NCT07322627

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Dec 2025Oct 2027

Study Start

First participant enrolled

December 8, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 22, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

ALDH2prognosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    from the date of first diagnosis or undergoing esophagectomy to the end of 2024

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • Female patients or patients younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

This study will use the remaining buffy coat frozen at -80°C, separated from whole blood, drawn from the subjects before cancer treatment.

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

Jang-Ming Lee

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

January 7, 2026

Record last verified: 2025-12

Locations