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NCT01617915 · ClinicalTrials.gov registry record
Tumor Specific Plasma DNA
A clinical trial, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- 6
- Enrollment target
NCT01617915: Completed study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT01617915 is a clinical trial that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01617915 has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- 6 participants
- Enrollment target
Study Summary
In 2011, there was an estimated 233,000 cases of invasive breast cancer, and 39,970 deaths from breast cancer in the United States. The vast majority of patients are diagnosed with Stage I-III resectable and potentially curable disease, and for these patients, the most pressing questions are whether adjuvant endocrine or chemotherapy are indicated, and if so, how to determine whether these treatments are working. Adjuvant systemic therapy reduces relative recurrence rates by 30-50%, depending on the age of the patient and tumor characteristics. However, patients with early stage disease often do not bear measurable markers of disease such as an elevated cancer antigen 27-29 (CA27.29) or circulating tumor cells. Patients with early stage breast cancer are typically treated with adjuvant therapy based on historical evidence showing that such therapy prolongs survival in this population. Lung cancer is the most common malignancy and the leading cause of cancer-related death in the U.S. Approximately 220,000 new cases of lung cancer are diagnosed in the U.S. every year. Unfortunately, lung cancers are often diagnosed at later stages than breast cancer, due in part to little/no effective screening for lung cancer. As with breast cancer, patients are commonly treated with chemotherapeutic agents, but treatment regimens can take several weeks to months to elicit clinically detectable anti-tumor effects. A biomarker to assess early tumor response to therapy would benefit this patient population. The contents of dying tumor cells can be detected in the bloodstream, and this may be enhanced by the leaky vasculature of solid tumors. Protein biomarkers of tumor cell death are difficult to detect due to the complex nature of plasma and the lack of technical sensitivity. In contrast, DNA is easier to detect through polymerase chain reaction (PCR) amplification. Indeed, circulating tumor DNA has been detected in plasma from patients with osteosarcoma, breast cancer, and colorect
Primary Outcome
To determine whether acute increases in the levels of circulating tumor DNA correlate with response to chemotherapy in patients with breast cancer.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-10 |
| Est. Completion | 2021-05-07 |
What the finished NCT01617915 record still lists
NCT01617915 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01617915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01617915 about?
NCT01617915 is a clinical study titled "Tumor Specific Plasma DNA". In 2011, there was an estimated 233,000 cases of invasive breast cancer, and 39,970 deaths from breast cancer in the United States. The vast majority of patients are diagnosed with Stage I-III resectable and potentially curable disease, and for these patients, the most pressing questions are whether...
What is the current status of trial NCT01617915?
This trial is currently completed. The enrollment target is 6 participants. The study started on 2012-10. Estimated completion is 2021-05-07.
Who is sponsoring clinical trial NCT01617915?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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