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

NCT03776630 | Active Not Recruiting

• 2 other identifiers: K160922J2018-A00018-47
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Ovarian Cancer; Endometrial Cancer

Keywords

Ovarian cancer; endometrial cancer; miR; diagnostic

Outcome Measures

Primary Outcomes (2)

• For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).

  To validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases.

  2 months

• For OC: PFS or death for any cause at 24 months.

  To validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (by OC treatment, we mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).

  24 months

Secondary Outcomes (5)

• It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC.

  2 months

• It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC (1)

  2 months

• It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of PFS in EC and OC

  60 months

• It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of OS in EC and OC

  60 months

• Sensitivity and specificity of plasma miR detection by RCA-FRET applied directly on plasma samples or following RNA extraction.

  60 months

Study Arms (3)

Control

OTHER

Patients undergoing surgery for benign pelvic lesions

Other: Blood sample

Ovarian Cancer

OTHER

Other: Blood sample

Endometrial Cancer

OTHER

Other: Blood sample

Interventions

Blood sample OTHER

Two blood samples (2 tubes of 4 ml for each blood sample) will be collected per patient during the study period for EC and OC. One blood sample will be collected for control population. The first sample will be collected prior to any treatment for EC, OC, and control population. For EC, the second collection will be done one month post-surgery. For OC, the second collection will be done 6 to 9 months after the initial diagnosis, in most cases at the completion of adjuvant chemotherapy. For control population, there will be no second sample.

Control; Endometrial Cancer; Ovarian Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Service de chirurgie et oncologie gynécologique et mammaire

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Geoffroy CANLORBE, Doctor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: December 17, 2018
• Study Start: May 23, 2019
• Primary Completion: May 18, 2024
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

FR (1)