Recruiting

Observational StudyTR(ACE) Assay Clinical Specimen Study

Sponsor:

Biological Dynamics

Code:

NCT02934360

Conditions

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

TR(ACE) Assay Testing

Study Details

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Study ID

NCT02934360

Start date

Sep, 2016

Status verified date

Jan, 2018

Completion date

Apr, 2018

Anticipated

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

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

TR(ACE) Assay Testing

Serial plasma testing with TR(ACE) Assay

Primary outcome measure

Clinical Assessment change [ Time Frame: Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months ]

Central Contacts and Locations

Central contacts

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Transis Clemons

1-240-415-6038 transis.clemons@precisionformedicine.com

Locations

California Cancer Associates for Reseach and Excellence, Inc. (cCare)

Recruiting

Encinitas, California, United States, 92024

Contacts

Joanna Garcia

760-452-3909

Patsy Folio

480-735-9035 patsy.folio@precisionformedicine.com

North County Oncology Medical Inc. (North County)

Recruiting

Oceanside, California, United States, 92056

Contacts

Yumiko Kawai

760-758-5770

Patsy Folio

480-735-9035 patsy.folio@precisionformedicine.com

John Wayne Cancer Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Osita Onugha, MD

310-829-8618 osita.onugha@providence.org

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

Osita Onugha, MD

Mid-Florida

Recruiting

Orange City, Florida, United States, 32763

Contacts

Prutha Patel

407-921-3767 prutha@clorene.org

Patsy Folio

480-735-9035 patsy.folio@precisionformedicine.com

Bond Clinic

Recruiting

Winter Haven, Florida, United States, 33880

Contacts

Nikki Branca

863-293-1191 nbranca@bondclinic.com

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

Osama Abu Hlalah, MD

Indiana University Health Bloomington

Recruiting

Bloomington, Indiana, United States, 47403

Contacts

Mark Peabody

812-353-2831 blm-clinicalresearch@iuhealth.org

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

Jeffery Allerton, MD

Michmer (Lake Huron Medical Center)

Recruiting

Port Huron, Michigan, United States, 48060

Contacts

Kathleen Fisher, RN

810-216-1185 kfisher2@primehealthcare.com

Robert Langolf

248-747-4383 robert.langolf@michmer.com

Principal Investigator:

Anup Lal, MD

Hunterdon Hematology Oncology

Recruiting

Flemington, New Jersey, United States, 08822

Contacts

Kaitlyn Singer

908-237-2330 ksinger@hhsnj.org

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

Waqas Rehman, MD

Community Medical Center

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Jonathan A Gapilango, RN MSN OCN CCRP

732-557-8239 jonathan.gapilango@rwjbh.org

Patsy Folio

240-415-6022 patsy.folio@precisionformedicine.com

North Shore Hematology Oncology

Recruiting

East Setauket, New York, United States, 11733

Contacts

Don Marx

631-675-5143 dmarx@nycancer.com

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

David Chu, MD

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

Contacts

Carrie Smith

330-492-3345 csmith@gabrailcancercenter.com

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

Nashat Gabrail, MD

Albert Einstein Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contacts

Joann Ackler

215-456-8295 acklerj@einstein.edu

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

William Tester, MD

AnMed

Recruiting

Greenville, South Carolina, United States, 29621

Contacts

AnMed Health Oncology Research Office

864-512-4650

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

John E Doster, MD

Tennessee Cancer Specialists

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Krista Tibbs

865-934-2676 ktibbs@biomed-research.com

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

Tracy Dobbs, MD

Tyler Hematology Oncology

Recruiting

Tyler, Texas, United States, 75701

Contacts

Perla Lopez

903-595-7041 plopez@hopecancertexas.com

Patsy Folio

1-240-415-6022 patsy.folio@precisionformedicine.com

Principal Investigator:

Arielle Lee, MD

More Information

Sponsor

Biological Dynamics

Last update posted

Jan 18, 2018

Last verified

Jan, 2018

Keywords

Lung Cancer
Breast Cancer
cell free DNA
biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Biological Dynamics on 2018-01-18.