Prediction of Recurrence Among Low Risk Endometrial Cancer Patients

February 26, 2024 updated by: M.D. Anderson Cancer Center

Prediction of Recurrence Among Low Risk Endometrial Cancer Population

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.

Study Overview

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Shannon N. Westin
        • Contact:
          • Shannon N. Westin
          • Phone Number: 713-794-4314

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Correlative studies
Undergo collection of blood and tissue samples
Undergo standard of care bilateral salpingo-oophorectomy
Other Names:
  • bilateral salpingo-oophorectomy
Undergo standard of care hysterectomy
Other Names:
  • Hysterectomy NOS
Undergo sentinel lymph node mapping
Other Names:
  • lymphatic mapping
Undergo sentinel lymph node biopsy
Other Names:
  • Sentinel Node Biopsy
  • Sentinel node biopsy alone
  • SLNB
  • SNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year recurrence
Time Frame: At 2 years
Will validate a model's ability to predict 2-year recurrence in low-risk endometrial cancer patients.
At 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive ability of lymph node mapping in pelvic lymph node involvement
Time Frame: Up to 2 years
Will calculate the sensitivity (true positive fraction [TPF]), specificity (1-false positive fraction [FPF]), positive predictive value (PPV), and negative predictive value (NPV) of lymph node mapping in predicting pelvic lymph node involvement, along with 2-sided 95% confidence intervals.
Up to 2 years
Feasibility of lymph node mapping
Time Frame: Up to 2 years
Feasibility of lymph node mapping in this patient population will be determined after examining the TPF, FPF, PPV, and NPV.
Up to 2 years
Morbidity and mortality prevalence associated with lymph node dissection
Time Frame: Up to 2 years
Morbidity and mortality prevalence associated with lymph node dissection and mapping will be calculated with 95% confidence intervals.
Up to 2 years
Patterns of recurrence
Time Frame: Up to 2 years
Will determine which demographic and clinical traits are most associated with recurrence rate using proportional hazards models and with 2-year recurrence using logistic regression models. Will conduct univariate analyses using log-rank tests and Fisher's exact tests, in the case of categorical traits, and proportional hazards and logistic regression models, in the case of continuous traits. Will examine all traits for violations of the proportional hazards assumption (recurrence rate models), and will examine all continuous traits for functional form (recurrence and recurrence rate models). Will use the same methods to determine whether CA125 and HE4 is associated with recurrence and recurrence rate.
Up to 2 years
Predictive ability of molecular panel in lymph node involvement
Time Frame: Up to 2 years
Will use Cartesian and Regression Tree Analysis and logistic regression to determine if the molecular panel can predict lymph node involvement. Will assess the use of the model by calculating sensitivity, specificity, PPV, and NPV. Additionally, will examine how often the results of the molecular panel model concur with the Mayo low risk criteria for prediction of lymph node involvement. All agreement statistics will be presented with their 95% confidence intervals.
Up to 2 years
Predictive ability of marker panel in recurrence
Time Frame: Up to 2 years
Will examine how well the predictive ability of the marker panel agrees with the predictive ability of the high intermediate risk criteria from Gynecologic Oncology Group, trial 99 using this patient population. 95% confidence intervals will be calculated for all concordance statistics.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shannon N Westin, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2012

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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