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A prospective study on consistency assessment of claudin18.2 protein expression with different clones in gastrointestinal tumors, automatic and intelligent quantitative assessment and artificial intelligence prediction of claudin18.2 expression status

A prospective study on consistency assessment of claudin18.2 protein expression with different clones in gastrointestinal tumors, automatic and intelligent quantitative assessment and artificial intelligence prediction of claudin18.2 expression status

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077832
Enrollment
Unknown
Registered
2023-11-21
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Tumors of the digestive system

Interventions

Gold Standard:Multiple pathologists comprehensively evaluated the expression fraction of Claudin18.2 protein by immunohistochemistry
Index test:Artificial intelligence algorithms calculate the Claudin 18.2 antibody evaluation score, and calculate the artificial intelligence model to predict the expression status of Claudin 18.2 in

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: This is a prospective clinical study and we will enroll all cases that meet the inclusion criteria from December 2023 to December 2026. Inclusion Criteria: (1) Patients with primary digestive system tumors (including gastric cancer, gastroesophageal junction cancer and esophageal cancer, etc.); (2) Age= 18 years old and = 75 years old; (3) The included gross pathological specimens were not treated before surgery: including radiotherapy, chemotherapy, immunotherapy, etc.; (4) H&E pathological sections and claudin18.2 immunohistochemical slides were derived from the gross pathological samples based on surgical resection.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: (1) Pathological sections can be seen with large wrinkles and film drops; (2) The pathological section scan is not clear and does not focus accurately; (3) The patient's clinical pathological data is not perfect.

Design outcomes

Primary

MeasureTime frame
AUC;Sensitivity;Specificity;kappa;

Countries

China

Contacts

Public ContactMuyan Cai

Sun Yat-sen University Cancer Center

caimy@sysucc.org.cn+86 20 8734 2775

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026