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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01322750
Recruitment Status : Recruiting
First Posted : March 25, 2011
Last Update Posted : March 25, 2011
Bureau of Navy Medicine (BUMED)
Information provided by:
Walter Reed Army Medical Center

Brief 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.

Condition or disease
Breast Abnormality

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Study Type : Observational
Estimated Enrollment : 3125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma
Study Start Date : December 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

With CTCs
Those individuals whom are identified with CTCs
Without CTCs
Those individuals whom present and did not have CTCs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All adults (> 18 years of age) presenting for evaluation at breast center - who subsequently undergo a diagnostic or therapeutic procedure and who do not have a prior history of invasive carcinoma or clinically-apparent metastatic disease, will be eligible for enrollment.

Inclusion Criteria:

  • Adults 18 years of age or older
  • Mentally competent and willing to provide written informed consent prior to entering the study
  • Military healthcare beneficiary
  • Undergoing a diagnostic or therapeutic procedure (biopsy, lumpectomy, mastectomy) in the breast clinic or operating room.
  • Present to the CBCP and willing to be followed at the CBCP during the course of treatment and follow-up

Exclusion Criteria:

  • Prior history of invasive carcinoma
  • Presence of clinically-apparent metastatic disease
  • Participants with known human immunodeficiency virus (HIV), any history of hepatitis, prion-mediated disease, drug resistant tuberculosis or other infectious disease presenting a significant risk to personnel handling tissue or blood-derived products shall be excluded from participation
  • Participants with pre-existing coagulopathies or all other conditions, for whom invasive biopsy or surgery is medically contraindicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01322750

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Contact: Thomas A Summers, MD 202 782 7743

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United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Thomas P Baker, MD    202-782-7743   
Sponsors and Collaborators
Walter Reed Army Medical Center
Bureau of Navy Medicine (BUMED)
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Responsible Party: Thomas A Summers, Jr, Walter Reed Army Medical Center Identifier: NCT01322750    
Other Study ID Numbers: 354344
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: March 25, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes