A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001938
Recruitment Status : Completed
First Posted : January 19, 2000
Last Update Posted : October 19, 2017
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Every cell in the human body contains hundreds of thousands of genes and the proteins made by the genes. Sometimes changes take place in the genes or proteins that may make the cells more likely to develop into cancer. An experimental protein profile test that finds these changes may be able to provide information about whose cancer will stay in remission and whose will return.

Volunteer patients whose epithelial ovarian cancer is in remission are eligible for this study. Specimens will be collected from blood, saliva, and urine for the first protein profile test. Sample sets for more protein profile tests will be collected at follow-up visits 1 month and 3 months later and every 3 months afterward. If and when the cancer returns, an additional sample set will be obtained and a biopsy of the relapsed tumor will be taken both for a protein profile test and for review of the function and structure of the disease (pathology review). The protein profiles from these samples will be compared to those samples already collected to detect protein pattern changes. The amount of lysophosphatidic acid (LPA) in the blood, a sign of ovarian cancer, will also be measured to see if LPA is useful in detecting the return of ovarian cancer.

If patients get fluid in the stomach or chest, it will be tested for cancer cells and proteins made by the tumor. If a physical exam or CT scan indicates a possible return of the cancer, a biopsy will be performed and a sample saved for a protein profile.

Condition or disease
Ovarian Neoplasm

Detailed Description:
Over 80 percent of advanced stage epithelial cancer patients relapse after attaining first clinical remission with standard platinum/paclitaxel-based chemotherapy. Surrogate biomarkers are needed for the evaluation of efficacy of treatment and for use as predictors of disease in screening and for relapse diagnosis. CA-125, the existing ovarian cancer marker, will become elevated with relapse in some but not all of the 80 percent of patients for whom it was increased at initial diagnosis. Elevation in CA-125 may precede clinical evidence of relapse by as much as 6 - 10 months or lag behind clinical relapse by the same time intervals, making it a less than satisfactory clinical tool. Emerging proteomic technologies allow for scanning of cellular proteins in a simple, short, reproducible, and quantitative chemical assay. We hypothesize that changes in a patient s protein pattern will be detectable and will be reliably associated with relapse. This protocol is a pilot study for our ability to ascertain and evaluate samples from ovarian cancer patients followed in first clinical remission, and investigate whether analysis of sequential protein fingerprints will yield a reproducible pattern of change that may be associated with relapse.

Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile Associated With Relapse
Study Start Date : November 17, 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Biomarker analysis [ Time Frame: At 1 mo; every 3 mos; at progression or 24 mos of complete clinical remission; every 6 mos after 3 yrs on study; and annually after 5 yrs on study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

All patients in first clinical remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma or stage IIC clear cell histology epithelial ovarian cancer as defined by: normal CA-125, normal physical exam, normal post hysterectomy pelvic examination, no evidence of disease on CT scan or other noninvasive reassessment.

Entry within 9 weeks of completion of final cycle of chemotherapy (within 12 weeks of last administration of chemotherapy).

S/P completion of primary therapy with standard platinum/paclitaxel or carboplatin/paclitaxel-containing chemotherapy and in confirmed clinical complete response.

At least one block from the primary tumor must be received. (If available, a sample of frozen primary tumor should also be forwarded).

ECOG performance status of 0, 1, or 2.


Patients with nonepithelial ovarian cancer, or mixed epithelial/nonepithelial ovarian cancer.

Patients may not be receiving chemotherapy, hormonal therapy, alternative therapy, or radiation therapy. No therapy of any kind is allowed while the patient is on-study. Replacement hormonal therapy is not allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001938

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Elise C Kohn, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00001938     History of Changes
Obsolete Identifiers: NCT00020033
Other Study ID Numbers: 000018
First Posted: January 19, 2000    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: May 22, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders