Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers
Completed
Conditions studied: Fallopian Tube Cancer, Peritoneal Neoplasms, Epithelial Ovarian Cancer
In brief
This study will develop a blood test that can be used to predict a relapse of ovarian, peritoneal, or fallopian tube cancer. The type of testing is called proteomics, or the study of proteins in living cells. The test will identify certain proteins that might represent a pattern, or "fingerprint," indicating increased risk of disease relapse. Women with Stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is in remission may be eligible for this study. Candidates are screened with a medical history and physical examination, blood tests, review of pathology report from surgery, and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the abdomen and pelvis (and chest if the cancer spread to the chest). Participants have a clinic visit every 3 months for a physical examination (including a pelvic examination), blood draw for routine and research tests, and review of how they have been feeling. Every 6 months they have CT scans of the abdomen, pelvis, and possibly the chest. When a patient has been in remission for 4 years, blood draws are done every 6 months and CT scans are done yearly. Patients whose cancer returns (based on a CA-125 blood test, CT scans, or physical examination) end their participation in the study. Patients with an abnormal CT scan or physical examination may be asked to undergo a tumor biopsy (surgical removal of a piece of tumor tissue) for research purposes. ...
Key facts
- Study ID
- NCT00086567
- Run by
- National Cancer Institute (NCI)
- People needed
- 119
- Starts
- 2005-12-12
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- 2.1<TAB>Patients with nonepithelial ovarian cancer, mixed epithelial/nonepithelial ovarian cancer (i.e., Mixed Malignant Mullerian Tumors), or tumors of low malignant potential. Patients with stage I or II epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- 2.2<TAB>Patients may not be receiving chemotherapy (therapeutic or consolidation), maintenance, alternative therapy, or radiation therapy. No anti-cancer therapy of any kind is allowed while the patient is on-study. Replacement hormonal therapy is allowed but must be clearly indicated on the case report forms submitted. Hormonal anti-cancer therapies such as tamoxifen and raloxifene will not be permitted while on study.
- 2.3<TAB>Patients with a life expectancy of less than 6 months for any reason.
- 2.4 <TAB>Patients with a history of other invasive malignancies within the past five years prior to enrollment except for curatively treated carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, concomitant stage I endometrial cancer, or basal or squamous cell skin cancers.
- 2.5 <TAB>Complementary and alternative agent use is discouraged on this study due to the possibility that the use of these agents may alter the serum protein pattern. The Institutional Principal Investigator will have discretion as to whether complementary or alternative agent usage will prevent eligibility on a case by case basis.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Evanston Northwestern University Hospital — Evanston, Illinois, United States
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
- Massachusetts General Hospital, Dana Farber — Boston, Massachusetts, United States
- New York University School of Medicine — New York, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- University of Washington/Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
- Pacific Ovarian Cancer Research Consortium at FHCRC — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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