Brief Title
Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors
Official Title
Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors
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 Type
Interventional
Primary Outcome
For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).
Secondary Outcome
It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC.
Condition
Ovarian Cancer
Intervention
Blood sample
Study Arms / Comparison Groups
Control
Description: Patients undergoing surgery for benign pelvic lesions
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
363
Start Date
May 23, 2019
Completion Date
May 2027
Primary Completion Date
May 2023
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Geoffroy CANLORBE, Doctor, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03776630
Organization ID
K160922J
Secondary IDs
2018-A00018-47
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor
Geoffroy CANLORBE, Doctor, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
June 2022