TR(ACE) Assay Clinical Specimen Study
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)
1 other identifier
observational
450
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedJanuary 18, 2018
January 1, 2018
1.3 years
October 13, 2016
January 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
RECIST 1.1 criteria
Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months
Study Arms (2)
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
Breast Cancer
Previously diagnosed stage IV breast cancer subjects will provide serial plasma specimens and clinical assessment information over time.
Interventions
Serial plasma testing with TR(ACE) Assay
Eligibility Criteria
Previously diagnosed non-small cell lung cancer subjects undergoing standard of care treatment Previously diagnosed breast cancer subjects undergoing standard of care treatment
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
California Cancer Associates for Reseach and Excellence, Inc. (cCare)
Encinitas, California, 92024, United States
North County Oncology Medical Inc. (North County)
Oceanside, California, 92056, United States
John Wayne Cancer Institute
Santa Monica, California, 90404, United States
Mid-Florida
Orange City, Florida, 32763, United States
Bond Clinic
Winter Haven, Florida, 33880, United States
Indiana University Health Bloomington
Bloomington, Indiana, 47403, United States
Ashland Bellefonte Cancer Center
Ashland, Kentucky, 41101, United States
Michmer (Lake Huron Medical Center)
Port Huron, Michigan, 48060, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
North Shore Hematology Oncology
East Setauket, New York, 11733, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
AnMed
Greenville, South Carolina, 29621, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Tyler Hematology Oncology
Tyler, Texas, 75701, United States
Biospecimen
Plasma specimens will be collected prospective and tested retrospectively
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Kovelman
Biological Dynamics
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2016
First Posted
October 17, 2016
Study Start
September 1, 2016
Primary Completion
January 1, 2018
Study Completion
April 1, 2018
Last Updated
January 18, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
Following direct de novo submission, data will be summarized in decision summary and package insert