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PROgastrine COlon DEpistage

Primary Purpose

Colon Cancer Screening, Healthy Person

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

progastrin

About this trial

This is an interventional diagnostic trial for Colon Cancer Screening focused on measuring progastrin, screening, bio-marker, healthy person, early stage

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Centre Hospitalier Princesse Grace, Monaco

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

progastrin

Arm Description

anyone who will participate in colon screening at the Princess Grace Hospital in Monaco and who has signed the informed consent document

Outcomes

Primary Outcome Measures

progastrin rate

measuring the rate of progastrin in the blood

Secondary Outcome Measures

Full Information

NCT ID

NCT03775473

First Posted

December 7, 2018

Last Updated

January 12, 2022

Sponsor

ECS-Progastrin SA

Collaborators

Centre Hospitalier Princesse Grace

1. Study Identification

Unique Protocol Identification Number

NCT03775473

Brief Title

PROgastrine COlon DEpistage

Official Title

Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

COVID-19 pandemic has made it increasingly difficult for ECS progastrin to ensure clinical research is maintained. As a result, the sponsor made the decision to end patient enrollment prematurely.

Study Start Date

February 7, 2019 (Actual)

Primary Completion Date

February 5, 2021 (Actual)

Study Completion Date

December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ECS-Progastrin SA

Collaborators

Centre Hospitalier Princesse Grace

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Dosage of progastrin in asymptomatic person participating in colon cancer screening

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.

6. Conditions and Keywords

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

Colon Cancer Screening, Healthy Person

Keywords

progastrin, screening, bio-marker, healthy person, early stage

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Interventional Research, at Risk and Minimal Constraints, Category 2

Masking

None (Open Label)

Allocation

N/A

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

progastrin

Arm Type

Other

Arm Description

anyone who will participate in colon screening at the Princess Grace Hospital in Monaco and who has signed the informed consent document

Intervention Type

Diagnostic Test

Intervention Name(s)

progastrin

Intervention Description

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 Measure Information:

Title

progastrin rate

Description

measuring the rate of progastrin in the blood

Time Frame

from 15 days to 2 months (until results are obtained)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Georges GARNIER

Organizational Affiliation

Centre Hospitalier Princesse Grace

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Princesse Grace, Monaco

City

Montpellier

State/Province

ZIP/Postal Code

34070 MONTPELLIER

Country

France

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Monocentric study; No IPD sharing

Learn more about this trial

PROgastrine COlon DEpistage

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