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

NCT04274790 | Withdrawn

• 1 other identifier: ET 19-127 FLUORIB
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer of Colon; Metastasis to Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Methylation profile of ribosomal RNAs

  Up to 24 months

• Transcriptomic and proteomic profile

  Up to 24 months

• Specific molecular signature

  Up to 24 months

Study Arms (1)

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

Interventions

Scheduled and planned surgery PROCEDURE

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.

Metastatic colon cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with metastatic colon cancer in the hepatic phase.

You may qualify if:

• Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis.
• Patient affiliated to social security

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

* A fragment of the previously operated primary tumor: block and/or archived frozen tumor if available. * A fragment of the liver metastasis.

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Appointments and Schedules

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Philippe CASSIER, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 18, 2020
• Study Start: June 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

FR (1)