Cancer of the LungNCT02715102
Circulating Tumor DNA in Patients at High Risk for Lung Cancer
An observational study of Cancer of the Lung and Lung Cancer, run by Pathway Genomics at 1 site in United States.
Trial summary
Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic surgery without a distant history of cancer will have their blood drawn for measurement of circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the early detection of lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Lung, Lung Cancer, Lung Neoplasms
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled to undergo a diagnostic or therapeutic bronchoscopy or thoracotomy by Dr. Robert McKenna.
Who may be able to join
- 18 years of age or older, not previously diagnosed with cancer (except for basal cell carcinomas of the skin or a diagnosis of cancer within a month of surgery and for which the surgical procedure is being performed).
Who cannot join
- Prior history of cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiothoracic Outpatient Clinic, Providence Saint John's Health Center, 2121 Santa Monica Blvd.
Santa Monica, California, 90404
About this study
Official title: Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for Detection of Lung Cancer in Patients Undergoing Diagnostic or Therapeutic Bronchoscopy or Thoracotomy
Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic surgery without a distant history of cancer will have their blood drawn for measurement of circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the early detection of lung cancer.
Read the detailed description
Specific somatic (i.e. acquired and not inherited) mutations have been found in many cancers. Some of these cancers shed this DNA into the patient's blood stream and is called circulating tumor DNA (ctDNA). Pathway Genomics has developed a new molecular assay that uses blood plasma as the source of DNA fragments. The ctDNA is isolated, amplified and analyzed for the presence of one or more of 96 known mutations that are found in 9 cancer driver genes. This technique of using a "liquid biopsy" to screen for and monitor cancer has been documented in a number of recent medical publications. However, the majority of published studies are on subjects who have already been diagnosed with cancer. Therefore, the investigators wish to look at a population of patients who are scheduled to undergo a diagnostic or therapeutic bronchoscopy or thoracotomy without a know history of cancer (other than basal cell carcinomas of the skin). The blood will be drawn at the time of or a few weeks before the procedure. The analysis of the blood sample will take placed in the Pathway Genomics clinical laboratory which is Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified.
Following an informed consent process, the patients will fill out a health questionnaire and will have the blood drawn prior to the surgical procedure. Up to 30 ml of blood (approximately 2 tablespoons) will be drawn at any one time. The patient will be asked to agree to being contacted by the investigators yearly for up to 5 years to provide follow-up medical information. No patient will be identified in presentations or publications resulting from this work and all data will be reported from analysis of combined information from participants in this study.
Individuals may participate in this study if they are 18 years of age or older, have not had a prior diagnosis of cancer (other than a skin cancer or if they are undergoing the thoracic surgical procedure for a cancer that was diagnosed within the prior month), and are undergoing a diagnostic or therapeutic bronchoscopy or thoracotomy.
- Conditions
- Cancer of the Lung, Lung Cancer, Lung Neoplasms, Adenocarcinoma of the Lung, Non Small Cell Carcinoma of the Lung, Small Cell Carcinoma of the Lung
- Keywords
- lung cancer, lung neoplasms, lung nodules, screening tests for cancer
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with lung cancer who had a positive ctDNA result (true positive)
ctDNA results will be correlated with pathology and subsequent clinical findings.
Measured: 5 years
Secondary outcomes (4)
Percentage of patients who develop any cancer during the 5 years of follow-up
ctDNA results will be correlated with pathology and subsequent clinical findings.
Measured: 5 years
Percentage of patients without lung cancer who had a positive ctDNA result (false positive)
ctDNA results will be correlated with pathology and subsequent clinical findings.
Measured: 5 years
Percentage of patients with lung cancer who had a negative ctDNA result (false negative)
ctDNA results will be correlated with pathology and subsequent clinical findings.
Measured: 5 years
Percentage of patients without lung cancer who had a negative ctDNA result (true negative)
ctDNA results will be correlated with pathology and subsequent clinical findings.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Patient accrual was slow due to exclusion of patients with prior cancers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathway Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert J. McKenna, M.D., Principal investigator, Providence Saint John's Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715102
- Sponsor's protocol ID
- Pathway Genomics - 006
- Status last verified
- Aug 2017
- First submitted
- 14 Mar 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Through presentations at scientific meetings and in the peer-reviewed medical literature.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for Detection of Lung Cancer in Patients Undergoing Diagnostic or Therapeutic Bronchoscopy or Thoracotomy
- ClinicalTrials.gov ID
- NCT02715102
- Acronym / sponsor ID
- Pathway Genomics - 006
- Conditions
- Cancer of the Lung, Lung Cancer, Lung Neoplasms, Adenocarcinoma of the Lung, Non Small Cell Carcinoma of the Lung, Small Cell Carcinoma of the Lung
- Keywords
- lung cancer, lung neoplasms, lung nodules, screening tests for cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patient accrual was slow due to exclusion of patients with prior cancers
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Pathway GenomicsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Mar 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.
Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic surgery without a distant history of cancer will have their blood drawn for measurement of circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the early detection of lung cancer.
Detailed description
Specific somatic (i.e. acquired and not inherited) mutations have been found in many cancers. Some of these cancers shed this DNA into the patient's blood stream and is called circulating tumor DNA (ctDNA). Pathway Genomics has developed a new molecular assay that uses blood plasma as the source of DNA fragments. The ctDNA is isolated, amplified and analyzed for the presence of one or more of 96 known mutations that are found in 9 cancer driver genes. This technique of using a "liquid biopsy" to screen for and monitor cancer has been documented in a number of recent medical publications. However, the majority of published studies are on subjects who have already been diagnosed with cancer. Therefore, the investigators wish to look at a population of patients who are scheduled to undergo a diagnostic or therapeutic bronchoscopy or thoracotomy without a know history of cancer (other than basal cell carcinomas of the skin). The blood will be drawn at the time of or a few weeks before the procedure. The analysis of the blood sample will take placed in the Pathway Genomics clinical laboratory which is Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified.
Following an informed consent process, the patients will fill out a health questionnaire and will have the blood drawn prior to the surgical procedure. Up to 30 ml of blood (approximately 2 tablespoons) will be drawn at any one time. The patient will be asked to agree to being contacted by the investigators yearly for up to 5 years to provide follow-up medical information. No patient will be identified in presentations or publications resulting from this work and all data will be reported from analysis of combined information from participants in this study.
Individuals may participate in this study if they are 18 years of age or older, have not had a prior diagnosis of cancer (other than a skin cancer or if they are undergoing the thoracic surgical procedure for a cancer that was diagnosed within the prior month), and are undergoing a diagnostic or therapeutic bronchoscopy or thoracotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled to undergo a diagnostic or therapeutic bronchoscopy or thoracotomy by Dr. Robert McKenna.
Key inclusion criteria (1 listed)
- 18 years of age or older, not previously diagnosed with cancer (except for basal cell carcinomas of the skin or a diagnosis of cancer within a month of surgery and for which the surgical procedure is being performed).
Key exclusion criteria (1 listed)
- Prior history of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with lung cancer who had a positive ctDNA result (true positive)
Time frame: 5 years
ctDNA results will be correlated with pathology and subsequent clinical findings.
4 secondary outcomes
Percentage of patients who develop any cancer during the 5 years of follow-up
Time frame: 5 years
Percentage of patients without lung cancer who had a positive ctDNA result (false positive)
Time frame: 5 years
Percentage of patients with lung cancer who had a negative ctDNA result (false negative)
Time frame: 5 years
Percentage of patients without lung cancer who had a negative ctDNA result (true negative)
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Patient accrual was slow due to exclusion of patients with prior cancers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Individual participant dataSharing planned: Yes. Through presentations at scientific meetings and in the peer-reviewed medical literature.
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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 J. McKenna, M.D. principal investigator
Providence Saint John's Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Lung and Lung Cancer, run by Pathway Genomics at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Patient accrual was slow due to exclusion of patients with prior cancers). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with lung cancer who had a positive ctDNA result (true positive) (time frame: 5 years). 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 21 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.