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Clinical Trials in France / NCT07884669
Starting soon Not applicable

Biomarker Investigation for Early Gastric Cancer Detection

NCT07884669 · tracked via the Priya Life Science France tracker
Sponsor
Centre Leon Berard
Phase
Not applicable
Started
2026-11
Last updated
2026-10-20

Condition(s) studied

Gastro Oesophageal Cancer

Investigational drug(s) / intervention(s)

Saliva samplingGastric juice samplingBlood samplingTumor sampling

Saliva sampling: Saliva will be collected during gastroscopy visit, before the intervention takes place.

Gastric juice sampling: Gastric juice will be collected during gastroscopy, at the beginning of the intervention.

Blood sampling: Blood samples will be collected at 3 timepoints during visits scheduled as part of standard of care: at C1D1 pre-dose (1st line treamtent after diagnosis), at C5D1 pre-dose (1st line treatment) and in case of disease progression during or after 1st line treatment.

Tumor sampling: Tumor samples collected if medically indicated during gastroscopy and at disease progression as part of standard of care will be used.

Study summary

GASTROTRACK is a prospective, single-center clinico-biological cohort study evaluating non-invasive biomarkers for gastric and gastroesophageal junction adenocarcinomas (GEC). Saliva, gastric juice, plasma, and tumor tissue samples will be collected from patients undergoing upper gastrointestinal endoscopy. The study aims to identify molecular and microbial biomarkers associated with cancer diagnosis. Disease monitoring and relapse risk will be evaluated through integration of blood- and tissue-based analyses.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * I1. Patients ≥ 18 years at the day of signing informed consent. * I2. Patients referred for upper gastrointestinal endoscopy due to upper GI symptoms such as dysphagia, unexplained anemia, persistent dyspepsia or melena or following initial GEC diagnosis in another institution. * I3. Patients who have understood, dated, and signed the written voluntary informed consent form. * I4. Patients affiliated with or benefiting from medical insurance. Exclusion Criteria: * E1. Patients with known active malignancy. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer. * E2. Patients with known genetic predisposition such as Lynch syndrome or hereditary diffuse gastric cancer. * E3. Any condition contraindicating any procedure required by the protocol. * E4. Patients presenting a psychological, familial, geographical, or social situation that, in the investigator's judgment, could potentially prevent the signing of informed consent and/or compliance with study procedures. * E5. Pregnant or breast-feeding women.

Primary outcome measure(s)

  • Diagnostic performance of salivary and gastric juice biomarker signatures for identifying gastric and gastroesophageal junction cancer (GEC). — At gastroscopy
    Presence or absence of gastric or gastroesophageal junction cancer confirmed by histopathological examination following gastroscopy. Biomarker signatures derived from salivary and gastric juice miRNA expression profiles and microbiome composition will be evaluated through positive predictive value to discriminate patients with GEC from patients without GEC.

Trial sites (1)

FacilityCityRegionStatus
Centre Léon Bérard Lyon France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07884669 on ClinicalTrials.gov ↗ ← All trials in France