Service de chirurgie et oncologie gynécologique et mammaire
Paris, Île-de-France Region, 75013, France
NCT Number: NCT03776630
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).
This study is active but is not currently recruiting participants.
18 year and older
Female
Interventional
Not applicable
Paris, Île-de-France Region, 75013, France
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For all patients (EC, OC, Control)
EC patients
OC patients
Control patients - Any lesion which is supposed to be benign and requires surgery. -
Exclusion criteria
For all patients (OC, EC, Control)
Control patients:
EC patients
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.
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.
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).
Time frame: 2 months
Histopathological characteristics of the tumor in the context of EC: grade
Time frame: 2 months
Histopathological characteristics of the tumor in the context of EC: type endometrioid vs. non endometrioid
Time frame: 60 months
PFS for both 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
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).
Assistance Publique - Hôpitaux de Paris
Other
Acronym: GYNO-MIR
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