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Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lee Shulman, Northwestern University
ClinicalTrials.gov Identifier:
NCT00005095
First received: April 6, 2000
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

RATIONALE: To improve strategies for detection and prevention of early-stage disease.

PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.


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: study of high risk factors

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study

Resource links provided by NLM:


Further study details as provided by Northwestern University:

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 [ Time Frame: Outcomes will be assessed at the completion of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification of new prevention approaches and therapies [ Time Frame: Outcomes will be assessed at the completion of the study. ] [ 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 [ Time Frame: Outcomes will be assessed at the completion of the study. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Subjects blood and other specimens are collected their follow-up clinic appointments.


Estimated Enrollment: 6000
Study Start Date: March 2000
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
High Risk for Ovarian Cancer
Women who are at increased risk of ovarian cancer based on family or personal medical history who are participating in the Northwestern Ovarian Cancer Early Detection and Prevention Program clinic.
Other: laboratory biomarker analysis
Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.
Other: screening questionnaire administration
Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.
Procedure: study of high risk factors
Subjects will be assessed for high risk factors.

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: Subjects undergo periodic specimen and data collection for research studies, including molecular, biochemical, functional, and genetic marker studies. Participants may have samples of blood, tissue, or body fluids (such as ascites, pleural fluid or urine), or any combination of the aforementioned samples obtained to develop tumor markers to detect early stage or recurrent ovarian cancer.

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.

Subjects may be asked to complete a combination of questionnaires designed to evaluate psychological functioning among women enrolled in a comprehensive ovarian cancer early detection program who are at increased risk for developing disease as compared to women currently diagnosed with ovarian cancer.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women at high risk of ovarian cancer due to family or personal medical history, or a gynecologic abnormality.

Criteria

DISEASE CHARACTERISTICS:

  • Meets one of the following criteria:

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

      • Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer
      • Has at least two first or second degree relatives diagnosed before age 50 with either ovarian, primary peritoneal, fallopian tube, and/or pancreatic cancer who have tested positive for hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)or have increased risk as deemed by a certified genetic counselor
      • A personal or family history of a hereditary cancer syndrome that includes an increased risk of gynecologic cancer
      • Increased risk as deemed by a certified genetic counselor
    • 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

  • Between the ages of 18 and 80
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Northwestern University
Investigators
Study Chair: Lee P. Shulman, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Lee Shulman, Chief, Division of Clinical Genetics, Northwestern University
ClinicalTrials.gov Identifier: NCT00005095     History of Changes
Other Study ID Numbers: NU 99G8, P30CA060553, NU-99G8, NCI-G00-1753
Study First Received: April 6, 2000
Last Updated: November 24, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014