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NCT02888717: GYNOSNA

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

Completed NA Last updated 24 March 2020
What this trial tests

NA trial testing 'OSNA stadification during surgery' in Advanced Cervical Cancer in 16 participants. Completed in 13 November 2018.

Timeline
28 April 2015
Primary endpoint
13 November 2018
13 November 2018

Quick facts

Lead sponsorInstitut Cancerologie de l'Ouest
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment16
Start date28 April 2015
Primary completion13 November 2018
Estimated completion13 November 2018
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Institut Cancerologie de l'Ouest — full company profile →

Who can join

18 and older, female only, with Advanced Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02888717.

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