TR(ACE) Assay Clinical Specimen Study

Breast Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02934360
• Other study ID #: BioDyn-15-003
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2016
• Last updated: January 16, 2018
• Start date: September 2016
• Est. completion date: April 2018

Study information

• Verified date: January 2018
• Source: Biological Dynamics
• Contact: Patsy Folio
• Phone: 1-240-415-6022
• Email: patsy.folio[@]precisionformedicine.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: April 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• TR(ACE) Assay Testing
Serial plasma testing with TR(ACE) Assay

Locations

Country	Name	City	State
United States	Ashland Bellefonte Cancer Center	Ashland	Kentucky
United States	Indiana University Health Bloomington	Bloomington	Indiana
United States	Gabrail Cancer Center	Canton	Ohio
United States	North Shore Hematology Oncology	East Setauket	New York
United States	California Cancer Associates for Reseach and Excellence, Inc. (cCare)	Encinitas	California
United States	Hunterdon Hematology Oncology	Flemington	New Jersey
United States	AnMed	Greenville	South Carolina
United States	Tennessee Cancer Specialists	Knoxville	Tennessee
United States	North County Oncology Medical Inc. (North County)	Oceanside	California
United States	Mid-Florida	Orange City	Florida
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Michmer (Lake Huron Medical Center)	Port Huron	Michigan
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Community Medical Center	Toms River	New Jersey
United States	Tyler Hematology Oncology	Tyler	Texas
United States	Bond Clinic	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biological Dynamics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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