Prediction of Recurrence Among Low Risk Endometrial Cancer Patients
NCT ID: NCT04604613
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
518 participants
OBSERVATIONAL
2012-11-08
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study
NCT06689956
Role of Biomarkers in Endometrial Cancer Recurrence in Samples From Patients With Stage II, Stage III, or Stage IV Endometrial Cancer
NCT01150682
Molecular and ctDNA Characterization of High-Risk Endometrial Cancer
NCT07062016
Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer
NCT01119573
SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in P53-Mutated Endometrial Cancer: a Non-Inferiority Randomized Trial
NCT06900582
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Bilateral Salpingectomy with Oophorectomy
Undergo standard of care bilateral salpingo-oophorectomy
Biospecimen Collection
Undergo collection of blood and tissue samples
Hysterectomy
Undergo standard of care hysterectomy
Laboratory Biomarker Analysis
Correlative studies
Lymph Node Mapping
Undergo sentinel lymph node mapping
Sentinel Lymph Node Biopsy
Undergo sentinel lymph node biopsy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bilateral Salpingectomy with Oophorectomy
Undergo standard of care bilateral salpingo-oophorectomy
Biospecimen Collection
Undergo collection of blood and tissue samples
Hysterectomy
Undergo standard of care hysterectomy
Laboratory Biomarker Analysis
Correlative studies
Lymph Node Mapping
Undergo sentinel lymph node mapping
Sentinel Lymph Node Biopsy
Undergo sentinel lymph node biopsy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shannon N Westin
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
M D Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2020-07548
Identifier Type: REGISTRY
Identifier Source: secondary_id
PA12-0550
Identifier Type: OTHER
Identifier Source: secondary_id
PA12-0550
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.