Prediction of Recurrence Among Low Risk Endometrial Cancer Patients

NCT04604613 | Active Not Recruiting

• 2 other identifiers: PA12-0550NCI-2020-07548
• Study Type: observational
• Target: 518
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma; FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence

  Will validate a model's ability to predict 2-year recurrence in low-risk endometrial cancer patients.

  At 2 years

Secondary Outcomes (6)

• Predictive ability of lymph node mapping in pelvic lymph node involvement

  Up to 2 years

• Feasibility of lymph node mapping

  Up to 2 years

• Morbidity and mortality prevalence associated with lymph node dissection

  Up to 2 years

• Patterns of recurrence

  Up to 2 years

• Predictive ability of molecular panel in lymph node involvement

  Up to 2 years

Study Arms (1)

Ancillary-Correlative (biospecimen collection, node mapping)

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.

Procedure: Bilateral Salpingectomy with Oophorectomy; Procedure: Biospecimen Collection; Procedure: Hysterectomy; Other: Laboratory Biomarker Analysis; Procedure: Lymph Node Mapping; Procedure: Sentinel Lymph Node Biopsy

Interventions

Bilateral Salpingectomy with Oophorectomy PROCEDURE

Undergo standard of care bilateral salpingo-oophorectomy

Also known as: bilateral salpingo-oophorectomy

Ancillary-Correlative (biospecimen collection, node mapping)

Biospecimen Collection PROCEDURE

Undergo collection of blood and tissue samples

Ancillary-Correlative (biospecimen collection, node mapping)

Hysterectomy PROCEDURE

Undergo standard of care hysterectomy

Also known as: Hysterectomy NOS

Ancillary-Correlative (biospecimen collection, node mapping)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-Correlative (biospecimen collection, node mapping)

Lymph Node Mapping PROCEDURE

Undergo sentinel lymph node mapping

Also known as: lymphatic mapping

Ancillary-Correlative (biospecimen collection, node mapping)

Sentinel Lymph Node Biopsy PROCEDURE

Undergo sentinel lymph node biopsy

Also known as: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

Ancillary-Correlative (biospecimen collection, node mapping)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with low risk endometrial cancer who are scheduled to have a hysterectomy

You may qualify if:

• Histologically confirmed low grade (grade 1-2) endometrioid type adenocarcinoma
• Candidate for surgery
• No evidence of deep invasion or peritoneal disease in patients that have undergone preoperative imaging
• Patients may have had prior hormonal treatment for the treatment of early endometrial neoplasia. Patients may not have had prior radiation or chemotherapy for treatment of endometrial cancer
• Patients must have a negative pregnancy if of childbearing potential

You may not qualify if:

• Histologically confirmed high grade endometrioid or non-endometrioid type endometrial cancer (including serous, clear cell, carcinosarcoma or any mixed tumor containing these cell types)
• Medical co-morbidities making surgery unsafe, as determined by the primary treating physician
• Evidence of deep myometrial invasion, cervical involvement or peritoneal disease on preoperative imaging
• Prior treatment with radiation or chemotherapy for endometrial cancer
• Any contraindication to lymph node mapping

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Interventions

Ovariectomy; Hysterectomy; Sentinel Lymph Node Biopsy

Intervention Hierarchy (Ancestors)

Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Lymph Node Excision; Investigative Techniques

Study Officials

• Shannon N Westin

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: November 8, 2012
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)