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Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma

NCT01322750 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3125

Last updated 2011-03-25

No results posted yet for this study

Summary

With an estimated \> 2 million women with undetected breast cancer in the United States, the need for improved early detection is imperative. Early diagnosis for these women is key to minimizing quality life-years lost to disease and optimizing success of treatment. Evidence now exists supporting the finding that systemic spread is an early event in the natural history of breast cancer, manifested as a release of single cancer cells from the incident, clinically undetectable tumor, which circulate through the bloodstream and deposit within remote tissues. Reliable and accurate detection of these circulating tumor cells (CTCs) is now possible with a simple peripheral venous blood draw. This study hypothesizes that women with CTCs and no other signs of malignancy have clinically undetectable disease.

This study will attempt to validate this technology as a breast cancer screening test and acquire data to determine the clinical validity and utility of this proposed screening methodology on a relatively young, ethnically diverse population who are eligible military health care beneficiaries. Furthermore, this study will attempt to bank identified CTCs in order to perform additional molecular analyses in the future. The specific aims are to develop a simple, reliable, cost-effective, and clinically relevant breast cancer screening test in order to identify subclinical disease early in its natural history in subjects at risk of progression to clinically apparent disease over the ensuing decade. The ultimate goal is to decrease the treatment-related morbidity and cause-specific mortality of breast cancer. An experienced team devoted to the care of patients with breast disease has been assembled to achieve this goal.

Conditions

  • Breast Abnormality

Sponsors & Collaborators

  • Bureau of Navy Medicine (BUMED)

    collaborator UNKNOWN

  • Walter Reed Army Medical Center

    lead FED

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-01-31
Completion
2023-01-31

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 NCT01322750 on ClinicalTrials.gov