Status:
ACTIVE_NOT_RECRUITING
Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Ovarian Cancer
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This trial is a non-randomized, open label and multicenter study. It aims to : for endometrial cancer.:validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk o...
Detailed Description
MicroRNAs (miRs) have been linked to carcinogenesis and can act as metastatic activators or suppressors. There is now ample evidence that circulating miRs can be used as biomarkers. This project is fo...
Eligibility Criteria
Inclusion
- For all patients (EC, OC, Control)
- Written informed consent;
- Age ≥ 18 years old;
- Patient affiliated to social security.
- EC patients
- Histologically proven EC ;
- Type 1 and 2 EC;
- FIGO stage I or II or III EC requiring first intention surgical staging.
- OC patients
- Histologically proven OC or strong suspicion of OC on clinical arguments (abdomino-pelvian mass detected by palpation or echography and/or ascitis and/or elevated CA125);
- Epithelial OC: any histological subtype;
- FIGO stage I to IV OC.
- Control patients - Any lesion which is supposed to be benign and requires surgery. -
Exclusion
- For all patients (OC, EC, Control)
- Unable or unwilling to comply with the protocol requirements and/or unwilling to sign an informed consent form.
- Deprived of liberty or under legal protection measure;
- Ongoing pregnancy;
- Control patients:
- \- Previous history of cancer.
- EC patients
- FIGO stage IV at preoperative imaging techniques.
- Previous history of cancer. OC patients
- Non epithelial cancer.
- Previous history of cancer - except for patients who developed breast cancer at least 5 years or more before ovarian cancer.
Key Trial Info
Start Date :
May 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2027
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT03776630
Start Date
May 23 2019
End Date
May 1 2027
Last Update
August 12 2025
Active Locations (1)
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1
Service de chirurgie et oncologie gynécologique et mammaire
Paris, Île-de-France Region, France, 75013