HER2 Testing in gastric cancer by LCI/BLI guided gastroscopic biopsy versus normal biopsy: a Double-blind Randomized Controlled Prospective Clinical Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025093

Enrollment

Unknown

Registered

2019-08-10

Start date

2019-10-01

Completion date

Unknown

Last updated

2019-09-30

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

Conditions

Gastric cancer

Interventions

LCI/BLI group:LCI and BLI observe

control group:WLI observe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Understand and comply with the protocol of trial; (2) With Signature on informed consent form; (3) Chinese, aged over 18 years; (4) Suspect of gastric cancer which need confirmed by gastroscopy and biopsy.

Exclusion criteria

Exclusion criteria: (1) Cannot tolerate with gastroscopy; (2) With severe cardiopulmonary disease; (3) With coagulation disorders; (4) Pregnancy or lactation; (5) With confirmed cancer in other site.

Design outcomes

Primary

Measure	Time frame
positive rate of HER2;Blocks of biopsy needed for HER2 testing;	—

Secondary

Measure	Time frame
Positive rate for the 1st block;Cumulative positive rate after the 2nd block;Cumulative positive rate after the 3rd block;Cumulative positive rate after the 4th block;Cumulative positive rate after the 5th block;Cumulative positive rate after the 2nd block;	—

Countries

China

Contacts

Public ContactWeiguang Qiao

Nanfang Hospital, Southern Medical University

qwg1991@126.com+86 13129373055

Outcome results

None listed

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