Are you healthy and looking to help advance medical science?

You may be eligible to participate in a cervical cancer clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a cervical cancer clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Cervical Cancer Clinical Trial in Chicago IL

NCT00005095 | Observational

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a cervical cancer clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a cervical cancer clinical study, and could be compensated for your time.

Recruiting

Female

18 - 80

Years old

This study is looking to recruit 6000 Participants

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.

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Details for the study

Population

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

Brief Title

Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

Official Title

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

Brief Summary

RATIONALE: To improve strategies for detection and prevention of early-stage disease. <br /> <br /> PURPOSE: This research study is collecting specimens and data to develop better methods for <br /> early detection and prevention of ovarian cancer among the high risk population and those who <br /> have the disease.

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.

Treatments and/or Procedures

Surgery

Subjects will be assessed for high risk factors.

Ca 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.

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other

To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies

1 year

Secondary

new prevention approaches and therapies for risk assessment

To identify new prevention approaches and therapies by researching and reviewing the risk of developing disease.

1 year

Secondary

The develop of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer

To identify the measurements to improve the quality of life for women at increased risk for developing the disease

1 year

Study 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