Full Text View
Tabular View
No Study Results Posted
Related Studies
Screening Methods for Finding Ovarian Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: April 6, 2000   Last Updated: November 26, 2009   History of Changes
Sponsor: Robert H. Lurie Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005095
  Purpose

RATIONALE: Screening may help doctors find ovarian cancer sooner, when it may be easier to treat. It may also help doctors plan better treatment for ovarian cancer.

PURPOSE: This clinical trial is studying screening methods for identifying women who are at increased risk for developing ovarian cancer.


Condition Intervention
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Hereditary Breast/Ovarian Cancer (brca1, brca2)
Ovarian Cancer
Sarcoma
Uterine Leiomyomata
Vaginal Cancer
Vulvar Cancer
Other: laboratory biomarker analysis
Other: screening questionnaire administration
Procedure: evaluation of cancer risk factors
Procedure: study of high risk factors

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Northwestern Ovarian Cancer Early Detection & Prevention Program

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Identification and development of highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies [ Designated as safety issue: No ]
  • Identification of new prevention approaches and therapies [ Designated as safety issue: No ]
  • Identification of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: March 2000
Detailed Description:

OBJECTIVES:

  • To identify and develop highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies.
  • To identify new prevention approaches and therapies.
  • To identify measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer.

OUTLINE: Patients complete an extensive personal and family medical history questionnaire and meet with a genetic counselor to review the questionnaire and for a risk assessment at baseline. Patients also undergo transvaginal ultrasound, clinical breast, pelvic, and rectal exam, and CA-125 testing at baseline and then every 6 months thereafter, or as determined by the physician. Patients also complete additional questionnaires periodically.

Patients undergo blood sample collection periodically for research studies, including molecular, biochemical, functional, and genetic marker studies.

The referring physician will be notified of any abnormal test results. The results from the biomarker research studies will not be reported to the patient or the physician. In the future, if any of the experimental tumor markers are found to be effective in detecting early stage ovarian cancer, and the patient's result is abnormal, the patient and physician will be notified.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Meets one of the following criteria:

    • Asymptomatic AND considered to be at increased risk for developing ovarian cancer, as defined by one of the following:

      • Personal history of breast or colon cancer
      • Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer
      • Has a personal or family history of hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)
      • Has at least two family members with breast, ovarian, primary peritoneal, fallopian tube, uterine, and/or pancreatic cancer
    • Undergoing surgery for a gynecologic condition, including any of the following:

      • Diagnosis of a reproductive cancer
      • Benign gynecological condition (e.g., uterine leiomyomata, endometriosis, pelvic inflammatory disease, or follicular or corpus luteum ovarian cysts)
      • Highly suspicious adnexal mass
      • Risk-reducing prophylactic oophorectomy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005095

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Lee P. Shulman, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067757, NU-99G8, NU-99G7, NCI-G00-1753
Study First Received: April 6, 2000
Last Updated: November 26, 2009
ClinicalTrials.gov Identifier: NCT00005095     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ovarian epithelial cancer
hereditary breast/ovarian cancer (BRCA1, BRCA2)
fallopian tube cancer
ovarian germ cell tumor
ovarian sarcoma
ovarian stromal cancer
endometrial cancer
uterine sarcoma
vaginal cancer
cervical cancer
vulvar cancer
uterine leiomyomata

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Gonadal Disorders
Vaginal Diseases
Urogenital Neoplasms
Ovarian Diseases
Leiomyoma
Uterine Cervical Neoplasms
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Endometrial Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Vulvar Neoplasms
Connective Tissue Diseases
Uterine Neoplasms
Endocrine Gland Neoplasms
Vaginal Neoplasms
Myofibroma
Ovarian Neoplasms
Neoplasms by Histologic Type
Genital Neoplasms, Female
Endocrine System Diseases
Uterine Diseases
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Neoplasms
Sarcoma
Neoplasms, Connective Tissue
Vulvar Diseases

ClinicalTrials.gov processed this record on March 18, 2010