TR(ACE) Assay Clinical Specimen Study

Status unconfirmed

Conditions studied: Carcinoma, Non-Small-Cell Lung, Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT02934360

Run by

Biological Dynamics

People needed

450

Starts

2016-09-01

Expected to finish

2018-04-01

Last updated by the study team

2018-01-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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