Prediction of Recurrence Among Low Risk Endometrial Cancer Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 518
- Locations
- 1
- Primary Endpoint
- 2-year recurrence
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Bilateral Salpingectomy with Oophorectomy (Procedure)
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.
Intervention: Biospecimen Collection (Procedure)
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.
Intervention: Hysterectomy (Procedure)
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.
Intervention: Laboratory Biomarker Analysis (Other)
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.
Intervention: Lymph Node Mapping (Procedure)
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.
Intervention: Sentinel Lymph Node Biopsy (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Morbidity and mortality prevalence associated with lymph node dissection(Up to 2 years)
- Predictive ability of marker panel in recurrence(Up to 2 years)
- Predictive ability of lymph node mapping in pelvic lymph node involvement(Up to 2 years)
- Patterns of recurrence(Up to 2 years)
- Feasibility of lymph node mapping(Up to 2 years)
- Predictive ability of molecular panel in lymph node involvement(Up to 2 years)