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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biological Dynamics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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