NCT02934360

TR(ACE) Assay Clinical Specimen Study

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Biological Dynamics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	TR(ACE) Assay Testing	Serial plasma testing with TR(ACE) Assay

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-01-01
• Completion: 2018-04-01
• First posted: 2016-10-17
• Last updated: 2018-01-18

Locations

16 sites across 1 country: United States