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

Cancer of Colon Clinical Trial

— FLUORIB  

Official title:

Analysis of the Impact of 5-Fluorouracil on the Translational Control and Plasticity of Cancer Cells From Liver Metastases of Colon Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04274790
• Other study ID #: ET 19-127 FLUORIB
• Status: Withdrawn
• Start date: June 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2024
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer of Colon
• Colonic Neoplasms
• Metastasis to Liver
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-FU in ribosome	Rate of incorporation of 5-fluorouracil into ribosomes of tumor tissues and adjacent healthy tissues before surgery and after surgery.	Up to 24 months
Secondary	Methylation profile of ribosomal RNAs	Analyze on a large scale the alterations of the 2'-O-methylation profile of ribosomal RNAs before surgery and after surgery	Up to 24 months
Secondary	Transcriptomic and proteomic profile	Define a transcriptomic and proteomic profile of the collected samples before surgery and after surgery.	Up to 24 months
Secondary	Specific molecular signature	Combination of the number of 5-fluorouracil molecules incorporated per rRNA molecule, the methylation profile and the transcriptomic profile before surgery and after surgery.	Up to 24 months