NCT04604613

Prediction of Recurrence Among Low Risk Endometrial Cancer Patients

Prediction of Recurrence Among Low Risk Endometrial Cancer Population

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 518 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This study investigates whether molecular testing can help to predict the risk of endometrial cancer coming back (recurrence) after treatment in patients diagnosed with low risk endometrial cancer and scheduled to have surgery to remove the uterus and/or cervix (hysterectomy). Having sentinel lymph node mapping performed may help researchers to see if the cancer has spread in patients with low risk endometrial cancer.

Detailed description

PRIMARY OBJECTIVE: I. Validate the use of a molecular panel of estrogen-induced genes to predict recurrence in low risk endometrial cancer. SECONDARY OBJECTIVES: I. Calculate the positive predictive value (PPV)/negative predictive value (NPV)/sensitivity (Sens)/specificity (Spec) of lymph node mapping to predict pelvic lymph node involvement. II. Correlate CA125 and HE4 levels with recurrence and to explore the use of other serum biomarkers to predict recurrence. III. Describe patterns of recurrence in a low risk patient population. IV. Determine if molecular panel can predict lymph node involvement in low risk endometrial cancer patients who undergo pelvic and para-aortic lymphadenectomy. V. Compare performance of molecular panel to the Mayo low risk criteria for prediction of lymph node involvement. VI. Compare performance of molecular panel to the high intermediate risk criteria from Gynecologic Oncology Group, trial 99 (GOG 99) for prediction of recurrence. VII. Determine the feasibility of lymph node mapping in this patient population. VIII. Determine the morbidity and mortality of lymph node dissection and mapping. OUTLINE: Patients undergo hysterectomy and sentinel lymph node mapping. Patients may also undergo bilateral salpingo-oophorectomy at the direction of the treating physician. If peritoneal disease or other contraindications to lymphatic mapping are detected at the time of surgery, mapping and sentinel node biopsy are performed at the surgeon's discretion. At the time of hysterectomy, patients undergo collection of tissue for molecular testing. Before and after surgery, patients also undergo collection of blood samples for tumor marker analysis.

Conditions

• FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
• FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Bilateral Salpingectomy with Oophorectomy	Undergo standard of care bilateral salpingo-oophorectomy
PROCEDURE	Biospecimen Collection	Undergo collection of blood and tissue samples
PROCEDURE	Hysterectomy	Undergo standard of care hysterectomy
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Lymph Node Mapping	Undergo sentinel lymph node mapping
PROCEDURE	Sentinel Lymph Node Biopsy	Undergo sentinel lymph node biopsy

Timeline

• Start date: 2012-11-08
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-10-27
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States