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A study on genetic polymorphism analysis using buccal mucosal tissue of the registered patients (UMIN000001676)

A study on genetic polymorphism analysis using buccal mucosal tissue of the registered patients (UMIN000001676) - Japan Esophageal Cohort study Genetic polymorphism analysis: JEC-G study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000034761
Enrollment
331
Registered
2018-11-05
Start date
2018-11-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal squamous cell carcinoma

Interventions

None listed

Sponsors

Grant-in-Aid for Scientific Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Newly diagnosed early squamous cell carcinoma of the esophagus. (2) Complete endoscopic resection (ER) as assessed visually on Lugol chromoendoscopy immediately after ER. (3) A diagnosis of squamous cell carcinoma on histopathological examination of the resected specimen. (4) Vertical margins of the resected specimen are confirmed to be tumor-negative. (5) Tumor invasion is limited to the mucosa on histopathological examination of the resected specimen, and no additional treatment (surgical resection, radiotherapy, chemotherapy, etc.) is performed immediately after ER. (6) No active head or neck cancers. (7) The investigator judges that patient can be observed for at least 2 years. (8) Written informed consent is obtained from the patient.

Exclusion criteria

Exclusion criteria: (1) A history of chemotherapy for any other cancers or a history of surgical treatment or radiotherapy for head and neck cancers. (2) A history of iodine allergy. (3) Patients whom the investigator considers unsuitable as subjects for this study.

Design outcomes

Primary

MeasureTime frame
The cumulative incidence of metachronous cancers as assessed by the Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism

Secondary

MeasureTime frame
The total annual number of cases of metachronous cancers as assessed by the Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism

Countries

Japan

Contacts

Public ContactChikatoshi Katada

Kitasato University School of Medicine Department of Gastroenterology

ckatada@med.kitasato-u.ac.jp042-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026