TR(ACE) Assay Clinical Specimen Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the TR(ACE) Assay for the Ability to Aid in Monitoring Disease Progress, Response to Therapy or for Recurrent or Residual Disease for Patients With Previously Diagnosed Cancers (Stage III and IV Lung and Stage IV Breast)

Conditions
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Carcinoma, Non-Small-Cell Lung, Breast Neoplasms

Intervention / Treatment
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* Device: TR(ACE) Assay Testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-small cell Lung Cancer<br>Previously diagnosed stage III or higher non-small cell lung cancer subjects will provide serial plasma specimens and clinical assessment information over time | Device: TR(ACE) Assay Testing<br>* Serial plasma testing with TR(ACE) Assay<br>|
| Breast Cancer<br>Previously diagnosed stage IV breast cancer subjects will provide serial plasma specimens and clinical assessment information over time. | Device: TR(ACE) Assay Testing<br>* Serial plasma testing with TR(ACE) Assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Assessment change | Standard of care physician's clinical assessment of disease progression or response compared to previous visit | Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RECIST 1.1 criteria | RECIST 1.1 criteria of subjects from current to previous visit | Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Breast Cancer, cell free DNA, biomarker