TR(ACE) Assay Clinical Specimen Study
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 18, 2018 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Biological Dynamics
- Interventions being studied
- Device: TR(ACE) Assay Testing
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- California Cancer Associates for Reseach and Excellence, Inc. (cCare)Encinitas, California
- North County Oncology Medical Inc. (North County)Oceanside, California
- John Wayne Cancer InstituteSanta Monica, California
- Mid-FloridaOrange City, Florida
- Bond ClinicWinter Haven, Florida
- Indiana University Health BloomingtonBloomington, Indiana
- Ashland Bellefonte Cancer CenterAshland, Kentucky
- Michmer (Lake Huron Medical Center)Port Huron, Michigan
- Hunterdon Hematology OncologyFlemington, New Jersey
- Community Medical CenterToms River, New Jersey
- North Shore Hematology OncologyEast Setauket, New York
- Gabrail Cancer CenterCanton, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 18, 2018. Always confirm current availability with the study team.