Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 2, 2014
Last verified: April 2014

April 6, 2000
April 2, 2014
March 2000
December 2020   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00005095 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data 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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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

  • 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
    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.
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.
Interventions:
  • Other: laboratory biomarker analysis
  • Other: screening questionnaire administration
  • Procedure: study of high risk factors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6000
Not Provided
December 2020   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
United States
 
NCT00005095
NU 99G8, P30CA060553, NU-99G8, NCI-G00-1753
Yes
Lee Shulman, Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Lee P. Shulman, MD Robert H. Lurie Cancer Center
Northwestern University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP