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NCT02888717: GYNOSNA
Molecular Biology Analysis for Para-aortic Nodes in the Ultra-staging of Advanced Cervical Cancers
NA trial testing 'OSNA stadification during surgery' in Advanced Cervical Cancer in 16 participants. Completed in 13 November 2018.
13 November 2018
Quick facts
| Lead sponsor | Institut Cancerologie de l'Ouest |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 16 |
| Start date | 28 April 2015 |
| Primary completion | 13 November 2018 |
| Estimated completion | 13 November 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- 'OSNA stadification during surgery'
Conditions studied
- Advanced Cervical Cancer — all drugs for Advanced Cervical Cancer →
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.
Verify or expand the search:
- PubMed search for NCT02888717
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02888717 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut Cancerologie de l'Ouest
- Last refreshed: 24 March 2020
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing