SCLCNCT03244904
Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment
An observational study of SCLC, run by Fujian Cancer Hospital.
Trial summary
Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant to give NGS(Next-generation Sequencing).One is according to the germline mutation data to screen susceptible gene in SCLC(Small… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- SCLC
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Jul 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: SCLC
Who may be able to join
- Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
- Life expectancy > 10 months
- Karnofsky Performance Status ≥ 70
- Diagnosis of histological or cytologically confirmed SCLC,
- Age ≥ 18 years
- Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.
Who cannot join
- Poor compliance, reluctant to undergo research medication, or follow-up.
- Tumor inaccessible for biopsy
- It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.
- It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: a Prospective Cohort Study for Small Cell Lung Cancer to Identify Susceptibility Gene and Assess DNA Dynamic Change by Next-generation Sequencing
Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant to give NGS(Next-generation Sequencing).One is according to the germline mutation data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the extensive consistency detection of blood and tissues in patients with SCLC gene mutation information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in patients with SCLC during treatment, by changing the types of mutations / abundance (for example: the clonal evolution of typical samples analysis) and change of tumor load, , investigating the patients treatment effect , for the significant change of mutations, to study whether it can be used as molecular marker; four is to analyze of the molecular typing of SCLC, according to the clinical and pathological features of patients.
- Conditions
- SCLC
- Keywords
- NGS,SCLC, ctDNA
What is being measured
The primary outcome is the main question the study is designed to answer.
susceptibility gene site of small cell lung cancer
searching susceptibility gene site of small cell lung cancer according to germline mutation data
Measured: 01.11.2017-31.05.2018
Secondary outcomes (1)
consistency of ctDNA and tDNA sequencing results in patients with SCLC
explore consistency of ctDNA and tDNA sequencing results in patients with ESCLC
Measured: 01.11.2017-31.05.2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study startNov 2017 (estimated)
- Primary completionNov 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLCStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gen Lin, MD,PhD, Principal investigator, CSWOG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244904
- Sponsor's protocol ID
- CSWOG01
- Status last verified
- Jul 2017
- First submitted
- 5 Aug 2017
- Last updated
- 10 Aug 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Prospective Cohort Study for Small Cell Lung Cancer to Identify Susceptibility Gene and Assess DNA Dynamic Change by Next-generation Sequencing
- ClinicalTrials.gov ID
- NCT03244904
- Acronym / sponsor ID
- CSWOG01
- Conditions
- SCLC
- Keywords
- NGS,SCLC, ctDNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Nov 2017 (estimated)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 10 Aug 2017 (actual)
- 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.
Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant to give NGS(Next-generation Sequencing).One is according to the germline mutation data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the extensive consistency detection of blood and tissues in patients with SCLC gene mutation information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in patients with SCLC during treatment, by changing the types of mutations / abundance (for example: the clonal evolution of typical samples analysis) and change of tumor load, , investigating the patients treatment effect , for the significant change of mutations, to study whether it can be used as molecular marker; four is to analyze of the molecular typing of SCLC, according to the clinical and pathological features of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- SCLC
Key inclusion criteria (6 listed)
- Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
- Life expectancy > 10 months
- Karnofsky Performance Status ≥ 70
- Diagnosis of histological or cytologically confirmed SCLC,
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Poor compliance, reluctant to undergo research medication, or follow-up.
- Tumor inaccessible for biopsy
- It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.
- It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.
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
susceptibility gene site of small cell lung cancer
Time frame: 01.11.2017-31.05.2018
searching susceptibility gene site of small cell lung cancer according to germline mutation data
1 secondary outcome
consistency of ctDNA and tDNA sequencing results in patients with SCLC
Time frame: 01.11.2017-31.05.2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- 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.
Gen Lin, MD,PhD principal investigator
CSWOG
Questions about this trial
What is this clinical trial studying?
An observational study of SCLC, run by Fujian Cancer 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 6 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: status not confirmed, as of the sponsor's last update on 10 Aug 2017. 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?
Contact Gen Lin, MD,PhD (008613313786157, lingen197505@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
susceptibility gene site of small cell lung cancer (time frame: 01.11.2017-31.05.2018). 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 10 Aug 2017.