NCT03976960

Brief Summary

Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress63%
Sep 2018Dec 2030

Study Start

First participant enrolled

September 19, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

7.2 years

First QC Date

June 5, 2019

Last Update Submit

February 11, 2025

Conditions

Keywords

cancercolontumorcolic

Outcome Measures

Primary Outcomes (2)

  • Number of clinical risk factors for colorectal cancer

    Until the study completion : 6 years

  • Number of biological risk factors for colorectal cancer

    Until the study completion : 6 years

Study Arms (1)

Biological collection

EXPERIMENTAL

For all the patients include in the study : samples of blood samples collected before or after surgery but also samples in paraffin-embedded tissue sections. In parallel to this biological collection, standardized clinical data will be entered into a database

Other: Biological collection

Interventions

The biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections.

Biological collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing colon cancer surgery (stage I, II, III and IV)
  • Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer
  • Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
  • Patient with familial polyposis eligible for colectomy
  • Age \> 18 years
  • Signed informed consent

You may not qualify if:

  • Patient not affiliated to Social Protection system
  • Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
  • Patient under guardianship
  • Minor patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Montpellier

Montpellier, Hérault, 34298, France

RECRUITING

Institut Régional du cancer de Montpellier

Montpellier, 34298, France

RECRUITING

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasmsColic

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • ERIC ASSENAT, M.D

    Institut régional du cancer de Montpellier

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 6, 2019

Study Start

September 19, 2018

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations