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Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer


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.


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.)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To assess the efficacy of preoperative CT scan of the abdomen and pelvis in predicting optimal primary cytoreduction in advanced ovarian cancer.

Outcome Time Frame:

7 - 35 days postop stage 3 or 4 disease CTscan have

Safety Issue:

No

Principal Investigator

Dennis Chi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

01-048

NCT ID:

NCT00587093

Start Date:

July 2001

Completion Date:

July 2014

Related Keywords:

  • Ovarian Cancer
  • Newly diagnosed
  • CA 125
  • CT scan
  • 01-048
  • Ovarian Neoplasms

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
The Johns Hopkins Hospital Baltimore, Maryland  21205