Ovarian Cancer With Peritoneal CarcinosisCARPEMANNCT02493972
Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis
A study testing GelPort and laparotomy in people with Ovarian Cancer With Peritoneal Carcinosis, run by Centre Francois Baclesse at 5 sites in France.
Trial summary
This is a Multicenter prospective diagnostic study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer With Peritoneal Carcinosis
- What is being tested?
- GelPort and laparotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2015to Jul 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age Patient
- Woman presenting a peritoneal carcinosis presumed ovarian origin
- Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available.
- WHO 0 - 2
- Membership in a social security system
- Patient having given her written consent
Who cannot join
- Male
- Contraindication in the coelioscopy
- Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study
- Patient deprived of freedom, under guardianship or guardianship
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU
Amiens
Centre Françis Baclesse
Caen
CHU
Caen
Institut de Cancérologie de l'Ouest
Nantes
Centre Henri Becquerel
Rouen
About this study
This is a Multicenter prospective diagnostic study.
- Being tested
- GelPort, laparotomy
- Keywords
- ovarian cancer, peritoneal carcinosis, manual exploration, surgery, GelPort
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelPortProcedure or surgery
Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability
laparotomyProcedure or surgery
laparotomy will be performed if indication confirmed by manual exploration
| Study group | Role | What they receive |
|---|---|---|
| manual exploration by GelPort | Experimental | manual exploration in supplement of coelioscopy before laparotomy Receives: Procedure: GelPort; Procedure: laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration
Measured: 1 month after inclusion
Secondary outcomes (2)
Number of patients with complications (eventrations, infections, pains) after manual exploration
Measured: 1 month after inclusion
Number of patients with parietal metastases
Measured: 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer With Peritoneal CarcinosisStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493972
- Sponsor's protocol ID
- 2015-A00615-44
- Acronym
- CARPEMAN
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2015
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis
- ClinicalTrials.gov ID
- NCT02493972
- Acronym / sponsor ID
- CARPEMAN / 2015-A00615-44
- Keywords
- ovarian cancer, peritoneal carcinosis, manual exploration, surgery, GelPort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 10 Jul 2015 (estimated)
- 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.
This is a Multicenter prospective diagnostic study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| manual exploration by GelPort | Experimental | Procedure: GelPort, Procedure: laparotomymanual exploration in supplement of coelioscopy before laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years of age Patient
- Woman presenting a peritoneal carcinosis presumed ovarian origin
- Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available.
- WHO 0 - 2
- Membership in a social security system
Key exclusion criteria (4 listed)
- Male
- Contraindication in the coelioscopy
- Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study
- Patient deprived of freedom, under guardianship or guardianship
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 |
|---|---|---|
| GelPortManual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability | Procedure or surgery | manual exploration by GelPort |
| laparotomylaparotomy will be performed if indication confirmed by manual exploration | Procedure or surgery | manual exploration by GelPort |
Primary outcome
evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration
Time frame: 1 month after inclusion
2 secondary outcomes
Number of patients with complications (eventrations, infections, pains) after manual exploration
Time frame: 1 month after inclusion
Number of patients with parietal metastases
Time frame: 1 month after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GelPort and laparotomy in people with Ovarian Cancer With Peritoneal Carcinosis, run by Centre Francois Baclesse at 5 sites 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration (time frame: 1 month after inclusion). 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 9 Jul 2019.