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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 April 2013 |
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Main ID: |
NCT00587093 |
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Date of registration:
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21/12/2007 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Multicenter Trial on Utility and Impact of Computed Tomography and Serum CA-125 in Management of Newly Diagnosed Ovarian Cancer |
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Date of first enrolment:
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July 2001 |
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Target sample size:
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600 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00587093 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Dennis Chi, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Memorial Sloan-Kettering Cancer Center |
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Key inclusion & exclusion 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.)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Intervention(s)
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Other: CA 125 and CT scan
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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