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

This study is currently recruiting participants.

Verified by Memorial Sloan-Kettering Cancer Center, December 2008

First Received: December 21, 2007 Last Updated: December 9, 2008 History of Changes

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Johns Hopkins University M.D. Anderson Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00587093

Purpose

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.

Condition	Intervention
Ovarian Cancer	Other: CT scan

MedlinePlus related topics: CT Scans Cancer Nuclear Scans Ovarian Cancer Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To assess the efficacy of preoperative CT scan of the abdomen and pelvis in predicting optimal primary cytoreduction in advanced ovarian cancer. [ Time Frame: 7 - 35 days postop stage 3 or 4 disease CTscan have ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the ability of preoperative serum CA-125 to predict optimal primary cytoreduction of advanced ovarian cancer. [ Time Frame: 7-35 days postop CT scan ] [ Designated as safety issue: No ]

Estimated Enrollment:	510
Study Start Date:	July 2001
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 CT scan and CA-125	Other: CT scan CT scan done at 7 - 35 days postop for Stage III or IV patients

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587093

Contacts

Contact: Dennis Chi, M.D.

chid@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Dennis Chi, M.D. chid@mskcc.org
Principal Investigator: Dennis Chi, M.D.

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Johns Hopkins University

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Dennis Chi, M.D.

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Dennis Chi. M.D. )
Study ID Numbers:	01-048
Study First Received:	December 21, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00587093 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Newly diagnosed
No stage

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009