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Spots Global Cancer Trial Database for Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors

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Trial Identification

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

Study ID: NCT03776630

Interventions

Blood sample

Study Description

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)

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Geoffroy CANLORBE, Doctor

Affiliation: Assistance Publique - Hôpitaux de Paris

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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