCT07000474

Brief Summary

The primary goal of this observational study is to assess the predictive value of a model developed through a multiparametric analysis of clinical images, histopathological data, CT scans, and molecular analysis. This analysis will be conducted on a retrospective cohort recruited at CHU Brest (training group). The model will then be validated using external cohorts from other centers (test group).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress65%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

May 20, 2025

Last Update Submit

May 30, 2025

Conditions

Keywords

colon cancerrectal cancerradiomics

Outcome Measures

Primary Outcomes (1)

  • survival predictive model

    The primary objective is to evaluate the predictive value of a model built through multiparametric analysis of clinical images, histopathological images, CT scans, and molecular analysis.

    2 years

Study Arms (2)

Brest

Training cohort

Other: Omics

External

Validation cohort

Other: Omics

Interventions

OmicsOTHER

Multiparametric analysis of clinical images, histopathological images, CT scans, and molecular analysis.

BrestExternal

Eligibility Criteria

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

The study population consists of patients diagnosed with colorectal cancer (CRC) who are undergoing various stages of treatment and care. The cohort includes individuals who have been surgically treated for colorectal cancer, with or without additional therapies such as chemotherapy, radiotherapy, or immunotherapy. The population may also include patients who have undergone routine follow-up care after treatment.

You may qualify if:

  • Patients who have undergone surgery for colorectal cancer.

You may not qualify if:

  • Patients under legal protection (guardianship, curatorship, etc.)
  • Refusal to participate (expressed opposition)
  • Individuals with conditions that could interfere with the study protocol or impact data integrity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Brest

Brest, 29200, France

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

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

Study Record Dates

First Submitted

May 20, 2025

First Posted

June 3, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations