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)

NCT00001938 | Completed

• 2 other identifiers: 00001800-C-0018
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasm

Keywords

Ovarian Cancer; Proteomics

Outcome Measures

Primary Outcomes (1)

• Biomarker analysis

  creation of protein profiles of epithelial ovarian cancer

  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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary clinical population of patients in first clinical remisssion from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma or stage II clear cell histology epithelial ovarian cancer. Entry 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 inconfirmed clinical complete response.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Patsner B, Orr JW Jr, Mann WJ Jr, Taylor PT, Partridge E, Allmen T. Does serum CA-125 level prior to second-look laparotomy for invasive ovarian adenocarcinoma predict size of residual disease? Gynecol Oncol. 1990 Sep;38(3):373-6. doi: 10.1016/0090-8258(90)90076-w.

  PMID: 2227551 BACKGROUND

• Woolas RP, Xu FJ, Jacobs IJ, Yu YH, Daly L, Berchuck A, Soper JT, Clarke-Pearson DL, Oram DH, Bast RC Jr. Elevation of multiple serum markers in patients with stage I ovarian cancer. J Natl Cancer Inst. 1993 Nov 3;85(21):1748-51. doi: 10.1093/jnci/85.21.1748.

  PMID: 8411259 BACKGROUND

• Rosenthal A, Jacobs I. Ovarian cancer screening. Semin Oncol. 1998 Jun;25(3):315-25.

  PMID: 9633843 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, urine, pleural/peritoneal fluid, tissue

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Elise C Kohn, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: April 24, 2000
• Primary Completion: December 31, 2012
• Study Completion: March 10, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

US (1)