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Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

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ClinicalTrials.gov Identifier: NCT00005095
Recruitment Status : Recruiting
First Posted : January 27, 2003
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lee Shulman, Northwestern University

Tracking Information
First Submitted Date April 6, 2000
First Posted Date January 27, 2003
Last Update Posted Date September 30, 2016
Study Start Date March 2000
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2011)
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. ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: February 25, 2011)
  • Identification of new prevention approaches and therapies [ Time Frame: Outcomes will be assessed at the completion of the study. ]
  • 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. ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.

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.

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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Subjects blood and other specimens are collected their follow-up clinic appointments.
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.
Condition
  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • Ovarian Cancer
  • Sarcoma
  • Uterine Leiomyomata
  • Vaginal Cancer
  • Vulvar Cancer
Intervention
  • 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.
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 8, 2006)
6000
Original Enrollment Not Provided
Study Completion Date Not Provided
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005095
Other Study ID Numbers NU 99G8
P30CA060553 ( U.S. NIH Grant/Contract )
NU-99G8
NCI-G00-1753
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lee Shulman, Northwestern University
Study Sponsor Northwestern University
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Lee P. Shulman, MD Robert H. Lurie Cancer Center
PRS Account Northwestern University
Verification Date September 2016