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 ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Johns Hopkins University
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00587093
First received: December 21, 2007
Last updated: April 10, 2014
Last verified: April 2014

December 21, 2007
April 10, 2014
July 2001
July 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00587093 on ClinicalTrials.gov Archive Site
  • To evaluate the ability of preoperative serum CA-125 to predict optimal primary cytoreduction of advanced ovarian cancer. [ Time Frame: Within 14 days prior to surgery ] [ Designated as safety issue: No ]
  • To develop preoperative CT scan of the abdomen and pelvis and/or tumor marker criteria for ovarian cancer non-resectability (sub-optimal tumor cytoreduction). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine the ability of preoperative CT scan of the abdomen and pelvis to provide useful information that will impact on surgical planning. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
A Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer
Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Ovarian Cancer
Other: 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.
1
CT scan and CA-125
Intervention: Other: CA 125 and CT scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
July 2015
July 2015   (final data collection date for primary outcome measure)

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.)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587093
01-048
No
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Johns Hopkins University
  • M.D. Anderson Cancer Center
Principal Investigator: Dennis Chi, M.D. Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP