CarcinomaNCT02833467
Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA
An observational study of Carcinoma and Non-small-cell Lung Cancer, run by Peking University People's Hospital.
Trial summary
Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small-cell Lung Cancer, Thoracic Neoplasms
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2021
- 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: Multiple or multifocal primary lung cancer patients who underwent surgery
Who may be able to join
- Patients must have given written informed consent
- Histopathologically confirmed NSCLC
- Considered multiple or multifocal primary lung cancer by clinical criteria
Who cannot join
- Malignant tumor history within the past 5 years
- Patients who received any treatment prior to resection
- Insufficient tumor tissue or blood sample
About this study
Official title: A Prospective Study of Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA
Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients
Read the detailed description
Tumor samples originating from clinically considered multiple or multifocal primary lung cancer patients were available for mutational analysis. DNA and RNA were extracted from fresh tumor tissue or formalin-fixed, paraffin-embedded (FFPE) tissue. A series of cancer-related genomic alterations including single nucleotide variations (SNVs), short insertions and deletions (InDels), copy number variations (CNVs) and gene rearrangements were identified by a comprehensive NGS Panal . High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).
- Conditions
- Carcinoma, Non-small-cell Lung Cancer, Thoracic Neoplasms
- Keywords
- Circulating Tumor DNA, Heterogeneous, Multiple primary lung cancer
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung, Thoracic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing
Measured: 18 months
Secondary outcomes (3)
The concordant and discordant frequency of genomic results between tumor tissue and circulating tumor DNA in multiple primary lung cancer patients
Measured: 18 months
The relationship between disease free survival and genomic results in multiple primary lung cancer patients
Measured: 5 years
The relationship between overall survival and genomic results in multiple primary lung cancer patients
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 posted14 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- San Valley Biotechnology Incorporated
- Responsible party
- Principal investigator, Chen KeZhong, Peking University People's Hospital
- Investigators
- Kezhong Chen, M.D., Principal investigator, Peking University People's HospitalJun Wang, M.D., Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833467
- Sponsor's protocol ID
- PTHO1502
- Status last verified
- Aug 2019
- First submitted
- 9 Jul 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA
- ClinicalTrials.gov ID
- NCT02833467
- Acronym / sponsor ID
- PTHO1502
- Conditions
- Carcinoma, Non-small-cell Lung Cancer, Thoracic Neoplasms
- Keywords
- Circulating Tumor DNA, Heterogeneous, Multiple primary lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- San Valley Biotechnology Incorporated
- Study start
- Jan 2015
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 14 Jul 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.
Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients
Detailed description
Tumor samples originating from clinically considered multiple or multifocal primary lung cancer patients were available for mutational analysis. DNA and RNA were extracted from fresh tumor tissue or formalin-fixed, paraffin-embedded (FFPE) tissue. A series of cancer-related genomic alterations including single nucleotide variations (SNVs), short insertions and deletions (InDels), copy number variations (CNVs) and gene rearrangements were identified by a comprehensive NGS Panal . High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple or multifocal primary lung cancer patients who underwent surgery
Key inclusion criteria (3 listed)
- Patients must have given written informed consent
- Histopathologically confirmed NSCLC
- Considered multiple or multifocal primary lung cancer by clinical criteria
Key exclusion criteria (3 listed)
- Malignant tumor history within the past 5 years
- Patients who received any treatment prior to resection
- Insufficient tumor tissue or blood sample
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
The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing
Time frame: 18 months
3 secondary outcomes
The concordant and discordant frequency of genomic results between tumor tissue and circulating tumor DNA in multiple primary lung cancer patients
Time frame: 18 months
The relationship between disease free survival and genomic results in multiple primary lung cancer patients
Time frame: 5 years
The relationship between overall survival and genomic results in multiple primary lung cancer patients
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma and Non-small-cell Lung Cancer, run by Peking University People's Hospital.
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 3 inclusion and 3 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing (time frame: 18 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 28 Aug 2019.