Ovarian Screening Study - Full Text View

Sponsors and Collaborators:	James Graham Brown Cancer Center University of Louisville
Information provided by:	James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:	NCT00267072

Purpose

The objectives of this study are:

To identify women at increased risk for developing ovarian cancer
To detect ovarian cancers at an early stage
To investigate the role of tumor membrane fragments as tumor markers for early ovarian carcinoma

Condition
Ovarian Cancer

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The University of Louisville Ovarian Screening Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by James Graham Brown Cancer Center:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	5000
Study Start Date:	June 2001
Estimated Study Completion Date:	May 2009

Detailed Description:

In the year 2001 approximately 23,400 women in the USA are expected to be diagnosed with ovarian carcinoma and 13,900 will die of the disease. This means that within the USA more women die annually from ovarian cancer than all other gynecologic malignancies combined. Within the Commonwealth of Kentucky approximately 250 women per year develop ovarian carcinoma.

Survival for patients with ovarian cancer is directly related to the stage of disease at diagnosis.

Unfortunately, the majority of women present with advanced disease (Stage III and IV) and most of these patients will die of the disease.

The aim of screening for ovarian cancer is to reduce the morbidity and mortality by detecting the disease at an early stage since ovarian cancer detected when disease is confined to the ovary (Stage I) is associated with a dramatically improved 5-year survival. Disease confined to the ovary may be cured in over 90% of patients, in some cases without the need for chemotherapy.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

community sample

Criteria

Inclusion Criteria:

Asymptomatic women over the age of 45 with one or both ovaries.
Women over the age of 25 with one or both ovaries and any of the following:
- A personal history of breast, colon or endometrial cancer or breast cancer gene (BRCA) 1 or 2 positive
- First-degree relative (mother, sister, daughter) with ovarian or breast cancer
- Two family members with either breast and/or ovarian cancer
- Mother, sister, daughter, grandparent with a positive BRCA1 or BRCA2 genetic test result.
- Past use of fertility drugs such as Clomid or Pergonal for more than a year.

Exclusion Criteria:

Women who are symptomatic of ovarian cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267072

Contacts

Contact: Jane Helm

502-561-7259

Locations

United States, Kentucky
James Graham Brown Cancer Center	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jane Helm 502-561-7259
Principal Investigator: Cyril W. Helm, MD

Sponsors and Collaborators

James Graham Brown Cancer Center

University of Louisville

Investigators

Principal Investigator:

Cyril W. Helm, MD

University of Louisville, James Graham Brown Cancer Center

More Information

Publications:

1 Greenlee, R. T., M. B. Hill-Harmon, et al. (2001). "Cancer Statistics 2001." CA Cancer Journal for Clinicians 51: 15-36. 2 FIGO (1998). "Annual Report on the Results of Treatment in Gynaecological Cancer." Journal of Epidemiology and Biostatistics 3: 1-168. 3 National Institutes of Health Consensus Development Conference Statement (1994). "Ovarian Cancer: Screening, Treatment and Follow-up." Gynecologic Oncology 55: S4-S14. 4 Sassone, M. A., I. E. Timor-Tritsch, et al. (1991). "Transvaginal Sonographic Characterization of Ovarian Disease: Evaluation of a New Scoring System to Predict Ovarian Malignancy." Obstet Gyncecol 78: 70-76. 5 Campbell, S., V. Bhan, et al. (1989). "Transabdominal ultrasound screening for early ovarian cancer." BMJ 299: 1363-1366. 6 Van Nagell, J. R., R. V. Higgins, et al. (1990). "Transvaginal Sonography as a Screening Method for Ovarian Cancer." Cancer 65: 573-577 7 Jacobs, I. and R. C. Bast (1989). "The CA125 tumor associated antigen. A Review of the literature." Hum Repro 4: 1-12. 8 Einhorn, N., K. Sjovall, et al. (1992). "Prospective Evaluation of Serum CA 125 Levels for Early Detection of Ovarian Cancer." Obstet Gynecol 80: 14-18. 9 Menon, U. and I. J. Jacobs (2000). Tumor Markers and Screening. Practical Gynecologic Oncology. J. S. Berek and N. F. Hacker. Philadelphia, Lippincott Williams and Willkins: 39-58. 10 Taylor DD and Black PH: Inhibition of macrophage Ia antigen expression by shed plasma membrane vesicles from metastatic murine melanoma lines. J Nat Cancer Inst 74:859-867, 1985. 11 Taylor DD and Black PH: Neoplastic and developmental importance of plasma membrane vesicles. Amer Zool 26:411-415, 1987. 12 Taylor DD, Chou IN, and Black PH: Isolation of plasma membrane fragments from cultured murine melanoma cells. Biochem Biophys Res Comm 113:470-476, 1983. 13 Taylor DD, Homesley HD, and Doellgast GJ: Identification of antigenic components recognized by "membrane bound" antibodies from ovarian cancer patients. Am J Reprod Immunol 6:179-184, 1984. 14 Ries, L. A. G., C. L. Kosary, et al., Eds. (1999). SEER Cancer Statistics Review 1973-1996. Bethesda, MD, NCI. 15 Schildkraut, J. M. and W. D. Thompson (1988). "Familial Ovarian Cancer: A population-based case-control study." Am J of Epidem 128: 456-466. 16 Newman, B., R. C. Millikan, et al. (1997). "Genetic Epidemiology of Breast and Ovarian Cancers." Epidemiologic Reviews 19: 69-79.

Responsible Party:	James Graham Brown Cancer Center ( C. William Helm, MD )
Study ID Numbers:	328.01
Study First Received:	December 19, 2005
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00267072 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:

Ovarian Cancer

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009