Back to resultsA Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CA 125 and CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Ovarian Cancer focused on measuring Newly diagnosed, CA 125, CT scan, 01-048
Eligibility 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.)
Sites / Locations
- The Johns Hopkins Hospital
- Memoral Sloan Kettering Cancer Center
- Memorial Sloan Kettering Cancer Center @ Suffolk
- Memorial Sloan Kettering Cancer Center
- Md Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
CT scan and CA-125
Outcomes
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.
Secondary Outcome Measures
To evaluate the ability of preoperative serum CA-125 to predict optimal primary cytoreduction of advanced ovarian cancer.
To develop preoperative CT scan of the abdomen and pelvis and/or tumor marker criteria for ovarian cancer non-resectability (sub-optimal tumor cytoreduction).
To determine the ability of preoperative CT scan of the abdomen and pelvis to provide useful information that will impact on surgical planning.
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.
Full Information
NCT ID
NCT00587093
First Posted
December 21, 2007
Last Updated
February 20, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Johns Hopkins University, M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00587093
Brief Title
A Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer
Official Title
Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2001 (Actual)
Primary Completion Date
February 16, 2018 (Actual)
Study Completion Date
February 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Johns Hopkins University, M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Newly diagnosed, CA 125, CT scan, 01-048
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
669 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
CT scan and CA-125
Intervention Type
Other
Intervention Name(s)
CA 125 and CT scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Chi, M.D.
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Memoral Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
A Multicenter Trial On The Utility and Impact Of Computed Tomography and Serum CA-125 In the Management of Newly Diagnosed Ovarian Cancer
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