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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSNA stadification during surgery | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 'OSNA stadification during surgery' | Procedure | 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.
After the analysis, the report indicates whether the node is:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| 15 days between surgery and OSNA results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JAFFRE Isabelle, MD | Institut de Cancérologie de l'Ouest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO René Gauducheau | Saint-Herblain | 44805 | France |
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