Carcinoma, Non-Small-Cell LungNCT02645318
Comparison of Circulating Tumor DNA and Tumor Tissue DNA by Targeted Sequencing in Non-Small Cell Lung Cancer
An observational study of Carcinoma, Non-Small-Cell Lung, run by Peking University People's Hospital at 1 site in China.
Trial summary
Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via targeted DNA sequencing in surgical NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Jul 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive cases who were suspected of non-small cell lung cancer and underwent curative-intent resection.
Who may be able to join
- Patient who is confirmed primary lung cancer by frozen pathologic histology
- Both the fresh tissue tumor and plasma samples are collected for analysis
Who cannot join
- Patients who received any treatment prior to resection
- Patients who have a history of malignancy
- Paraffin embedded section confirmed small cell lung cancer or unclassified carcinoma
- Tumor specimens where insufficient DNA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of Circulating Tumor DNA Detection by Targeted Sequencing in Surgical Non-Small Cell Lung Cancer Patients
Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via targeted DNA sequencing in surgical NSCLC patients.
Read the detailed description
Previous studies have shown the feasibility of detecting mutation status by circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no clinical standard method has been established, and most previous studies were lack of prospective clinical data and aimed at advanced NSCLC.
We plan to perform a prospective study including consecutive cases of NSCLC patients who underwent surgical treatments. Primary tumor and plasma samples were collected in each patients and gene mutation analysis were performed immediately after surgery. We utilized the targeted DNA sequencing with a next-generation sequencing (NGS) platform to detect driver somatic mutations in matched tumor DNA (tDNA) and plasma ctDNA samples with matched white blood cell (WBC) DNA as a control. A panel of genes were identified.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Circulating Tumor DNA, Lung cancer, Targeted sequencing
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample
Measured: 2-3 months
Secondary outcomes (4)
Concordance of tDNA and plasma ctDNA gene detection in early stage non-small cell lung cancer
Measured: 2-3months
Correlation of ctDNA concentration with clinical features
Measured: 2-3months
Comparison of positive predictive value between ctDNA and tumor markers
Measured: 2-3months
The relationship between ctDNA concentration and disease free survival(DFS）
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
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.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
- Investigators
- Kezhong Chen, M.D., Principal investigator, Peking University People's HospitalJun Wang, M.D., Study chair, Peking University People's HospitalFeng Lou, Study director, San Valley Biotechnology Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645318
- Sponsor's protocol ID
- PTHO1501
- Status last verified
- Dec 2015
- First submitted
- 30 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Circulating Tumor DNA Detection by Targeted Sequencing in Surgical Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02645318
- Acronym / sponsor ID
- PTHO1501
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Circulating Tumor DNA, Lung cancer, Targeted sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Jan 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.
Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via targeted DNA sequencing in surgical NSCLC patients.
Detailed description
Previous studies have shown the feasibility of detecting mutation status by circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no clinical standard method has been established, and most previous studies were lack of prospective clinical data and aimed at advanced NSCLC.
We plan to perform a prospective study including consecutive cases of NSCLC patients who underwent surgical treatments. Primary tumor and plasma samples were collected in each patients and gene mutation analysis were performed immediately after surgery. We utilized the targeted DNA sequencing with a next-generation sequencing (NGS) platform to detect driver somatic mutations in matched tumor DNA (tDNA) and plasma ctDNA samples with matched white blood cell (WBC) DNA as a control. A panel of genes were identified.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive cases who were suspected of non-small cell lung cancer and underwent curative-intent resection.
Key inclusion criteria (2 listed)
- Patient who is confirmed primary lung cancer by frozen pathologic histology
- Both the fresh tissue tumor and plasma samples are collected for analysis
Key exclusion criteria (4 listed)
- Patients who received any treatment prior to resection
- Patients who have a history of malignancy
- Paraffin embedded section confirmed small cell lung cancer or unclassified carcinoma
- Tumor specimens where insufficient DNA
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
Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample
Time frame: 2-3 months
4 secondary outcomes
Concordance of tDNA and plasma ctDNA gene detection in early stage non-small cell lung cancer
Time frame: 2-3months
Correlation of ctDNA concentration with clinical features
Time frame: 2-3months
Comparison of positive predictive value between ctDNA and tumor markers
Time frame: 2-3months
The relationship between ctDNA concentration and disease free survival(DFS）
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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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.
Kezhong Chen, M.D. principal investigator
Peking University People's Hospital
Jun Wang, M.D. study chair
Peking University People's Hospital
Feng Lou study director
San Valley Biotechnology Incorporated
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 Carcinoma, Non-Small-Cell Lung, run by Peking University People's Hospital at 1 site in China.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jan 2016. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample (time frame: 2-3 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 1 Jan 2016.