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Trial record 12 of 2271 for:    colon cancer

Butyrophilins Role in Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185272
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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

Condition or disease Intervention/treatment Phase
Colonic Cancer Biological: analysis of BTN and BTNL status Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Role of Butyrophilins in Colon Cancers Aggressiveness Evaluation
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2028

Arm Intervention/treatment
Experimental: non-metastatic colon cancer Biological: analysis of BTN and BTNL status
analysis of BTN and BTNL expression in colon cancer and hepatic metastasis

Experimental: metastatic colon cancer Biological: analysis of BTN and BTNL status
analysis of BTN and BTNL expression in colon cancer and hepatic metastasis




Primary Outcome Measures :
  1. evaluation of BTNL3, BTNL8 and BTNL9 expression by transcriptomics and immunohistochemistry [ Time Frame: 8 years ]
    healthy and cancerous colon ad metastasis (if applicable) will be analysed by



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185272


Contacts
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Contact: Dominique Genre, Dr 04 91 22 37 78 drci.up@ipc.unicancer.fr

Sponsors and Collaborators
Institut Paoli-Calmettes

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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT04185272    
Other Study ID Numbers: IMMUNOCOL-IPC 2019-018
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases