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

NCT02888717 | Completed

• 1 other identifier: ICO-N-2014-06
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Procedure: 'OSNA stadification during surgery'

Interventions

'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. * 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.

OSNA stadification during surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 or over
• Cervical cancer of any histological type
• Cervical cancer of advanced stage (\>= IB2)
• negative para-aortic routine PET CT scan
• Patient affiliated to a social protection scheme
• Information on the study delivered to the patient

You may not qualify if:

• Patients minor
• Patient pregnant or breastfeeding or of childbearing age without effective contraception
• 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
• Legal incapacity or limited legal capacity. medical or psychological conditions not allowing the subject to understand the study and sign the consent

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

ICO René Gauducheau

Saint-Herblain, 44805, France

Location

Study Officials

• JAFFRE Isabelle, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: April 28, 2015
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)