CancerBCBNCT04221464
Development of a Clinical and Biological Database in Peritoneal Carcinosis (BCB CARCINOSE)
A study testing biological collection and Tissues collections in people with Cancer and Peritoneal Carcinosis, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The creation of a prospective clinical-biological base dedicated to peritoneal carcinosis must therefore be able to serve as a support for this essential search for transfer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Peritoneal Carcinosis
- What is being tested?
- biological collection and Tissues collections
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2019to Feb 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over the age of 18;
- Patient managed for peritoneal carcinosis : digestives origins (pancreatic, gastroesophageal junction, colorectal, bowel) or peritoneum cancer
- Patient eligible for a peritoneal carcinosis treatment : at least one (or more) surgery (s) ;chemotherapy or any treatment for this disease
- Patient agree will all study procedure : biological samples \& tissues samples
- Patient giving informed consent
Who cannot join
- Patient not affiliated to Social Protection system
- Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
- The level of French is insufficient to consent to the study and to response to the questionnaires
- Patient under guardianship
- Pregnancy ou breast-feeding women
- Patient treated in case of an emergency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut du cancer de Montpellier ICM
Montpellier, 34298
QUENET François,MD, 0467612354 ext. 33, francois.quenet@icm.unicancer.fr
About this study
Official title: Development of a Clinical and Biological Database Monocentric and Prospective in Peritoneal Carcinosis
The creation of a prospective clinical-biological base dedicated to peritoneal carcinosis must therefore be able to serve as a support for this essential search for transfer.
Read the detailed description
The main objective is to improve the knowledge of carcinosis mechanisms to develop a specific treatment.
That's why this blood collection and tissue collection is very important for the future, these collection will be permitted to the scientists to develop a research specially for carcinosis.
- Conditions
- Cancer, Peritoneal Carcinosis
- Being tested
- biological collection, Tissues collections
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological collectionBiological
Blood samples collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression
Tissues collectionsOther
Tumours and not tumours tissues will be collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression
| Study group | Role | What they receive |
|---|---|---|
| Tumors and blood collection | Experimental | For all the patients include in the study :
* Blood samples will be collected at different times : before any treatment, at every surgery, one month after any surgery, at progression.
* Tumours and not tumours tissues will be collected at different times : Before any surgery, one month after any surgery
In parallel to this biological collection, standardized clinical data will be entered into a database treatment, at every surgery Receives: Biological: biological collection; Other: Tissues collections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who gave their consent to participate in the study
The proportion of patients who consent to participate in the study among the screened patients
Measured: Until the study completion: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start25 Nov 2019
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François QUENET,MD, Study chair, Institut régional du cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221464
- Sponsor's protocol ID
- PROICM 2019-01 BCA
- Acronym
- BCB
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Clinical and Biological Database Monocentric and Prospective in Peritoneal Carcinosis
- ClinicalTrials.gov ID
- NCT04221464
- Acronym / sponsor ID
- BCB / PROICM 2019-01 BCA
- Conditions
- Cancer, Peritoneal Carcinosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2038 (estimated)
- First posted
- 9 Jan 2020 (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.
The creation of a prospective clinical-biological base dedicated to peritoneal carcinosis must therefore be able to serve as a support for this essential search for transfer.
Detailed description
The main objective is to improve the knowledge of carcinosis mechanisms to develop a specific treatment.
That's why this blood collection and tissue collection is very important for the future, these collection will be permitted to the scientists to develop a research specially for carcinosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumors and blood collection | Experimental | Biological: biological collection, Other: Tissues collectionsFor all the patients include in the study : * Blood samples will be collected at different times : before any treatment, at every surgery, one month after any surgery, at progression. * Tumours and not tumours tissues will be collected at different times : Before any surgery, one month after any surgery In parallel to this biological collection, standardized clinical data will be entered into a database treatment, at every surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient over the age of 18;
- Patient managed for peritoneal carcinosis : digestives origins (pancreatic, gastroesophageal junction, colorectal, bowel) or peritoneum cancer
- Patient eligible for a peritoneal carcinosis treatment : at least one (or more) surgery (s) ;chemotherapy or any treatment for this disease
- Patient agree will all study procedure : biological samples \& tissues samples
- Patient giving informed consent
Key exclusion criteria (6 listed)
- Patient not affiliated to Social Protection system
- Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
- The level of French is insufficient to consent to the study and to response to the questionnaires
- Patient under guardianship
- Pregnancy ou breast-feeding women
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 |
|---|---|---|
| biological collectionBlood samples collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression | Biological | Tumors and blood collection |
| Tissues collectionsTumours and not tumours tissues will be collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression | Other | Tumors and blood collection |
Primary outcome
Proportion of patients who gave their consent to participate in the study
Time frame: Until the study completion: 4 years
The proportion of patients who consent to participate in the study among the screened patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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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.
François QUENET,MD study chair
Institut régional du cancer de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological collection and Tissues collections in people with Cancer and Peritoneal Carcinosis, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurore MOUSSION (467613100 ext. 33, aurore.moussion@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who gave their consent to participate in the study (time frame: Until the study completion: 4 years). 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 12 Feb 2025.