Carcinoma, Non-Small-Cell LungNCT02934360
TR(ACE) Assay Clinical Specimen Study
An observational study of Carcinoma, Non-Small-Cell Lung and Breast Neoplasms, run by Biological Dynamics at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
- What is being tested?
- TR(ACE) Assay Testing
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 450 participants
- Where
- 16 sitesUnited States
- Study dates
- Sep 2016to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites, 15 recruiting
- Withdrawn
Ashland Bellefonte Cancer Center
Ashland, Kentucky, 41101
- Recruiting
Indiana University Health Bloomington
Bloomington, Indiana, 47403
Mark Peabody, 812-353-2831, blm-clinicalresearch@iuhealth.org
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
Carrie Smith, 330-492-3345, csmith@gabrailcancercenter.com
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
North Shore Hematology Oncology
East Setauket, New York, 11733
Don Marx, 631-675-5143, dmarx@nycancer.com
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
California Cancer Associates for Reseach and Excellence, Inc. (cCare)
Encinitas, California, 92024
Joanna Garcia, 760-452-3909
Patsy Folio, 480-735-9035, patsy.folio@precisionformedicine.com
- Recruiting
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822
Kaitlyn Singer, 908-237-2330 ext. 3, ksinger@hhsnj.org
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
AnMed
Greenville, South Carolina, 29621
AnMed Health Oncology Research Office, 864-512-4650
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Krista Tibbs, 865-934-2676, ktibbs@biomed-research.com
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
North County Oncology Medical Inc. (North County)
Oceanside, California, 92056
Yumiko Kawai, 760-758-5770
Patsy Folio, 480-735-9035, patsy.folio@precisionformedicine.com
- Recruiting
Mid-Florida
Orange City, Florida, 32763
Prutha Patel, 407-921-3767, prutha@clorene.org
Patsy Folio, 480-735-9035, patsy.folio@precisionformedicine.com
- Recruiting
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
Joann Ackler, 215-456-8295, acklerj@einstein.edu
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
Michmer (Lake Huron Medical Center)
Port Huron, Michigan, 48060
Kathleen Fisher, RN, 810-216-1185, kfisher2@primehealthcare.com
Robert Langolf, 248-747-4383, robert.langolf@michmer.com
- Recruiting
John Wayne Cancer Institute
Santa Monica, California, 90404
Osita Onugha, MD, 310-829-8618, osita.onugha@providence.org
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
Community Medical Center
Toms River, New Jersey, 08755
Jonathan A Gapilango, RN MSN OCN CCRP, 732-557-8239, jonathan.gapilango@rwjbh.org
Patsy Folio, 240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
Tyler Hematology Oncology
Tyler, Texas, 75701
Perla Lopez, 903-595-7041, plopez@hopecancertexas.com
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
- Recruiting
Bond Clinic
Winter Haven, Florida, 33880
Nikki Branca, 863-293-1191, nbranca@bondclinic.com
Patsy Folio, 1-240-415-6022, patsy.folio@precisionformedicine.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
- Being tested
- TR(ACE) Assay Testing
- Keywords
- Lung Cancer, Breast Cancer, cell free DNA, biomarker
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR(ACE) Assay TestingDevice
Serial plasma testing with TR(ACE) Assay
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: TR(ACE) Assay Testing | |
| Breast Cancer | Previously diagnosed stage IV breast cancer subjects will provide serial plasma specimens and clinical assessment information over time. Receives: Device: TR(ACE) Assay Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment change
Standard of care physician's clinical assessment of disease progression or response compared to previous visit
Measured: Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months
Secondary outcomes (1)
RECIST 1.1 criteria
RECIST 1.1 criteria of subjects from current to previous visit
Measured: Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biological Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Kovelman, Study director, Biological Dynamics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934360
- Sponsor's protocol ID
- BioDyn-15-003
- Status last verified
- Jan 2018
- First submitted
- 13 Oct 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Following direct de novo submission, data will be summarized in decision summary and package insert
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02934360
- Acronym / sponsor ID
- BioDyn-15-003
- Conditions
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
- Keywords
- Lung Cancer, Breast Cancer, cell free DNA, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Biological DynamicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-small cell Lung Cancer | – | Device: TR(ACE) Assay TestingPreviously diagnosed stage III or higher non-small cell lung cancer subjects will provide serial plasma specimens and clinical assessment information over time |
| Breast Cancer | – | Device: TR(ACE) Assay TestingPreviously diagnosed stage IV breast cancer subjects will provide serial plasma specimens and clinical assessment information over time. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TR(ACE) Assay TestingSerial plasma testing with TR(ACE) Assay | Device | Breast Cancer, Non-small cell Lung Cancer |
Primary outcome
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
1 secondary outcome
RECIST 1.1 criteria
Time frame: Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: Yes. Following direct de novo submission, data will be summarized in decision summary and package insert
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 3
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
RecruitingPhase 3
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib
Lung Cancer
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Non-small Cell Lung Cancer (NSCLC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kovelman study director
Biological Dynamics
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung and Breast Neoplasms, run by Biological Dynamics at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patsy Folio (1-240-415-6022, patsy.folio@precisionformedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Assessment change (time frame: Standard of care (approximately every 6 weeks to 3 months) for 6- 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.