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UNKNOWNNCT02934360

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 p...

Lead sponsor: Biological Dynamics•16 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Patsy Folio

CONTACT

1-240-415-6022 patsy.folio@precisionformedicine.com

Transis Clemons

CONTACT

1-240-415-6038 transis.clemons@precisionformedicine.com

Sponsors

Lead Sponsor

Biological Dynamics

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.

Age

21 - No limit years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 18, 2018Terms

Trial snapshot

StatusUNKNOWN

Phase—

Enrollment450

Start dateSep 2016

Last updatedJan 18, 2018

Condition

Carcinoma, Non-Small-Cell Lung Breast Neoplasms

Locations shown

California Cancer Associates for Reseach and Excellence, Inc. (cCare)

Encinitas, California

North County Oncology Medical Inc. (North County)

Oceanside, California

John Wayne Cancer Institute

Santa Monica, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2018Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions