Condition/DiseaseALDHNCT07273279
ADH1B and ALDH Gene Variants and Lung Cancer Risk
An observational study of Condition/Disease and Lung Cancer (Diagnosis), run by Kaohsiung Medical University.
Trial summary
Lung cancer in never-smokers is increasingly recognized as a disease influenced by genetic susceptibility. Aldehyde-metabolizing enzymes, including the ALDH gene family and ADH1B, play key roles in detoxifying reactive aldehydes that can damage DNA and promote oxidative stress. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Condition/Disease, Lung Cancer (Diagnosis), Lung Adenocarcinoma
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2027
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lung cancer status determined by pathology-confirmed diagnosis at the time of case identification
Who may be able to join
- Incident lung cancer cases confirmed by pathology and healthy adult over age of 18 years.
Who cannot join
- Individuals with incomplete data will not be included as study participants.
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
Official title: Associations of ADH1B and ALDH Family Gene Polymorphisms With Lung Cancer Risk and Its Subtypes: Results From the Oncoarray Project of the International Lung Cancer Consortium
Lung cancer in never-smokers is increasingly recognized as a disease influenced by genetic susceptibility. Aldehyde-metabolizing enzymes, including the ALDH gene family and ADH1B, play key roles in detoxifying reactive aldehydes that can damage DNA and promote oxidative stress. In this study, we will examine whether ten selected genetic variants, nine single nucleotide polymorphisms (SNPs) across five ALDH family genes and one variant in ADH1B are associated with the risk of lung cancer and its major subtypes. Limited epidemiological evidence is currently available on the association between these aldehyde-metabolizing gene variants and lung cancer. This research aims to clarify their potential contribution to the development of lung cancer, particularly among never-smokers.
Read the detailed description
This case-control study aims to investigate the association of ten genetic variants-nine SNPs across five ALDH family genes and one SNP in ADH1B (rs1229984)-with the risk of lung cancer and its major subtypes. The primary hypothesis is that the ALDH2 rs671 variant is associated with the risk of lung cancer and its major subtypes. The secondary hypothesis is that other ALDH variants-including rs2228093 and rs2073478 in ALDH1B1, rs1127717 and rs2276724 in ALDH1L1, rs3741172, rs17856219, and rs77341916 in ALDH3B2, and rs3765310 in ALDH5A1-are also associated with lung cancer risk. Demographic and lifestyle covariates such as age, gender, ethnicity, smoking status, alcohol consumption, educational level, and case-control status will be incorporated into the analysis.
- Keywords
- ALDH2, ADH1B, Lung cancer
- Medical subject headings
- Disease, Lung Neoplasms, Adenocarcinoma of Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer status (case vs control)
Lung cancer status determined by pathology-confirmed diagnosis at the time of case identification
Measured: Not applicable (baseline status)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condition/DiseaseStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzu Yu Pan, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273279
- Sponsor's protocol ID
- KMUHIRB-E(I)-20250145
- Other IDs
- 113-2314-B-037 -070 -MY3
- Acronym
- ALDH
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because data use agreements restrict redistribution of participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of ADH1B and ALDH Family Gene Polymorphisms With Lung Cancer Risk and Its Subtypes: Results From the Oncoarray Project of the International Lung Cancer Consortium
- ClinicalTrials.gov ID
- NCT07273279
- Acronym / sponsor ID
- ALDH / KMUHIRB-E(I)-20250145
- Keywords
- ALDH2, ADH1B, Lung cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Dec 2025 (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 in never-smokers is increasingly recognized as a disease influenced by genetic susceptibility. Aldehyde-metabolizing enzymes, including the ALDH gene family and ADH1B, play key roles in detoxifying reactive aldehydes that can damage DNA and promote oxidative stress. In this study, we will examine whether ten selected genetic variants, nine single nucleotide polymorphisms (SNPs) across five ALDH family genes and one variant in ADH1B are associated with the risk of lung cancer and its major subtypes. Limited epidemiological evidence is currently available on the association between these aldehyde-metabolizing gene variants and lung cancer. This research aims to clarify their potential contribution to the development of lung cancer, particularly among never-smokers.
Detailed description
This case-control study aims to investigate the association of ten genetic variants-nine SNPs across five ALDH family genes and one SNP in ADH1B (rs1229984)-with the risk of lung cancer and its major subtypes. The primary hypothesis is that the ALDH2 rs671 variant is associated with the risk of lung cancer and its major subtypes. The secondary hypothesis is that other ALDH variants-including rs2228093 and rs2073478 in ALDH1B1, rs1127717 and rs2276724 in ALDH1L1, rs3741172, rs17856219, and rs77341916 in ALDH3B2, and rs3765310 in ALDH5A1-are also associated with lung cancer risk. Demographic and lifestyle covariates such as age, gender, ethnicity, smoking status, alcohol consumption, educational level, and case-control status will be incorporated into the analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer status determined by pathology-confirmed diagnosis at the time of case identification
Key inclusion criteria (1 listed)
- Incident lung cancer cases confirmed by pathology and healthy adult over age of 18 years.
Key exclusion criteria (1 listed)
- Individuals with incomplete data will not be included as study participants.
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
Lung cancer status (case vs control)
Time frame: Not applicable (baseline status)
Lung cancer status determined by pathology-confirmed diagnosis at the time of case identification
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 9 Dec 2025.
- Individual participant dataSharing planned: No. IPD will not be shared because data use agreements restrict redistribution of participant-level data.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Condition/Disease and Lung Cancer (Diagnosis), run by Kaohsiung Medical University.
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: opening soon, as of the sponsor's last update on 9 Dec 2025. 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 Tzu Yu Pan, PhD (886-3221806, R990174@gap.kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer status (case vs control) (time frame: Not applicable (baseline status)). 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 9 Dec 2025.