NCT03775473

Brief Summary

Dosage of progastrin in asymptomatic person participating in colon cancer screening

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

December 7, 2018

Last Update Submit

January 12, 2022

Conditions

Colon Cancer ScreeningHealthy Person

Keywords

progastrinscreeningbio-markerhealthy personearly stage

Outcome Measures

Primary Outcomes (1)

  • progastrin rate

    measuring the rate of progastrin in the blood

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

Study Arms (1)

progastrin

OTHER

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

Interventions

progastrinDIAGNOSTIC_TEST

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.

progastrin

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participant in colon cancer screening
  • signing informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Princesse Grace, Monaco

Montpellier, MC, 34070 MONTPELLIER, France

Location

Study Officials

  • Georges GARNIER

    Centre Hospitalier Princesse Grace

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Interventional Research, at Risk and Minimal Constraints, Category 2
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2018

First Posted

December 14, 2018

Study Start

February 7, 2019

Primary Completion

February 5, 2021

Study Completion

December 17, 2021

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Monocentric study; No IPD sharing

Locations

FR(1)