Concordance Study of Molecular Biology Analysis for Para-aortic Nodes in the Ultra-staging of Advanced Cervical Cancers (GYNOSNA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- compare the performance of OSNA for the detection of lymph node metastases in advanced cervical cancer
Study Overview
Brief Summary
The para-aortic lymph node involvement in the advanced stage of cervical cancer is a poor prognostic factor for overall survival. Concomitant chemo-radiotherapy has become the standard treatment for advanced cervical cancer. In case of para-aortic lymph node involvement, an extension of radiotherapy fields is recommended.
A prospective multicentre study shown that the survival rate of patients with node ≤ 5 mm and which benefited from the expansion of radiotherapy fields was identical to the survival of pN0 patients.
However, due to a specific disease, this technique should not be performed in all patients. It is necessary to reliably select patients with retroperitoneal lymph node involvement. For this, it is recommended that prior to the concurrent chemo-radiotherapy, nodal staging surgery with a definitive histological analysis.
So we propose to use molecular diagnostic test OSNA (One Step Nucleic Acid Amplification) to improve lymph node metastasis detection sensitivity to achieve ultra-staging compared to conventional histology.
Detailed Description
The para-aortic lymph node involvement in the advanced stage of cervical cancer is a poor prognostic factor for overall survival. Concomitant chemoradiotherapy has become the standard treatment for advanced cervical cancer. In case of para-aortic lymph node involvement, an extension of radiotherapy fields is recommended.
A prospective multicenter study shown that the survival rate of patients with node ≤ 5 mm and which benefited from the expansion of radiotherapy fields was identical to the survival of pN0 patients.
However, due to a specific disease, this technique should not be performed in all patients. It is necessary to reliably select patients with retroperitoneal lymph node involvement. For this, it is recommended that prior to the concurrent chemoradiotherapy, nodal staging surgery with a definitive histological analysis.
So we suggest using molecular diagnostic test OSNA (One Step Nucleic Acid Amplification) to improve lymph node metastasis detection sensitivity to achieve ultra-staging compared to conventional histology.
We propose to consider a new concordance study to assess the feasibility of the technical OSNA in a new indication: cervical cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged 18 or over
- •Cervical cancer of any histological type
- •Cervical cancer of advanced stage (>= IB2)
- •negative para-aortic routine PET CT scan
- •Patient affiliated to a social protection scheme
- •Information on the study delivered to the patient
Exclusion Criteria
- •Patients minor
- •Patient pregnant or breastfeeding or of childbearing age without effective contraception
- •Other concurrent cancer or history of cancer (in the 5 years preceding the entry into the trial), except in situ cervical cancer treated basal cell or squamous cell or treated carcinoma
- •Legal incapacity or limited legal capacity. medical or psychological conditions not allowing the subject to understand the study and sign the consent
Outcomes
Primary Outcomes
compare the performance of OSNA for the detection of lymph node metastases in advanced cervical cancer
Time Frame: 15 days between surgery and OSNA results
The main objective is to compare the performance of OSNA to both conventional methods and intensive histological analysis, for the detection of lymph node metastases in advanced cervical cancer. The evaluation criteria is : * Determination of number of lymph node metastases expressed in a size in mm for conventional and intensive histological analysis. * Determination of the number of lymph node metastases expressed in a number of copies in molecular biology.
Secondary Outcomes
No secondary outcomes reported