Esophageal CancerNCT07322627
ALDH2 Single Nucleotide Polymorphisms and Prognosis of Esophageal Cancer Patients
An observational study of Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Alcohol consumption, smoking, and betel nut chewing have been proven to be closely associated with the risk of esophageal cancer (EC). Recent studies have shown that alcohol-related detoxification genes in the ALDH family influence individual susceptibility to esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Esophageal Cancer
- How many people
- 700 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Dec 2025to 31 Oct 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Totally up to 778 subjects with esophageal cancer will be retrospectively enrolled in National Taiwan University Hospital (NTUH) during the periods of study (from Dec 15, 2011 to Dec 31, 2024) with approval from the ethical committee of NTUH (202511005RINA).
Who may be able to join
- Patients who have been pathologically confirmed to have esophageal cancer and who have previously signed consent forms indicating their willingness to provide remaining samples for subsequent studies.
Who cannot join
- Female patients or patients younger than 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Jang-Ming Lee, +886 223123456, jmlee@ntu.edu.tw
About this study
Alcohol consumption, smoking, and betel nut chewing have been proven to be closely associated with the risk of esophageal cancer (EC). Recent studies have shown that alcohol-related detoxification genes in the ALDH family influence individual susceptibility to esophageal cancer. Aldehyde dehydrogenase 2 (ALDH2) is one of the most important enzymes in the ALDH family, involved in the metabolism of alcohol, acetaldehyde, and environmental aldehydes in the human body. We hypothesize that functional variations in ALDH2 may have a significant impact on the survival of esophageal cancer patients. This study aims to investigate the correlation between ALDH2 gene polymorphism and the survival of esophageal cancer patients.
Read the detailed description
Many single nucleotide polymorphisms in genes involved in cell cycle progression, DNA repair, metabolism, and immune response have been implicated in susceptibility to cancers via different mechanisms, and thus might be used as diagnostic or prognostic markers of cancers. The most widely studied SNP for ALDH2 is rs671. Single nucleotide polymorphism of rs671 has two subtypes indicated as ALDH2*1 (G) and ALDH2*2 (A). The aldehyde dehydrogenase generated by ALDH2*2 (A) allele has a missense amino acid substitution (Glu504Lys in full length of cytoplasmic protein or Glu487Lys in mature mitochondrial protein) which causes low activity of ALDH2 in catalyzing the oxidation of toxic acetaldehyde into non-toxic acetic acid, leading to accumulation of acetaldehyde and increased incidence of cancers.
Around 40% of population in China carried the ALDH2*2 (A) allele; therefore, Chinese alcohol consumers with dysfunctional allele were more susceptible to upper aerodigestive tract cancers. A synergistic interaction between rs671 and alcohol consumption was also reported to increase the risk of head and neck cancer (HNC) and esophageal cancer by different research groups. Yokoyama et al. first found that Japanese male drinkers with inactivated ALDH2 were susceptible to multiple primary cancers with EC or oropharyngolaryngeal squamous cell carcinoma. Our previous study also demonstrated that ALDH2 rs671 was significantly associated with multiple primary cancers involving EC and head and neck cancer (HNC). However, ALDH2*2 (A) has also been reported to be a protective factor of colorectal cancer in a meta-analysis, and be indirectly associated with low risk of colorectal cancer, hepatocellular carcinoma, as well as digestive tract cancers among moderate alcohol consumers. Those with the ALDH2*2 variant often consumed less alcohol due to the acetaldehyde-induced unpleasant effects, which may decrease their risk for alcohol induced disorders. In addition, ALDH2*2 (A) was also reported to confer protective effect on ovarian cancer which was not related to alcohol consumption. To date, there were limited studies investigating the prognostic impact of ALDH2 SNPs on EC. In this study we aim to clarify the prognostic meanings of ALDH2 SNPs on EC.
- Conditions
- Esophageal Cancer
- Keywords
- ALDH2, prognosis
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
death
We will trace the patients with esophageal cancer for up to 150 months since the date of first diagnosis or undergoing esophagectomy, regarding their survival status. We will calculate the overall survival time (months) of each subject, and draw the overall survival curves for all patients based on their genotypes of SNP at ALDH2 locus.
Measured: from the date of first diagnosis or undergoing esophagectomy to the end of 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start8 Dec 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322627
- Sponsor's protocol ID
- 202511005RINA
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALDH2 Single Nucleotide Polymorphisms and Prognosis of Esophageal Cancer Patients
- ClinicalTrials.gov ID
- NCT07322627
- Acronym / sponsor ID
- 202511005RINA
- Conditions
- Esophageal Cancer
- Keywords
- ALDH2, prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Jan 2026 (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.
Alcohol consumption, smoking, and betel nut chewing have been proven to be closely associated with the risk of esophageal cancer (EC). Recent studies have shown that alcohol-related detoxification genes in the ALDH family influence individual susceptibility to esophageal cancer. Aldehyde dehydrogenase 2 (ALDH2) is one of the most important enzymes in the ALDH family, involved in the metabolism of alcohol, acetaldehyde, and environmental aldehydes in the human body. We hypothesize that functional variations in ALDH2 may have a significant impact on the survival of esophageal cancer patients. This study aims to investigate the correlation between ALDH2 gene polymorphism and the survival of esophageal cancer patients.
Detailed description
Many single nucleotide polymorphisms in genes involved in cell cycle progression, DNA repair, metabolism, and immune response have been implicated in susceptibility to cancers via different mechanisms, and thus might be used as diagnostic or prognostic markers of cancers. The most widely studied SNP for ALDH2 is rs671. Single nucleotide polymorphism of rs671 has two subtypes indicated as ALDH2*1 (G) and ALDH2*2 (A). The aldehyde dehydrogenase generated by ALDH2*2 (A) allele has a missense amino acid substitution (Glu504Lys in full length of cytoplasmic protein or Glu487Lys in mature mitochondrial protein) which causes low activity of ALDH2 in catalyzing the oxidation of toxic acetaldehyde into non-toxic acetic acid, leading to accumulation of acetaldehyde and increased incidence of cancers.
Around 40% of population in China carried the ALDH2*2 (A) allele; therefore, Chinese alcohol consumers with dysfunctional allele were more susceptible to upper aerodigestive tract cancers. A synergistic interaction between rs671 and alcohol consumption was also reported to increase the risk of head and neck cancer (HNC) and esophageal cancer by different research groups. Yokoyama et al. first found that Japanese male drinkers with inactivated ALDH2 were susceptible to multiple primary cancers with EC or oropharyngolaryngeal squamous cell carcinoma. Our previous study also demonstrated that ALDH2 rs671 was significantly associated with multiple primary cancers involving EC and head and neck cancer (HNC). However, ALDH2*2 (A) has also been reported to be a protective factor of colorectal cancer in a meta-analysis, and be indirectly associated with low risk of colorectal cancer, hepatocellular carcinoma, as well as digestive tract cancers among moderate alcohol consumers. Those with the ALDH2*2 variant often consumed less alcohol due to the acetaldehyde-induced unpleasant effects, which may decrease their risk for alcohol induced disorders. In addition, ALDH2*2 (A) was also reported to confer protective effect on ovarian cancer which was not related to alcohol consumption. To date, there were limited studies investigating the prognostic impact of ALDH2 SNPs on EC. In this study we aim to clarify the prognostic meanings of ALDH2 SNPs on EC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Totally up to 778 subjects with esophageal cancer will be retrospectively enrolled in National Taiwan University Hospital (NTUH) during the periods of study (from Dec 15, 2011 to Dec 31, 2024) with approval from the ethical committee of NTUH (202511005RINA).
Key inclusion criteria (1 listed)
- Patients who have been pathologically confirmed to have esophageal cancer and who have previously signed consent forms indicating their willingness to provide remaining samples for subsequent studies.
Key exclusion criteria (1 listed)
- Female patients or patients younger than 18 years old
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
death
Time frame: from the date of first diagnosis or undergoing esophagectomy to the end of 2024
We will trace the patients with esophageal cancer for up to 150 months since the date of first diagnosis or undergoing esophagectomy, regarding their survival status. We will calculate the overall survival time (months) of each subject, and draw the overall survival curves for all patients based on their genotypes of SNP at ALDH2 locus.
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 7 Jan 2026.
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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.
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 Esophageal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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 Taiwan. 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?
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 Jang-Ming Lee (+886223123456, jmlee@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: from the date of first diagnosis or undergoing esophagectomy to the end of 2024). 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 7 Jan 2026.