Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors (GYNO-MIR)

Assistance Publique - Hôpitaux de Paris

Status: Active, not recruiting

Conditions: Endometrial Cancer; Ovarian Cancer

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT03776630

K160922J

2018-A00018-47 (Other Identifier)

Details and patient eligibility

About

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).

Full 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 focused on ovarian (OC) and endometrial cancers (EC), respectively the deadliest and most frequent gynecologic malignancies.

The main challenge for physicians managing women with early-stage EC is when to opt for lymphadenectomy. Tools that are currently used are not accurate enough to identify women with increased risk of nodal metastases. Ballester's team recently found a relationship between the high expression of a set of 5 miRs in the primary tumor and nodal status.

OC is the leading cause of death from gynecological cancer. The prognosis depends on the response of the residual tumor mass to adjuvant chemotherapy. Currently, this response remains largely unpredictable and even difficult to monitor with CA125 measurements and current imaging techniques. Busson's team recently showed that the variation of plasma miR200b during primary treatment is predictive of progression-free survival (PFS).

The study involves 3 populations of participants :

• Patients with EC
• Patients with OC
• Patients undergoing surgery for benign pelvic lesions (control population)

Enrollment: 363 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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363 participants in 3 patient groups

Control

Other group

Description:

Patients undergoing surgery for benign pelvic lesions

Treatment:

Other: Blood sample

Ovarian Cancer

Other group

Treatment:

Other: Blood sample

Endometrial Cancer

Other group

Treatment:

Other: Blood sample