One-step nucleic acid amplification versus ultra-staging to detect sentinel lymph node metastasis in endometrial cancer: a randomized, multi-center, controlled trial (SENT-OSNA Trial).

BACKGROUND

Sentinel lymph node (SLN) biopsy is the standard of care in apparent early-stage endometrial cancer. However, ultra-staging protocols have not been standardized, which may contribute to variability in the detection of SLN metastases. The one-step nucleic acid amplification (OSNA) method has been proposed as a rapid and standardized technique to diagnose SLN metastasis.

PRIMARY

OBJECTIVE

To compare the ability to detect SLN metastasis between OSNA and ultra-staging.

STUDY HYPOTHESIS: OSNA is non-inferior to ultra-staging in detecting lymph node metastases.

TRIAL

DESIGN

This is a prospective, multi-center, randomized, non-inferiority trial.

MAJOR INCLUSION/EXCLUSION CRITERIA: The trial includes patients with histologically confirmed endometrial cancer and apparent (pre-operative) uterine-confined tumor, who are undergoing an attempt at SLN mapping. Exclusion criteria are uterine sarcoma (except for carcinosarcomas), de-differentiated or un-differentiated histology, fertility-sparing management, neoadjuvant therapy, previous surgery to pelvic lymph nodes, and suspicious lymph nodes on pre-operative imaging.

PRIMARY ENDPOINT: Incidence of SLN metastasis in the OSNA group versus the ultra-staging group.

SAMPLE SIZE: Assuming a maximum allowable difference of -4% in the proportion of patients with detected lymph node metastases (node-positive proportion) to declare non-inferiority, a power of 80%, and a significance level of 2.5% (one side), a sample size of 1922 (961 per arm) is needed.

ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING

RESULTS

Four years of accrual, with estimated results to be presented in 2029.

TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (NCT06935305).