A Multicentre Observational Cross-Sectional Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorAsian Institute of Gastroenterology, India

About this trial

To estimate the prevalence of histologically confirmed early gastric cancer (EGC) in an Indian multicentre cohort undergoing standardised high-quality upper gastrointestinal endoscopy. EGC is defined as gastric adenocarcinoma confined to the mucosa or submucosa (T1), irrespective of lymph node status, based on histopathology.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged ≥40 years undergoing upper gastrointestinal endoscopy for dyspepsia or other clinical indications (nonalarming and alarming symptoms both).

Ability to provide written informed consent.

Disqualifiers

Known gastric malignancy.

Prior gastric surgery (excluding H. pylori eradication).

Contraindications to endoscopy or biopsy.

Known hereditary gastric cancer syndromes.

Trial population

4,000

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Prevalence of histologically confirmed early gastric cancer

Prevalence (proportion) of histologically confirmed early gastric cancer (EGC) detected on biopsy or endoscopic resection specimen during the endoscopy.

Time frame
2 years

Secondary outcomes

1

Prevalence of gastric precancerous lesions

Prevalence and distribution of gastric precancerous lesions, including: Atrophic gastritis, Intestinal metaplasia (EGGIM positive: Yes/No; and histologic IM/OLGIM), Low-grade dysplasia (LGD), High-grade dysplasia (HGD), Advanced precancerous phenotype (OLGIM III-IV and/or HGD)

Time frame
2 years
2

Clinical and demographic predictors

Predictors of precancerous lesions

Time frame
2 years
3

Endoscopy-pathology concordance

Endoscopy-pathology concordance, including concordance between: Endoscopic suspicion and histology

Time frame
2 years

Other outcomes

Sponsors and contacts

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