Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Recurrence

Endometrial Neoplasms

Carcinoma

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Ovarian Neoplasms

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Ovarian Cancer

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.

Undergo standard of care bilateral salpingo-oophorectomy

Bilateral Salpingectomy with Oophorectomy

Undergo collection of blood and tissue samples

Biospecimen Collection

Hysterectomy

Laboratory Biomarker Analysis

Lymph Node Mapping

Sentinel Lymph Node Biopsy

Shannon N Westin

Shannon N. Westin

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.

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.

Prediction of Recurrence Among Low Risk Endometrial Cancer Patients

Prediction of Recurrence Among Low Risk Endometrial Cancer Population

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

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.

Feasibility of lymph node mapping in this patient population will be determined after examining the TPF, FPF, PPV, and NPV.

Morbidity and mortality prevalence associated with lymph node dissection and mapping will be calculated with 95% confidence intervals.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prediction of Recurrence Among Low Risk Endometrial Cancer Patients	NCT04604613	FIGO Grade 1 En... FIGO Grade 2 En...	Bilateral Salpi... Biospecimen Col... Hysterectomy Laboratory Biom... Lymph Node Mapp... Sentinel Lymph ...	-	M.D. Anderson Cancer Center
Prediction of Recurrence Among Low Risk Endometrial Cancer Patients	NCT04604613	FIGO Grade 1 En... FIGO Grade 2 En...	Bilateral Salpi... Biospecimen Col... Hysterectomy Laboratory Biom... Lymph Node Mapp... Sentinel Lymph ...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for bilateral salpingectomy with oophorectomy