- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04604613
Prediction of Recurrence Among Low Risk Endometrial Cancer Patients
Prediction of Recurrence Among Low Risk Endometrial Cancer Population
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Shannon N Westin
- Phone Number: 713-794-4314
- Email: swestin@mdanderson.org
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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:
Undergo standard of care hysterectomy
Other Names:
Undergo sentinel lymph node mapping
Other Names:
Undergo sentinel lymph node biopsy
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Shannon N Westin, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Ovarian Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Recurrence
- Adenocarcinoma
- Endometrial Neoplasms
- Carcinoma, Endometrioid
Other Study ID Numbers
- PA12-0550 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-07548 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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