TR(ACE) Assay Clinical Specimen Study
- Conditions
- Carcinoma, Non-Small-Cell LungBreast Neoplasms
- Interventions
- Device: TR(ACE) Assay Testing
- Registration Number
- NCT02934360
- Lead Sponsor
- Biological Dynamics
- Brief Summary
The TR(ACE) Assay is a quantitative in vitro diagnostic test run on the TR(ACE) Instrument intended for the measurement of high molecular weight human DNA from plasma as an aid to monitoring disease progression or response to therapy or recurrent or residual disease.
- Detailed Description
This study is to establish the clinical performance of the TR(ACE) Assay. Deltas of serial TR(ACE) Assay measurements will be compared to the standard of care physician clinical assessment and RECIST 1.1 criteria evaluation relative to the previous visit. Significant changes in serial TR(ACE) Assay measurements are hypothesized to correlate with disease progression or response.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
- Non-small cell lung: Male or Female Adult patient >= 21 years old
- Breast only: Female Adult patient >= 21 years old
- Previously diagnosed with one of the following cancers:
Breast or Non-small Cell Lung
- Cancer has progressed to at least Stage III or higher for lung cancer or,
- Cancer has progressed to stage IV (metastatic) breast cancer
- Participating in standard of care cancer therapy requiring frequent treatments, typically intravenous chemotherapy visits (or as determined by the standard of care for the particular cancer assessed), of a minimum of three (3) treatment visits planned in 9 months from date of enrollment where a clinical assessment will be conducted
- Physician assessment that obtaining two extra whole blood specimens with minimum volume of 5 mL per treatment visit is contraindicated
- Stage I and II Non-small Cell Lung Cancer
- Stage I through III breast cancer
- Pregnant or planning to become pregnant during the course of the study
- Unable to obtain informed consent from subject or their legal representative
- Life expectancy is less than 9 months
- Presence of one or more of the following other chronic diseases
- Another type of cancer except for non-melanomatous skin tumors
- Autoimmune disease requiring DMARDS or Biologics
- Infectious disease requiring prolonged intravenous antibiotics or hospitalization
- Renal disease specifically those in End Stage Renal Failure
- Recent (< 3 weeks) major trauma or major surgical procedure(s) or radiation therapy prior to enrollment in the study
- Recent (< 2 months) major occlusive arterial event such as MI or CVA prior to enrollment in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-small cell Lung Cancer TR(ACE) Assay Testing Previously diagnosed stage III or higher non-small cell lung cancer subjects will provide serial plasma specimens and clinical assessment information over time Breast Cancer TR(ACE) Assay Testing Previously diagnosed stage IV breast cancer subjects will provide serial plasma specimens and clinical assessment information over time.
- Primary Outcome Measures
Name Time Method Clinical Assessment change Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months Standard of care physician's clinical assessment of disease progression or response compared to previous visit
- Secondary Outcome Measures
Name Time Method RECIST 1.1 criteria Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months RECIST 1.1 criteria of subjects from current to previous visit
Trial Locations
- Locations (16)
California Cancer Associates for Reseach and Excellence, Inc. (cCare)
🇺🇸Encinitas, California, United States
North County Oncology Medical Inc. (North County)
🇺🇸Oceanside, California, United States
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Mid-Florida
🇺🇸Orange City, Florida, United States
Bond Clinic
🇺🇸Winter Haven, Florida, United States
Indiana University Health Bloomington
🇺🇸Bloomington, Indiana, United States
Ashland Bellefonte Cancer Center
🇺🇸Ashland, Kentucky, United States
Hunterdon Hematology Oncology
🇺🇸Flemington, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
North Shore Hematology Oncology
🇺🇸East Setauket, New York, United States
AnMed
🇺🇸Greenville, South Carolina, United States
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Tyler Hematology Oncology
🇺🇸Tyler, Texas, United States
Michmer (Lake Huron Medical Center)
🇺🇸Port Huron, Michigan, United States