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Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer

NCT01292733 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2016-01-20

No results posted yet for this study

Summary

The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.

Conditions

  • Ovarian Diseases
  • Ovarian Neoplasms

Interventions

OTHER

Laboratory Tumor Marker Analysis

Performed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers.

OTHER

Transvaginal Ultrasound

Performed annually, these pelvic ultrasounds will be used used to look for 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity.

OTHER

Health Status Questionnaire

Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • The Marsha Rivkin Center for Ovarian Cancer Research

    collaborator OTHER

  • Swedish Medical Center

    lead OTHER

Principal Investigators

  • Pamela Paley, MD · Swedish Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01292733 on ClinicalTrials.gov