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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

669 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2018-02-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

CT scan and CA-125

Group Type OTHER

CA 125 and CT scan

Intervention Type OTHER

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.

Interventions

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CA 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.

Intervention Type OTHER

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No