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

June 29, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

363

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75013
        • Service de chirurgie et oncologie gynécologique et mammaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Patients undergoing surgery for benign pelvic lesions
Other: Blood sample

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.
Other: Ovarian Cancer
Other: Blood sample

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.
Other: Endometrial Cancer
Other: Blood sample

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).
Time Frame: 2 months
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.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC.
Time Frame: 2 months
Histopathological characteristics of the tumor in the context of EC: grade
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)
Time Frame: 2 months
Histopathological characteristics of the tumor in the context of EC: type endometrioid vs. non endometrioid
2 months
It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of PFS in EC and OC
Time Frame: 60 months
PFS for both 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
Time Frame: 60 months
OS (defined as the time from the start of the treatment to death) for both EC and OC
60 months
Sensitivity and specificity of plasma miR detection by RCA-FRET applied directly on plasma samples or following RNA extraction.
Time Frame: 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).
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Geoffroy CANLORBE, Doctor, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2019

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2027

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

December 12, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K160922J
  • 2018-A00018-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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