Molecular Biology Analysis for Para-aortic Nodes in the Ultra-staging of Advanced Cervical Cancers

Advanced Cervical Cancer Clinical Trial

— GYNOSNA  

Official title:

Concordance Study of Molecular Biology Analysis for Para-aortic Nodes in the Ultra-staging of Advanced Cervical Cancers (GYNOSNA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888717
• Other study ID #: ICO-N-2014-06
• Status: Completed
• Phase: N/A
• Start date: April 28, 2015
• Est. completion date: November 13, 2018

Study information

• Verified date: March 2020
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 13, 2018
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women aged 18 or over

2. Cervical cancer of any histological type

3. Cervical cancer of advanced stage (>= IB2)

4. negative para-aortic routine PET CT scan

5. Patient affiliated to a social protection scheme

6. Information on the study delivered to the patient

Exclusion Criteria:

1. Patients minor

2. Patient pregnant or breastfeeding or of childbearing age without effective contraception

3. 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

4. Legal incapacity or limited legal capacity. medical or psychological conditions not allowing the subject to understand the study and sign the consent

Related Conditions & MeSH terms

• Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	ICO René Gauducheau	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 days between surgery and OSNA results