Butyrophilins Role in Colon Cancer

NCT04185272 | Recruiting

• 1 other identifier: IMMUNOCOL-IPC 2019-018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

quantification of BTNL molecules in colon cancer in order to determinate if their could be used as a prognostic marquer

Conditions

Colonic Cancer

Outcome Measures

Primary Outcomes (1)

• evaluation of BTNL3, BTNL8 and BTNL9 expression by transcriptomics and immunohistochemistry

  healthy and cancerous colon ad metastasis (if applicable) will be analysed by

  8 years

Study Arms (2)

non-metastatic colon cancer

EXPERIMENTAL

Biological: analysis of BTN and BTNL status

metastatic colon cancer

EXPERIMENTAL

Biological: analysis of BTN and BTNL status

Interventions

analysis of BTN and BTNL status BIOLOGICAL

analysis of BTN and BTNL expression in colon cancer and hepatic metastasis

metastatic colon cancer; non-metastatic colon cancer

Eligibility Criteria

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

You may qualify if:

• Patient is older than 18 years old,
• Signed participation consent,
• Non-metastatic colon cancer immediately resectable or metastatic and liver synchronous for which it was decided a combined colic and liver surgery (metastatic patient at the outset) in multidisciplinary consultation meeting.
• Performance Status (PS) 0 or 1
• affiliated to the social security or beneficiary

You may not qualify if:

• Rectal cancer, colon cancer recurrence
• Emergency of colon cancer Surgery
• History of inflammatory disease of the digestive tract (Crohn's disease or ulcerative colitis)
• Patient who received neoadjuvant therapy other than chemotherapy
• Patient treated with immune-suppressors or long-course corticosteroids \<12 months
• Pregnant women or likely to be pregnant (without effective contraception) or breastfeeding,
• Person in urgent situation, person under legal protection measure, or unable to express his / her consent,
• Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13273, France

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

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

Central Study Contacts

Jihane PAKRADOUNI, PharmD,PhD

CONTACT

04 91 22 37 78; drci.up@ipc.unicancer.fr

Laurie-Anne GOUTY, PhD

CONTACT

33491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: colon cancer patients and metastatic colon cancer patients will be included in this study. We expect that BTNL molecules expression is different depending of the aggressiveness of the illness

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: June 30, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)