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CompletedNCT00587093Updated Feb 22, 2018

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

An interventional study of CA 125 and CT scan in Ovarian Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 years 5 months after the study started (first participant enrolled Jul 2001, registered Dec 2007).
Phase
Not applicable
Study type
Interventional
Enrollment
669
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Ovarian Cancer

Keywords

  • Newly diagnosed
  • CA 125
  • CT scan
  • 01-048
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 669 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
669 participants (actual)

Study arms

  • Other
    1

    CT scan and CA-125

    Other: CA 125 and CT scan

Interventions

  • OtherCA 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.

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

5 sites
  • The Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
  • Memoral Sloan Kettering Cancer Center
    Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center @ Suffolk
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Md Anderson Cancer Center
    Houston, Texas 77030, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00587093
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Johns Hopkins University, M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jan 7, 2008
Start date
Jul 2001
Primary completion
Feb 16, 2018
Completion
Feb 16, 2018
Last update
Feb 22, 2018

Study contacts

Dennis Chi, M.D.
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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