An interventional study of Saliva sampling and Gastric juice sampling in Gastro Oesophageal Cancer, sponsored by Centre Leon Berard. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Diagnostic
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.
GASTROTRACK is a prospective, single-center clinico-biological cohort study conducted at Centre Léon Bérard (Lyon, France).
Participants undergoing upper gastrointestinal endoscopy will provide saliva and gastric juice samples. Tissue biopsies obtained during routine clinical care will undergo standard histopathological examination to establish the final diagnosis and classify participants as cancer or non-cancer. Patients diagnosed with advanced or metastatic non-operable GEC will continue longitudinal follow-up within the study.
For these patients, blood samples will be collected at predefined time points during standard clinical care. Tumor tissue collected during diagnostic procedures will also be analyzed. Saliva and gastric juice samples will be studied for miRNA expression and microbiome composition while plasma and tumor samples will be analyzed for ctDNA, circulating biomarkers, transcriptomic features and tumor microenvironment characteristics.
Through this multidisciplinary and translational approach, GASTROTRACK aims to support the development of risk-adapted diagnostic and surveillance strategies for gastric and gastroesophageal junction cancers.
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Centre Leon Berard is the lead sponsor of 210 studies on the registry; 62 are open to participants now.
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Procedure: Saliva sampling · Procedure: Gastric juice sampling · Procedure: Blood sampling · Procedure: Tumor sampling
Saliva will be collected during gastroscopy visit, before the intervention takes place.
Gastric juice will be collected during gastroscopy, at the beginning of the intervention.
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 samples collected if medically indicated during gastroscopy and at disease progression as part of standard of care will be used.
Diagnostic performance of salivary and gastric juice biomarker signatures for identifying gastric and gastroesophageal junction cancer (GEC).
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.
Time frame: At gastroscopy
Presence of circulating tumor DNA (ctDNA) at baseline.
Detection of ctDNA in plasma collected at treatment initiation in patients with non operable GEC. Percentage of participants with detectable ctDNA.
Time frame: Baseline (C1D1 pre-dose)
Longitudinal variation of ctDNA.
Changes in ctDNA levels measured in serial plasma samples collected during follow-up.
Time frame: From baseline through disease progression (up to 24 months after last patient enrolled)
Association between ctDNA status and progression-free survival.
Progression-free survival according to detectable versus non-detectable ctDNA.
Time frame: Up to 24 months after last patient enrolled
Association between ctDNA status and overall survival.
Overall survival according to detectable versus non-detectable ctDNA.
Time frame: Up to 24 months after last patient enrolled
Plasma cytokine concentrations at baseline.
Plasma concentrations of cytokines measured using multiplex cytokine assays in patients with non operable GEC.
Time frame: Baseline (C1D1 pre-dose)
Association between cytokine concentrations and progression occurrence.
Time frame: Up to 24 months after last patient enrolled
Progression-free survival according to cytokine concentrations.
Time frame: Up to 24 months after last patient enrolled
Overall survival according to cytokine concentrations.
Time frame: Up to 24 months after last patient enrolled
Tumor transcriptomic profiles measured by RNA sequencing.
Transcriptomic signatures identified using RNA sequencing on tumor samples collected at diagnosis and, if available, at disease progression.
Time frame: At gastroscopy and at disease progression (if available)
Tumor microenvironment characteristics measured by multiplex immunofluorescence (multi IF).
Characterization of immune and stromal cell populations in tumor samples using multi IF.
Time frame: At gastroscopy and at disease progression (if available)
Association between microenvironment features and disease progression occurrence.
Time frame: Up to 24 months after last patient enrolled
Overall survival associated with tumor microenvironment features.
Time frame: Up to 24 months after last patient enrolled
Performance of an integrated multi-parametric biomarker model for prediction of survival outcomes.
Integration of microbiome and miRNA signatures on saliva and gastric juice, ctDNA, plasma cytokine, tumor micro-environment features for the prediction of survival outcomes in patients with GEC .
Time frame: Up to 24 months after last patient enrolled
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 309 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 66. This study's planned 24 months is below that.
Counting every sponsor, half of 318 studies reached it within 37 months; a quarter within 19 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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