Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Lung Cancer, Breast Cancer, cell free DNA, biomarker
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.
Interventions
DEVICETR(ACE) Assay Testing
Serial plasma testing with TR(ACE) Assay
Sponsors
Biological Dynamics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactPatsy Folio
Backup ContactTransis Clemons
Outcome results
None listed