TR(ACE) Assay Clinical Specimen Study

January 16, 2018 updated by: Biological Dynamics

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92024
        • Recruiting
        • California Cancer Associates for Reseach and Excellence, Inc. (cCare)
        • Contact:
        • Contact:
          • Joanna Garcia
          • Phone Number: 760-452-3909
      • Oceanside, California, United States, 92056
        • Recruiting
        • North County Oncology Medical Inc. (North County)
        • Contact:
        • Contact:
          • Yumiko Kawai
          • Phone Number: 760-758-5770
      • Santa Monica, California, United States, 90404
    • Florida
    • Indiana
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Withdrawn
        • Ashland Bellefonte Cancer Center
    • Michigan
      • Port Huron, Michigan, United States, 48060
    • New Jersey
    • New York
      • East Setauket, New York, United States, 11733
    • Ohio
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
    • South Carolina
      • Greenville, South Carolina, United States, 29621
        • Recruiting
        • AnMed
        • Contact:
        • Contact:
          • AnMed Health Oncology Research Office
          • Phone Number: 864-512-4650
        • Principal Investigator:
          • John E Doster, MD
    • Tennessee
    • Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biological Dynamics

Investigators

  • Study Director: Robert Kovelman, Biological Dynamics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BioDyn-15-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Following direct de novo submission, data will be summarized in decision summary and package insert

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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