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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening
- ClinicalTrials.gov ID
- NCT03775473
- Acronym / sponsor ID
- PROCODE
- Conditions
- Colon Cancer Screening, Healthy Person
- Keywords
- progastrin, screening, bio-marker, healthy person, early stage
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 260 participants (actual)
- Lead sponsor
- ECS-Progastrin SAIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Princesse Grace
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional Research, at Risk and Minimal Constraints, Category 2
| Arm | Type | Receives |
|---|---|---|
| progastrin | Other | Diagnostic Test: progastrinanyone who will participate in colon screening at the Princess Grace Hospital in Monaco and who has signed the informed consent document |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participant in colon cancer screening
- signing informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progastrinPROCODE 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. | Diagnostic test | progastrin |
Primary outcome
progastrin rate
Time frame: from 15 days to 2 months (until results are obtained)
measuring the rate of progastrin in the blood
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No. Monocentric study; No IPD sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges GARNIER principal investigator
Centre Hospitalier Princesse Grace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progastrin in people with Colon Cancer Screening and Healthy Person, run by ECS-Progastrin SA at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progastrin rate (time frame: from 15 days to 2 months (until results are obtained)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.