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

Withdrawn

• Conditions: Cancer of Colon; Metastasis to Liver
• Interventions: Procedure: Scheduled and planned surgery

• Registration Number: NCT04274790
• Lead Sponsor: Centre Leon Berard

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-18
• Study Start: 2021-06-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic colon cancer	Scheduled and planned surgery	Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
Transcriptomic and proteomic profile	Up to 24 months	Define a transcriptomic and proteomic profile of the collected samples before surgery and after surgery.

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon, France