Advanced Cervical Cancer Clinical Trial
Official title:
Concordance Study of Molecular Biology Analysis for Para-aortic Nodes in the Ultra-staging of Advanced Cervical Cancers (GYNOSNA)
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:
- better than the usual histological staging method
- and equivalence in terms of sensitivity and specificity compared to intensive
histological method To complete this study we propose to search the initial brain tumor
expression of cytokeratin 19.
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