Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604613
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2020-10-21
Brief Title:
Prediction of Recurrence Among Low Risk Endometrial Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prediction of Recurrence Among Low Risk Endometrial Cancer Population
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 PPVnegative predictive value NPVsensitivity Sensspecificity 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 surgeons 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
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 PPVnegative predictive value NPVsensitivity Sensspecificity 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 surgeons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-07548 | REGISTRY | None | None |
| PA12-0550 | OTHER | M D Anderson Cancer Center | None |