TR(ACE) Assay Clinical Specimen Study



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:1/20/2018
Start Date:September 2016
End Date:April 2018
Contact:Patsy Folio
Email:patsy.folio@precisionformedicine.com
Phone:1-240-415-6022

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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)

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.

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.

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
We found this trial at
16
sites
4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Gabrail, MD
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
Principal Investigator: Osita Onugha, MD
Phone: 310-829-8618
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Winter Haven, Florida 33880
Principal Investigator: Osama Abu Hlalah, MD
Phone: 863-293-1191
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Ashland, Kentucky 41101
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Bloomington, Indiana 47403
Principal Investigator: Jeffery Allerton, MD
Phone: 812-353-2831
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East Setauket, New York 11733
Principal Investigator: David Chu, MD
Phone: 631-675-5143
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16918 Dove Canyon Road
Encinitas, California 92024
Phone: 760-452-3909
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Flemington, New Jersey 08822
Principal Investigator: Waqas Rehman, MD
Phone: 908-237-2330
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2000 East Greenville Street
Greenville, South Carolina 29621
Principal Investigator: John E Doster, MD
Phone: 864-512-4650
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Knoxville, Tennessee 37920
Principal Investigator: Tracy Dobbs, MD
Phone: 865-934-2676
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3601 Rancho Del Oro Drive
Oceanside, California 92056
Phone: 760-758-5770
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Orange City, Florida 32763
Phone: 407-921-3767
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Philadelphia, Pennsylvania 19141
Principal Investigator: William Tester, MD
Phone: 215-456-8295
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2601 Electric Avenue
Port Huron, Michigan 48060
Principal Investigator: Anup Lal, MD
Phone: 810-216-1185
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Toms River, New Jersey 08755
Phone: 732-557-8239
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Tyler, Texas 75701
Principal Investigator: Arielle Lee, MD
Phone: 903-595-7041
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