FLUORIB: Impact of 5-Fluorouracil (5-FU) on Cancer Cells From Liver Metastases of Colon Cancer

Sponsor
Centre Leon Berard (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04274790
Collaborator
(none)
100
1
21
4.8

Study Details

Study Description

Brief Summary

Analyze the dynamics of incorporation of 5-fluorouracil into cancer cell ribosomes from liver metastases of patient with metastatic colon cancer.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Scheduled and planned surgery

Detailed Description

This is a monocentric, prospective, non-interventional cohort study in adult patients with metastatic colon cancer with hepatics metastasis.

Tumour samples collected for this study include:
  • A fragment of the previously operated primary tumor: FFIP block and/or archived frozen tumor if available.

  • A fragment of the liver metastasis(s) performed as part of standard metastasis surgery, this fragment will include a tumor area and a healthy area within the margin of excision. These samples collected in a fresh state will be analyzed immediately.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Analysis of the Impact of 5-Fluorouracil on the Translational Control and Plasticity of Cancer Cells From Liver Metastases of Colon Cancer
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Metastatic colon cancer

Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis.

Procedure: Scheduled and planned surgery
Collection of tumour samples from samples collected as part of standard patient management. Diagnostic pathological analysis will be a priority. These samples will be taken by experienced staff during the hospital visit scheduled as part of standard care.

Outcome Measures

Primary Outcome Measures

  1. 5-FU in ribosome [Up to 24 months]

    Rate of incorporation of 5-fluorouracil into ribosomes of tumor tissues and adjacent healthy tissues before surgery and after surgery.

Secondary Outcome Measures

  1. Methylation profile of ribosomal RNAs [Up to 24 months]

    Analyze on a large scale the alterations of the 2'-O-methylation profile of ribosomal RNAs before surgery and after surgery

  2. Transcriptomic and proteomic profile [Up to 24 months]

    Define a transcriptomic and proteomic profile of the collected samples before surgery and after surgery.

  3. Specific molecular signature [Up to 24 months]

    Combination of the number of 5-fluorouracil molecules incorporated per rRNA molecule, the methylation profile and the transcriptomic profile before surgery and after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis.

  • Patient affiliated to social security

Exclusion Criteria:
  • Other pathologies that may interfere with biological evaluation, in particular known hepatic cirrhosis, whatever its origin, other liver overload diseases (hemochromatosis, Wilson's disease), but excluding steatosis (which can be chemo-induced).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Léon Bérard Lyon France 69008

Sponsors and Collaborators

  • Centre Leon Berard

Investigators

  • Principal Investigator: Philippe CASSIER, MD, Centre Leon Berard

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT04274790
Other Study ID Numbers:
  • ET 19-127 FLUORIB
First Posted:
Feb 18, 2020
Last Update Posted:
May 11, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2021