Gastro Oesophageal CancerGASTROTRACKNCT07884669
Biomarker Investigation for Early Gastric Cancer Detection
A study testing Saliva sampling, Gastric juice sampling and Blood sampling in people with Gastro Oesophageal Cancer, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastro Oesophageal Cancer
- What is being tested?
- Saliva sampling, Gastric juice sampling and Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Léon Bérard
Lyon
Clélia COUTZAC, +33 (0)4 78 78 59 92, clelia.coutzac@lyon.unicancer.fr
About this study
Official title: Biomarker Investigation for Early Gastric Cancer Detection: a Prospective Study in Gastric and Gastroesophageal Junction Adenocarcinomas (G/GEJ)
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.
Read the detailed description
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.
- Conditions
- Gastro Oesophageal Cancer
- Being tested
- Saliva sampling, Gastric juice sampling, Blood sampling, Tumor sampling
- Keywords
- gastric cancer, non-invasive biomarkers, multi-omics
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva samplingProcedure or surgery
Saliva will be collected during gastroscopy visit, before the intervention takes place.
Gastric juice samplingProcedure or surgery
Gastric juice will be collected during gastroscopy, at the beginning of the intervention.
Blood samplingProcedure or surgery
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 samplingProcedure or surgery
Tumor samples collected if medically indicated during gastroscopy and at disease progression as part of standard of care will be used.
| Study group | Role | What they receive |
|---|---|---|
| Non-operable gastroesophageal cancer | Experimental | Not described Receives: Procedure: Saliva sampling; Procedure: Gastric juice sampling; Procedure: Blood sampling; Procedure: Tumor sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At gastroscopy
Secondary outcomes (13)
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.
Measured: Baseline (C1D1 pre-dose)
Longitudinal variation of ctDNA.
Changes in ctDNA levels measured in serial plasma samples collected during follow-up.
Measured: 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.
Measured: Up to 24 months after last patient enrolled
Association between ctDNA status and overall survival.
Overall survival according to detectable versus non-detectable ctDNA.
Measured: 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.
Measured: Baseline (C1D1 pre-dose)
Association between cytokine concentrations and progression occurrence.
Measured: Up to 24 months after last patient enrolled
Progression-free survival according to cytokine concentrations.
Measured: Up to 24 months after last patient enrolled
Overall survival according to cytokine concentrations.
Measured: 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.
Measured: 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.
Measured: At gastroscopy and at disease progression (if available)
Association between microenvironment features and disease progression occurrence.
Measured: Up to 24 months after last patient enrolled
Overall survival associated with tumor microenvironment features.
Measured: 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 .
Measured: Up to 24 months after last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Additionnal biological sample collection
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884669
- Sponsor's protocol ID
- ET26-125
- Other IDs
- 2026-A01605-46
- Acronym
- GASTROTRACK
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Investigation for Early Gastric Cancer Detection: a Prospective Study in Gastric and Gastroesophageal Junction Adenocarcinomas (G/GEJ)
- ClinicalTrials.gov ID
- NCT07884669
- Acronym / sponsor ID
- GASTROTRACK / ET26-125
- Conditions
- Gastro Oesophageal Cancer
- Keywords
- gastric cancer, non-invasive biomarkers, multi-omics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Additionnal biological sample collection
| Arm | Type | Receives |
|---|---|---|
| Non-operable gastroesophageal cancer | Experimental | Procedure: Saliva sampling, Procedure: Gastric juice sampling, Procedure: Blood sampling, Procedure: Tumor sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva samplingSaliva will be collected during gastroscopy visit, before the intervention takes place. | Procedure or surgery | Non-operable gastroesophageal cancer |
| Gastric juice samplingGastric juice will be collected during gastroscopy, at the beginning of the intervention. | Procedure or surgery | Non-operable gastroesophageal cancer |
| Blood samplingBlood 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. | Procedure or surgery | Non-operable gastroesophageal cancer |
| Tumor samplingTumor samples collected if medically indicated during gastroscopy and at disease progression as part of standard of care will be used. | Procedure or surgery | Non-operable gastroesophageal cancer |
Primary outcome
Diagnostic performance of salivary and gastric juice biomarker signatures for identifying gastric and gastroesophageal junction cancer (GEC).
Time frame: 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.
13 secondary outcomes
Presence of circulating tumor DNA (ctDNA) at baseline.
Time frame: Baseline (C1D1 pre-dose)
Longitudinal variation of ctDNA.
Time frame: From baseline through disease progression (up to 24 months after last patient enrolled)
Association between ctDNA status and progression-free survival.
Time frame: Up to 24 months after last patient enrolled
Association between ctDNA status and overall survival.
Time frame: Up to 24 months after last patient enrolled
Plasma cytokine concentrations at baseline.
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.
Time frame: At gastroscopy and at disease progression (if available)
Tumor microenvironment characteristics measured by multiplex immunofluorescence (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.
Time frame: Up to 24 months after last patient enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva sampling, Gastric juice sampling and Blood sampling in people with Gastro Oesophageal Cancer, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clélia COUTZAC (+33 (0)4 78 78 59 92, clelia.coutzac@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of salivary and gastric juice biomarker signatures for identifying gastric and gastroesophageal junction cancer (GEC). (time frame: At gastroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.