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Trial record 1 of 1 for:    NCT02934360
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TR(ACE) Assay Clinical Specimen Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Biological Dynamics
Information provided by (Responsible Party):
Biological Dynamics Identifier:
First received: October 13, 2016
Last updated: April 2, 2017
Last verified: April 2017
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.

Condition Intervention
Carcinoma, Non-Small-Cell Lung
Breast Neoplasms
Device: TR(ACE) Assay Testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Biological Dynamics:

Primary Outcome Measures:
  • Clinical Assessment change [ Time Frame: 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 Outcome Measures:
  • RECIST 1.1 criteria [ Time Frame: 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

Biospecimen Retention:   Samples With DNA
Plasma specimens will be collected prospective and tested retrospectively

Estimated Enrollment: 450
Study Start Date: September 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-small cell Lung Cancer
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
Serial plasma testing with TR(ACE) Assay
Breast Cancer
Previously diagnosed stage IV breast cancer subjects will provide serial plasma specimens and clinical assessment information over time.
Device: TR(ACE) Assay Testing
Serial plasma testing with TR(ACE) Assay

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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously diagnosed non-small cell lung cancer subjects undergoing standard of care treatment Previously diagnosed breast cancer subjects undergoing standard of care treatment

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02934360

Contact: Patsy Folio 1-240-415-6022
Contact: Transis Clemons 1-240-415-6038

United States, California
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Osita Onugha, MD    310-829-8618   
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: Osita Onugha, MD         
United States, Florida
Bond Clinic Recruiting
Winter Haven, Florida, United States, 33880
Contact: Nikki Branca    863-293-1191   
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: Osama Abu Hlalah, MD         
United States, Indiana
Indiana University Health Bloomington Recruiting
Bloomington, Indiana, United States, 47403
Contact: Mark Peabody    812-353-2831   
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: Jeffery Allerton, MD         
United States, Kentucky
Ashland Bellefonte Cancer Center Recruiting
Ashland, Kentucky, United States, 41101
Contact: Asheesh Jain    606-836-0202   
Contact: Patsy Folio    240-415-6022   
Principal Investigator: Kirti Jain, MD         
United States, Michigan
Michmer (Lake Huron Medical Center) Recruiting
Port Huron, Michigan, United States, 48060
Contact: Kathleen Fisher, RN    810-216-1185   
Contact: Robert Langolf    248-747-4383   
Principal Investigator: Anup Lal, MD         
United States, New Jersey
Hunterdon Hematology Oncology Recruiting
Flemington, New Jersey, United States, 08822
Contact: Kaitlyn Singer    908-237-2330 ext 3   
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: Waqas Rehman, MD         
Community Medical Center Recruiting
Toms River, New Jersey, United States, 08755
Contact: Jonathan A Gapilango, RN MSN OCN CCRP    732-557-8239   
Contact: Patsy Folio    240-415-6022   
United States, New York
North Shore Hematology Oncology Recruiting
East Setauket, New York, United States, 11733
Contact: Don Marx    631-675-5143   
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: David Chu, MD         
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Contact: Carrie Smith    330-492-3345   
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: Nashat Gabrail, MD         
United States, Pennsylvania
Albert Einstein Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Joann Ackler    215-456-8295   
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: William Tester, MD         
United States, South Carolina
AnMed Recruiting
Greenville, South Carolina, United States, 29621
Contact: AnMed Health Oncology Research Office    864-512-4650      
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: John E Doster, MD         
United States, Tennessee
Tennessee Cancer Specialists Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Krista Tibbs    865-934-2676   
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: Tracy Dobbs, MD         
United States, Texas
Tyler Hematology Oncology Recruiting
Tyler, Texas, United States, 75701
Contact: Perla Lopez    903-595-7041   
Contact: Patsy Folio    1-240-415-6022   
Principal Investigator: Arielle Lee, MD         
Sponsors and Collaborators
Biological Dynamics
Study Director: Robert Kovelman Biological Dynamics
  More Information

Responsible Party: Biological Dynamics Identifier: NCT02934360     History of Changes
Other Study ID Numbers: BioDyn-15-003
Study First Received: October 13, 2016
Last Updated: April 2, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Following direct de novo submission, data will be summarized in decision summary and package insert

Keywords provided by Biological Dynamics:
Lung Cancer
Breast Cancer
cell free DNA

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases processed this record on May 25, 2017