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Butyrophilins Role in Colon Cancer

Primary Purpose

Colonic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
analysis of BTN and BTNL status
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colonic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Lopez AlmeidaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

non-metastatic colon cancer

metastatic colon cancer

Arm Description

Outcomes

Primary Outcome Measures

evaluation of BTNL3, BTNL8 and BTNL9 expression by transcriptomics and immunohistochemistry
healthy and cancerous colon ad metastasis (if applicable) will be analysed by

Secondary Outcome Measures

Full Information

First Posted
December 2, 2019
Last Updated
April 20, 2022
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT04185272
Brief Title
Butyrophilins Role in Colon Cancer
Official Title
Role of Butyrophilins in Colon Cancers Aggressiveness Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
non-metastatic colon cancer
Arm Type
Experimental
Arm Title
metastatic colon cancer
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
analysis of BTN and BTNL status
Intervention Description
analysis of BTN and BTNL expression in colon cancer and hepatic metastasis
Primary Outcome Measure Information:
Title
evaluation of BTNL3, BTNL8 and BTNL9 expression by transcriptomics and immunohistochemistry
Description
healthy and cancerous colon ad metastasis (if applicable) will be analysed by
Time Frame
8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Genre, Dr
Phone
04 91 22 37 78
Email
drci.up@ipc.unicancer.fr
Facility Information:
Facility Name
Lopez Almeida
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonor LOPEZ ALMEIDA
Phone
0491223631
First Name & Middle Initial & Last Name & Degree
Marina LAROSA
Phone
0491223778

12. IPD Sharing Statement

Plan to Share IPD
No

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Butyrophilins Role in Colon Cancer

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