RecruitingNCT00005095

Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study


Sponsor

Northwestern University

Enrollment

6,000 participants

Start Date

Mar 1, 2000

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria15

  • 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

Interventions

OTHERCa-125

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.

OTHERscreening 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.

PROCEDURESurgery

Subjects will be assessed for high risk factors.


Locations(1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

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NCT00005095


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