NCT00587093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
669

participants targeted

Target at P75+ for not_applicable ovarian-cancer

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable ovarian-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

16.6 years

First QC Date

December 21, 2007

Last Update Submit

February 20, 2018

Conditions

Ovarian Cancer

Keywords

Newly diagnosedCA 125CT scan01-048

Outcome Measures

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.

    7 - 35 days postop stage 3 or 4 disease CTscan have

Secondary Outcomes (4)

  • To evaluate the ability of preoperative serum CA-125 to predict optimal primary cytoreduction of advanced ovarian cancer.

    Within 14 days prior to surgery

  • To develop preoperative CT scan of the abdomen and pelvis and/or tumor marker criteria for ovarian cancer non-resectability (sub-optimal tumor cytoreduction).

    3 years

  • To determine the ability of preoperative CT scan of the abdomen and pelvis to provide useful information that will impact on surgical planning.

    3 years

  • 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.

    3 years

Study Arms (1)

1

OTHER

CT scan and CA-125

Other: CA 125 and CT scan

Interventions

CA 125 and CT scanOTHER

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

CA-125 Antigen

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

MucinsMucoproteinsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsAntigens, Tumor-Associated, CarbohydrateAntigens, NeoplasmAntigensBiological FactorsEpitopesBiomarkers, TumorBiomarkers

Study Officials

  • Dennis Chi, M.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

July 1, 2001

Primary Completion

February 16, 2018

Study Completion

February 16, 2018

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

US(5)