Breast Abnormality Clinical Trial
Official title:
Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma
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.
| Status | Recruiting |
| Enrollment | 3125 |
| Est. completion date | January 2023 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Walter Reed Army Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Walter Reed Army Medical Center | Bureau of Navy Medicine (BUMED) |
United States,