Colon Cancer ScreeningNCT03775473
PROgastrine COlon DEpistage
A study testing progastrin in people with Colon Cancer Screening and Healthy Person, run by ECS-Progastrin SA at 1 site in France.
Trial summary
Dosage of progastrin in asymptomatic person participating in colon cancer screening Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer Screening, Healthy Person
- What is being tested?
- progastrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2019to 17 Dec 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participant in colon cancer screening
- signing informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Princesse Grace, Monaco
Montpellier, MC, 34070 MONTPELLIER
About this study
Official title: Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening
Dosage of progastrin in asymptomatic person participating in colon cancer screening
Read the 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.
- Conditions
- Colon Cancer Screening, Healthy Person
- Being tested
- progastrin
- Keywords
- progastrin, screening, bio-marker, healthy person, early stage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| progastrin | Other | anyone who will participate in colon screening at the Princess Grace Hospital in Monaco and who has signed the informed consent document Receives: Diagnostic Test: progastrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progastrin rate
measuring the rate of progastrin in the blood
Measured: from 15 days to 2 months (until results are obtained)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start7 Feb 2019
- Primary completion5 Feb 2021
- Study completion17 Dec 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional Research, at Risk and Minimal Constraints, Category 2
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECS-Progastrin SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Princesse Grace
- Responsible party
- Sponsor
- Investigators
- Georges GARNIER, Principal investigator, Centre Hospitalier Princesse Grace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775473
- Sponsor's protocol ID
- PROCODE
- Status last verified
- Jan 2022
- First submitted
- 7 Dec 2018
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Monocentric study; No IPD sharing