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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by Walter Reed Army Medical Center
Sponsor:
Collaborator:
Bureau of Navy Medicine (BUMED)
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT01322750
First received: March 24, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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
Breast Abnormality

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Estimated Enrollment: 3125
Study Start Date: December 2010
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
With CTCs
Those individuals whom are identified with CTCs
Without CTCs
Those individuals whom present and did not have CTCs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322750

Contacts
Contact: Thomas A Summers, MD 202 782 7743 thomas.summersjr@us.army.mil

Locations
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    Thomas.P.Baker@us.army.mil   
Sponsors and Collaborators
Walter Reed Army Medical Center
Bureau of Navy Medicine (BUMED)
  More Information

No publications provided

Responsible Party: Thomas A Summers, Jr, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT01322750     History of Changes
Other Study ID Numbers: 354344
Study First Received: March 24, 2011
Last Updated: March 24, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Congenital Abnormalities
Breast Neoplasms
Carcinoma
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014