Ovarian Cancer
Conditions
Keywords
Newly diagnosed, CA 125, CT scan, 01-048
Brief summary
The purpose of the research is to determine if blood tests and a CT scan done before surgery can predict how successful the surgery will be. In patients who have cancer of the ovary that has spread, it is hoped that the CT scan will be able to identify the various places where the cancer has spread so that additional surgeons can be available to help with the surgical procedure. If you have confirmed stage 3 or 4 ovarian, fallopian tube, or primary peritoneal cancer, you may undergo a CT scan of the abdomen and pelvis after the surgery to compare how much cancer the surgeon thought was left after surgery to what is seen on CT scan. A CT scan of the chest will be done if your physician thinks it is necessary.
Detailed description
This study is designed to assess the utility and impact of computed tomography (CT)scanning of the abdomen and pelvis and preoperative serum CA-125 levels in the management of patients undergoing surgery for presumed ovarian cancer.
Interventions
OTHERCA 125 and CT scan
Within 14 days prior to surgery serum for CA125 will be obtained. The patient will also undergo a CT scan of the abdomen and pelvis with oral and intravenous contrast within 35 days prior to the procedure.
Sponsors
Johns Hopkins University
M.D. Anderson Cancer Center
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients \> 18 years of age undergoing surgery for presumed ovarian, fallopian tube, or primary peritoneal cancer. * Patients must be medically and physically able to undergo general anesthesia and possible tumor debulking. * Patients must read and sign informed consent form after the nature of the study has been fully explained.
Exclusion criteria
* Presence of clinically significant disease, allergy, or other disorder precluding the ability to safely perform CT scan of the abdomen and pelvis with oral and intravenous contrast. * Vulnerable patients (minors, mentally retarded patients, prisoners, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of preoperative CT scan of the abdomen and pelvis in predicting optimal primary cytoreduction in advanced ovarian cancer. | 7 - 35 days postop stage 3 or 4 disease CTscan have |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the ability of preoperative serum CA-125 to predict optimal primary cytoreduction of advanced ovarian cancer. | Within 14 days prior to surgery |
| To develop preoperative CT scan of the abdomen and pelvis and/or tumor marker criteria for ovarian cancer non-resectability (sub-optimal tumor cytoreduction). | 3 years |
| To determine the ability of preoperative CT scan of the abdomen and pelvis to provide useful information that will impact on surgical planning. | 3 years |
| To compare the intraoperative assessment of residual disease to that found on postoperative CT scan of the abdomen and pelvis, if scans are available for review. | 3 years |
Countries
United States
Outcome results
None listed