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Serum biomarker study for superficial esophageal cancer

A prospective validation study of the serum biomarker for the stage diagnosis of superficial esophageal cancer - E-bio study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000044601
Enrollment
100
Registered
2021-09-01
Start date
2021-11-01
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

superficial esophageal cancer

Interventions

None listed

Sponsors

Nagoya City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Either "histologically confirmed high grade intraepithelial neoplasia, squamous cell carcinoma, or adenocarcinoma" or "endoscopically diagnosed as esophageal cancer" 2.Clinically diagnosed as T1 stage, superficial esophageal cancer 3.20 years old =< age =< 85 years old 4.PS:0-2 5.Plan of endoscopic or surgical tumor resection 6.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients with other active malignancies 2.Difficulty of tumor resection due to poor physical condition 3.Patients who will be treated by radiation therapy, chemotherapy or argon plasma coagulation therapy. 4.Patients with severe mental disorder and dementia 5.Investigator's decision

Design outcomes

Primary

MeasureTime frame
Accuracy of the serum biomarker for the stage diagnosis (squamous cell carcinoma)

Secondary

MeasureTime frame
1. Accuracy of the serum biomarker for the stage diagnosis (adenocarcinoma) 2. Sensitivity, specificity, PPV and NPV of the serum biomarker for surgical indication 3. Comparison between the serum biomarker and endoscopic diagnosis for the accuracy of the stage diagnosis 4. Accuracy, sensitivity, specificity, PPV and NPV by combining the serum biomarker and endoscopic diagnosis 5. Comparison between the combination biomarker and endoscopy alone for the accuracy of the stage diagnosis 6. Assessment of the tissue biomarkers

Countries

Japan

Contacts

Public ContactYusuke Okuda

Nagoya City University Graduate School of Medical Sciences Department of Gastroenterology and Metabolism

tshimura@med.nagoya-cu.ac.jp052-853-8211

Outcome results

None listed

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