Lung CancerNCT03234179
A Prognosis and Predicting Genetic Study of Lung Cancer
An observational study of Lung Cancer and Genetic Predisposition to Disease, run by National Taiwan University Hospital.
Trial summary
Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence rates of lung cancer among never smoking females in some parts of East Asia are among the highest in the world. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer, Genetic Predisposition to Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Aug 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of primary non small cell lung cancer
Who may be able to join
- The patient's family (within third-degree relatives) has at least one diagnosed of primary non-small cell lung cancer.
- The patient was diagnosed of primary non-small cell lung cancer at the age < 45 years old.
Who cannot join
- Patients without the diagnosis of primary non-small cell lung cancer.
- Patients who are combined with other malignancy and ongoing chemotherapy / radiation therapy.
- Patients combined with coagulopathy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence rates of lung cancer among never smoking females in some parts of East Asia are among the highest in the world. The adenocarcinoma of lung being the most frequently identified histological type is more weakly associated with smoking, and often occurs in females and never-smokers. Although family history of lung cancer has been associated with histological subtypes, the inherited susceptibility factors that affect specific histology are unknown.
Genetic factors that determine individual predisposition to lung cancer have been identified via genome-wide association studies. These known common loci, however, explain only a small fraction of the familial risk of lung cancer. The hypothesis of this study is that there are genetic factors that confer inherited susceptibility among patients with primary non-small-cell lung cancer (NSCLC).
Read the detailed description
To delineate the genetic etiology underlying NSCLC, this study proposes to employ a family-based linkage analysis, together with rich data generated from NGS, to search for disease susceptibility locus for the patients with strong family history of primary NSCLC. By using family pedigrees, linkage analysis will be able to find co-segregation of alleles through multiple generations at a genetic susceptibility locus and a known genetic marker, and then the highly penetrate gene loci may be detected by our study. These gene loci will be a good genetic predictor of NSCLC which should be a great advantage in treatment, prevention and screening of NSCLC in the future.
- Conditions
- Lung Cancer, Genetic Predisposition to Disease
- Keywords
- Non small cell lung cancer, Genetic study
- Medical subject headings
- Lung Neoplasms, Genetic Predisposition to Disease, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic information of lung cancer patients
Collect study subjects' blood sample and analysis with Genome-wide SNP genotyping
Measured: One week after the study subjects sign the permit of informed consents
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Shing Chen, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234179
- Sponsor's protocol ID
- 201705110RIND
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prognosis and Predicting Genetic Study of Lung Cancer
- ClinicalTrials.gov ID
- NCT03234179
- Acronym / sponsor ID
- 201705110RIND
- Conditions
- Lung Cancer, Genetic Predisposition to Disease
- Keywords
- Non small cell lung cancer, Genetic study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2037 (estimated)
- First posted
- 31 Jul 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.
Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence rates of lung cancer among never smoking females in some parts of East Asia are among the highest in the world. The adenocarcinoma of lung being the most frequently identified histological type is more weakly associated with smoking, and often occurs in females and never-smokers. Although family history of lung cancer has been associated with histological subtypes, the inherited susceptibility factors that affect specific histology are unknown.
Genetic factors that determine individual predisposition to lung cancer have been identified via genome-wide association studies. These known common loci, however, explain only a small fraction of the familial risk of lung cancer. The hypothesis of this study is that there are genetic factors that confer inherited susceptibility among patients with primary non-small-cell lung cancer (NSCLC).
Detailed description
To delineate the genetic etiology underlying NSCLC, this study proposes to employ a family-based linkage analysis, together with rich data generated from NGS, to search for disease susceptibility locus for the patients with strong family history of primary NSCLC. By using family pedigrees, linkage analysis will be able to find co-segregation of alleles through multiple generations at a genetic susceptibility locus and a known genetic marker, and then the highly penetrate gene loci may be detected by our study. These gene loci will be a good genetic predictor of NSCLC which should be a great advantage in treatment, prevention and screening of NSCLC in the future.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of primary non small cell lung cancer
Key inclusion criteria (2 listed)
- The patient's family (within third-degree relatives) has at least one diagnosed of primary non-small cell lung cancer.
- The patient was diagnosed of primary non-small cell lung cancer at the age < 45 years old.
Key exclusion criteria (3 listed)
- Patients without the diagnosis of primary non-small cell lung cancer.
- Patients who are combined with other malignancy and ongoing chemotherapy / radiation therapy.
- Patients combined with coagulopathy.
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
Genetic information of lung cancer patients
Time frame: One week after the study subjects sign the permit of informed consents
Collect study subjects' blood sample and analysis with Genome-wide SNP genotyping
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No. No plan to share IPD to other researchers.
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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.
Jin-Shing Chen, PhD study director
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Genetic Predisposition to Disease, run by National Taiwan University 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 2 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: opening soon, as of the sponsor's last update on 1 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tung-Ming Tsai, MD (+886972792011, eldorado0607@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic information of lung cancer patients (time frame: One week after the study subjects sign the permit of informed consents). 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 Aug 2017.