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NCT Number: NCT03622983

Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHI Creteil, Créteil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Refusal of the patient;
  • Non-affiliation to the general social security scheme.

Treatment and study plan

collection of sample and data

Other

Recovery of surgical waste during surgery planned in the current care and clinical data collection

Primary outcomes

  1. circulating tumor and DNA

    Time frame: 2 years

  2. Endometriosis tumor and DNA

    Time frame: 2 years

Secondary outcomes

  1. circulating tumor DNA

    Time frame: 5 years

  2. circulating tumor DNA

    Time frame: 10 years

  3. circulating Micro RNA

    Time frame: 2 years

  4. circulating Micro RNA

    Time frame: 5 years

  5. circulating Micro RNA

    Time frame: 10 years

  6. circulating cytokines

    Time frame: 2 years

  7. circulating cytokines

    Time frame: 5 years

  8. circulating cytokines

    Time frame: 10 years

  9. Tumoral DNA

    Time frame: day of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Cyril Touboul

CONTACT

[email protected]

0156017000 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: PELVIMASS2

Important dates

Study start
2017
Primary completion
2027
Study completion
2037
First posted
Aug 9, 2018
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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