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

Not Applicable

Active, not recruiting

• Conditions: Endometrial Cancer; Ovarian Cancer
• Interventions: Other: Blood sample

• Registration Number: NCT03776630
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

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 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)

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-17
• Study Start: 2019-05-23
• Primary Completion: 2024-05-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 363

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ovarian Cancer	Blood sample	-
Control	Blood sample	Patients undergoing surgery for benign pelvic lesions
Endometrial Cancer	Blood sample	-

Primary Outcome Measures

Name	Time	Method
For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).	2 months	To validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases.
For OC: PFS or death for any cause at 24 months.	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).

Secondary Outcome Measures

Name	Time	Method
It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of OS in EC and OC	60 months	OS (defined as the time from the start of the treatment to death) for both EC and OC
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	Histopathological characteristics of the tumor in the context of EC: type endometrioid vs. non endometrioid
It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of PFS in EC and OC	60 months	PFS for both EC and OC
Sensitivity and specificity of plasma miR detection by RCA-FRET applied directly on plasma samples or following RNA extraction.	60 months	it aims to validate multiplexed homogenous miR detection based on RCA-FRET compared to conventional qRT-PCR in plasma samples. It also aims to search for novel plasma miRs potentially informative on lymph node involvement (EC) or PFS (OC) by high throughput sequencing (RNA seq).
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	Histopathological characteristics of the tumor in the context of EC: grade

Trial Locations

Locations (1)

Service de chirurgie et oncologie gynécologique et mammaire; 🇫🇷 Paris, Ile De France, France