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NCT03776630Active, not recruiting

Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors

Source: ClinicalTrials.gov · Last updated 12 Aug 2025

Brief summary (registry, in English)

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 of lymph node metastases for ovarian cancer : to validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (the investigators mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
363 (actual)
First submitted
24 Sept 2018
Start date
23 May 2019
Primary completion date
18 May 2024
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT03776630

What you commit to

  • Study type: Interventional
  • Participants enrolled: 363
  • From 23 May 2019 to the primary completion date, 18 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Ongoing pregnancy;
    • Control patients:
    • \- Previous history of cancer.
    • EC patients
  • 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.

Other

  • 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;
  • FIGO stage IV at preoperative imaging techniques.

Who the study is looking for

  • 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. -

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Service de chirurgie et oncologie gynécologique et mammaire
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.