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

NCT ID: NCT02888717

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-28
• Study Completion Date: 2018-11-13

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.

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.

Conditions

Advanced Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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 will be analysis both by histological analysis and OSNA analysis

Group Type: EXPERIMENTAL

'OSNA stadification during surgery'

Intervention Type: 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.

• 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.

Interventions

'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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JAFFRE Isabelle, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

ICO René Gauducheau

Saint-Herblain, , France

Countries

France

Other Identifiers

ICO-N-2014-06

Identifier Type: -

Identifier Source: org_study_id