An interventional study of 'OSNA stadification during surgery' in Advanced Cervical Cancer, sponsored by Institut Cancerologie de l'Ouest. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by Institut Cancerologie de l'Ouest · Not applicable, Interventional, and Other
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.
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.
The analysis protocol of a concordance study is the same regardless of the location of the cancer. We evaluate the use of OSNA in order to ultrastaging of lymph node involvement for patients with advanced cancer of the cervix.
Our hypothesis is that OSNA would be:
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This study's enrollment of 16 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
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Exclusion Criteria:
The para-aortic dissection surgery is performed in the usual way. The lymph nodes are isolated from fat tissue during surgery, and will be analysis both by histological analysis and OSNA analysis
Procedure: 'OSNA stadification during surgery'
The para-aortic dissection surgery is performed in the usual way. The lymph nodes are isolated from fat tissue during surgery, and cut into 4 slices sterile. * Slices A and C are sent OSNA analysis * Slices B and D are sent ultimately histological analysis (1 cup HES or 5 cup HES + IHC) The nodes of less than 5 mm will be sent in final histological analysis due to the inability to cut into 4. After the analysis, the report indicates whether the node is: * Free (-): \<250 copies * Micrometastatic (+): 250 ≤ - \<5,000 copies, * Macrometastatic (++): ≥ 5000 copies.
compare the performance of OSNA for the detection of lymph node metastases in advanced cervical cancer
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.
Time frame: 15 days between surgery and OSNA results
Plan to share: No
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Institut Cancerologie de l'Ouest