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PROgastrine COlon DEpistage

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: NCT03775473
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Centre Hospitalier Princesse Grace
Information provided by (Responsible Party):
ECS-Progastrin SA

Brief Summary:
Dosage of progastrin in asymptomatic person participating in colon cancer screening

Condition or disease Intervention/treatment Phase
Colon Cancer Screening Healthy Person Diagnostic Test: progastrin Not Applicable

Detailed Description:
For anyone who will participate in colon screening at the Princess Grace Hospital of Monaco and who has signed the informed consent document. A blood test will be performed in addition to the screening test to assess the rate of progastrin.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Interventional Research, at Risk and Minimal Constraints, Category 2
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening
Actual Study Start Date : February 7, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
progastrin
anyone who will participate in colon screening at the Princess Grace Hospital in Monaco and who has signed the informed consent document
Diagnostic Test: progastrin
PROCODE is an interventional study of category 2 (non-medicinal product), with a minimal risks and restrictions, involving only one blood drawn at the screening of colon cancer.




Primary Outcome Measures :
  1. progastrin rate [ Time Frame: from 15 days to 2 months (until results are obtained) ]
    measuring the rate of progastrin in the blood



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • participant in colon cancer screening
  • signing informed consent

Exclusion Criteria:

  • any major medical, psychiatric or addictive illness that would affect the informed consent process
  • The consent of a representative is not allowed in this study

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): NCT03775473


Contacts
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Contact: Georges Pr GARNIER +377 97 98 84 29 recherche.clinique@chpg.mc
Contact: Mélina BLAIRVACQ, Référent 0467798230 m.blairvacq@eurobiodev.com

Locations
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France
Centre Hospitalier Princesse Grace Recruiting
Monaco, MC, France, 98012
Contact: BLAIRVACQ MELINA, ARC    04.67.79.82.30    m.blairvacq@eurobiodev.com   
Sponsors and Collaborators
ECS-Progastrin SA
Centre Hospitalier Princesse Grace
Investigators
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Principal Investigator: Georges GARNIER Centre Hospitalier Princesse Grace
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Responsible Party: ECS-Progastrin SA
ClinicalTrials.gov Identifier: NCT03775473    
Other Study ID Numbers: PROCODE
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Monocentric study; No IPD sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ECS-Progastrin SA:
progastrin
screening
bio-marker
healthy person
early stage
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases