Pelvic NeoplasmsPELVIMASS2NCT03622983
Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization
An observational study of Pelvic Neoplasms and Endometriosis, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial summary
The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Neoplasms, Endometriosis
- What is being tested?
- collection of sample and data
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- 1 May 2017to Aug 2037
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients with pelvic gynecological cancer or with endometriosis
Who may be able to join
- Diagnosis of pelvic gynecological cancer posed on initial histological analysis or during recurrence;
- Or diagnosis of endometriosis on histology or imaging
- Age ≥ 18 years;
- Affiliation to the general social security scheme;
- Consent signed.
Who cannot join
- Refusal of the patient;
- Non-affiliation to the general social security scheme.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHI Creteil
Créteil, 94000
Gregoire Miailhe, MD, Gregoire.Miailhe@chicreteil.fr
- Recruiting
CHU Tenon
Paris, 75000
Cyril Touboul, cyril.touboul@gmail.com
About this study
The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing ovarian tumors can select patients who can benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. The results obtained are very promising. This study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.
Read the detailed description
The management of pelvic gynecological cancers (PGC) is based on the determination of the extension in order to guide the treatments. The biology of PGC is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing of ovarian tumors allows selection of patients who may benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify factors that predict recurrence of these cancers. The results have obtained are very promising, but if coordinator team have at our disposal fundamental and translational data related to the prognosis of PGCs, the coordinator team lack access to a biological collection of these cancers that would allow us to test our hypotheses and to develop personalized medicine related to the clinico-biological characteristics of the patients.
Endometriosis is the 1st cause of chronic pelvic pain (25-40% of women suffering during sexual intercourse) and represents the 1st cause of school and work absenteeism. Unfortunately, it is under-diagnosed and too often inappropriately managed. It is considered that 10 to 15% of the female population of reproductive age has endometriosis. This incidence reaches 50% in women with infertility. There are many similarities between deep endometriosis and pelvic cancers, whether on a physiopathological, epidemiological or clinical level. There are therefore many similarities in the surgical management as well as in the research strategies.
- Conditions
- Pelvic Neoplasms, Endometriosis
- Being tested
- collection of sample and data
- Medical subject headings
- Pelvic Neoplasms, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of sample and dataOther
Recovery of surgical waste during surgery planned in the current care and clinical data collection
| Study group | Role | What they receive |
|---|---|---|
| Collection of sample and data | Collection of biological samples and clinical data Receives: Other: collection of sample and data |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating tumor and DNA
Measured: 2 years
Endometriosis tumor and DNA
Measured: 2 years
Secondary outcomes (9)
circulating tumor DNA
Measured: 5 years
circulating tumor DNA
Measured: 10 years
circulating Micro RNA
Measured: 2 years
circulating Micro RNA
Measured: 5 years
circulating Micro RNA
Measured: 10 years
circulating cytokines
Measured: 2 years
circulating cytokines
Measured: 5 years
circulating cytokines
Measured: 10 years
Tumoral DNA
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 May 2017
- Primary completionAug 2027 (estimated)
- Study completionAug 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622983
- Sponsor's protocol ID
- PELVIMASS2
- Other IDs
- 2016-A00613-48
- Acronym
- PELVIMASS2
- Status last verified
- Dec 2022
- First submitted
- 1 Aug 2018
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization
- ClinicalTrials.gov ID
- NCT03622983
- Acronym / sponsor ID
- PELVIMASS2 / PELVIMASS2
- Conditions
- Pelvic Neoplasms, Endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2037 (estimated)
- First posted
- 9 Aug 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.
The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing ovarian tumors can select patients who can benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. The results obtained are very promising. This study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.
Detailed description
The management of pelvic gynecological cancers (PGC) is based on the determination of the extension in order to guide the treatments. The biology of PGC is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing of ovarian tumors allows selection of patients who may benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify factors that predict recurrence of these cancers. The results have obtained are very promising, but if coordinator team have at our disposal fundamental and translational data related to the prognosis of PGCs, the coordinator team lack access to a biological collection of these cancers that would allow us to test our hypotheses and to develop personalized medicine related to the clinico-biological characteristics of the patients.
Endometriosis is the 1st cause of chronic pelvic pain (25-40% of women suffering during sexual intercourse) and represents the 1st cause of school and work absenteeism. Unfortunately, it is under-diagnosed and too often inappropriately managed. It is considered that 10 to 15% of the female population of reproductive age has endometriosis. This incidence reaches 50% in women with infertility. There are many similarities between deep endometriosis and pelvic cancers, whether on a physiopathological, epidemiological or clinical level. There are therefore many similarities in the surgical management as well as in the research strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collection of sample and data | – | Other: collection of sample and dataCollection of biological samples and clinical data |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with pelvic gynecological cancer or with endometriosis
Key inclusion criteria (5 listed)
- Diagnosis of pelvic gynecological cancer posed on initial histological analysis or during recurrence;
- Or diagnosis of endometriosis on histology or imaging
- Age ≥ 18 years;
- Affiliation to the general social security scheme;
- Consent signed.
Key exclusion criteria (2 listed)
- Refusal of the patient;
- Non-affiliation to the general social security scheme.
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 |
|---|---|---|
| collection of sample and dataRecovery of surgical waste during surgery planned in the current care and clinical data collection | Other | Collection of sample and data |
Primary outcome
circulating tumor and DNA
Time frame: 2 years
Endometriosis tumor and DNA
Time frame: 2 years
9 secondary outcomes
circulating tumor DNA
Time frame: 5 years
circulating tumor DNA
Time frame: 10 years
circulating Micro RNA
Time frame: 2 years
circulating Micro RNA
Time frame: 5 years
circulating Micro RNA
Time frame: 10 years
circulating cytokines
Time frame: 2 years
circulating cytokines
Time frame: 5 years
circulating cytokines
Time frame: 10 years
Tumoral DNA
Time frame: day of surgery
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 21 Dec 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Neoplasms and Endometriosis, run by Centre Hospitalier Intercommunal Creteil at 2 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 5 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: looking for participants now, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Cyril Touboul (0156017000 ext. +33, cyril.touboul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating tumor and DNA (time frame: 2 years). The study lists 2 primary outcomes in all. 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 21 Dec 2022.