Clinical trial · Interventional
Molecular Biology Analysis for Para-aortic Nodes in the Ultra-staging of Advanced Cervical Cancers
Concordance Study of Molecular Biology Analysis for Para-aortic Nodes in the Ultra-staging of Advanced Cervical Cancers (GYNOSNA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 'OSNA stadification during surgery' | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OSNA stadification during surgery
- description
- 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
- interventionNames
- Procedure: 'OSNA stadification during surgery'
Primary outcomes (1)
- measure
- compare the performance of OSNA for the detection of lymph node metastases in advanced cervical cancer
- timeFrame
- 15 days between surgery and OSNA results
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available