PROgastrine COlon DEpistage

January 12, 2022 updated by: ECS-Progastrin SA

Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening

Dosage of progastrin in asymptomatic person participating in colon cancer screening

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • MC
      • Montpellier, MC, France, 34070 MONTPELLIER
        • Centre Hospitalier Princesse Grace, Monaco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progastrin rate
Time Frame: from 15 days to 2 months (until results are obtained)
measuring the rate of progastrin in the blood
from 15 days to 2 months (until results are obtained)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECS-Progastrin SA

Collaborators

Centre Hospitalier Princesse Grace

Investigators

  • Principal Investigator: Georges GARNIER, Centre Hospitalier Princesse Grace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 7, 2019

Primary Completion (ACTUAL)

February 5, 2021

Study Completion (ACTUAL)

December 17, 2021

Study Registration Dates

First Submitted

December 7, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (ACTUAL)

December 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROCODE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Monocentric study; No IPD sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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