Clinical trial NCT02934360: TR(ACE) Assay Clinical Specimen Study
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Breast Neoplasms
Keywords: Lung Cancer
Breast Cancer
cell free DNA
biomarker
Lead sponsor: Biological Dynamics
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Assessment change
timeFrame: Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months
Secondary outcomes:
measure: RECIST 1.1 criteria
timeFrame: Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: California Cancer Associates for Reseach and Excellence, Inc. (cCare)
state: California
city: Oceanside
country: United States
facility: North County Oncology Medical Inc. (North County)
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Orange City
country: United States
facility: Mid-Florida
state: Florida
city: Winter Haven
country: United States
facility: Bond Clinic
state: Florida
city: Bloomington
country: United States
facility: Indiana University Health Bloomington
state: Indiana
city: Ashland
country: United States
facility: Ashland Bellefonte Cancer Center
state: Kentucky
city: Port Huron
country: United States
facility: Michmer (Lake Huron Medical Center)
state: Michigan
city: Flemington
country: United States
facility: Hunterdon Hematology Oncology
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: East Setauket
country: United States
facility: North Shore Hematology Oncology
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: AnMed
state: South Carolina
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Tyler
country: United States
facility: Tyler Hematology Oncology
state: Texas
Study officials:
affiliation: Biological Dynamics
name: Robert Kovelman
role: STUDY_DIRECTOR
References: