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Cervical Cancer | Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

Cervical Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cervical Cancer

Endometrial Cancer

Fallopian Tube Cancer

Hereditary Breast/Ovarian Cancer (brca1, brca2)

Ovarian Cancer

Sarcoma

Uterine Leiomyomata

Vaginal Cancer

Vulvar Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:laboratory biomarker analysisSubject'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 administrationQuestionnaires 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 factorsSubjects will be assessed for high risk factors.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

High Risk for Ovarian CancerWomen 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.

Study Status

Recruiting

Start Date: March 2000

Completed Date:

Phase:

Type: Observational

Design:

Primary Outcome: Identification and development of highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies

Secondary Outcome: Identification of new prevention approaches and therapies

Study sponsors, principal investigator, and references

Principal Investigator: Lee P. Shulman, MD

Lead Sponsor: Northwestern University

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT00005095

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