Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
Recruiting
Phase 3
Interventional Study
Ovarian Neoplasms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 200 (estimated)
- Sponsor
- Instituto de Investigacion Sanitaria La Fe · Other
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About This Trial
This clinical trial investigates the sentinel lymph node (SLN) technique as a less invasive alternative to conventional lymphadenectomy in patients with early-stage ovarian cancer. The primary objective is to evaluate the effectiveness, safety, and diagnostic accuracy of the SLN approach in detecting lymphatic metastases. By assessing its negative predictive value, the study aims to determine whet…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed informed consent prior to the performance of any procedure related to the clinical trial.
* Female, 18 years of age or older at the time of inclusion.
* Patients with a histopathological diagnosis of malignant ovarian tumor in a deferred study (any epithelial histology)…
Contacts
Mónica Cebrián Coordinator Clinical Research Area
+34961246731
investigacion_clinica@iislafe.es
CONTACT