A Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Ovarian Cancer

Treatments: Other: CA 125 and CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT00587093

01-048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 669 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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669 participants in 1 patient group

1

Other group

Description:

CT scan and CA-125

Treatment:

Other: CA 125 and CT scan