Gastric CancerDESTINEX-REMNCT07243015
Detection of Minimal Residual Disease Using Exosomal miRNA Distant Metastasis Markers
An observational study of Gastric Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
Gastric cancer (GC) is a leading cause of cancer-related death worldwide. Even in patients undergoing curative surgery for non-metastatic disease, postoperative recurrence frequently occurs due to undetected minimal residual disease (MRD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- small RNA-seq or array and ENLIGHT Assay
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 18 Jun 2028
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent curative-intent gastrectomy for gastric adenocarcinoma, with available pre- and postoperative plasma samples.
Who may be able to join
- Histologically confirmed gastric adenocarcinoma.
- Underwent curative-intent resection (R0).
- Availability of pre- and postoperative plasma samples.
- Documented clinical follow-up data (recurrence/metastasis status).
- Provided written informed consent.
Who cannot join
- Insufficient plasma volume or RNA quality for exosomal extraction.
- Presence of synchronous or metachronous malignancies.
- Received neoadjuvant chemotherapy without postoperative follow-up.
- Lack of consent or incomplete clinicopathologic data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91016
Ajay Goel, PhD, 626-218-3452, ajgoel@coh.org
About this study
Official title: Exosomal microRNA-based Analysis for Early detectIon of Gastric Cancer Hidden-recurrence Traces
Gastric cancer (GC) is a leading cause of cancer-related death worldwide. Even in patients undergoing curative surgery for non-metastatic disease, postoperative recurrence frequently occurs due to undetected minimal residual disease (MRD). This study aims to establish a highly sensitive and specific liquid biopsy assay using exosomal microRNAs (exo-miRNAs) to detect MRD and predict distant metastasis before clinical recurrence.
Read the detailed description
Postoperative recurrence in gastric cancer is largely driven by occult micrometastatic disease that remains undetectable by conventional imaging. While circulating tumor DNA (ctDNA) assays have shown utility in MRD detection, their limited sensitivity and tumor-type variability hinder consistent application in gastric cancer.
Exosomal microRNAs (exo-miRNAs), encapsulated within lipid bilayer vesicles, remain stable in circulation and reflect tumor-derived molecular information. This study seeks to develop and validate an exosomal miRNA-based signature capable of detecting minimal residual disease and predicting future distant metastasis after curative gastrectomy.
Study Phases
- Discovery Phase - Comprehensive small RNA sequencing to identify miRNAs specific to distant metastasis in gastric cancer.
- Training Phase - RT-qPCR-based quantification of candidate exo-miRNAs in postoperative plasma samples to develop an MRD signature.
- Validation Phase - Independent cohort testing to evaluate the diagnostic performance, sensitivity, and specificity of the exosomal MRD panel.
Ultimately, the ENLIGHT assay aims to guide postoperative adjuvant chemotherapy by stratifying patients according to MRD status, enabling precision surveillance and early intervention.
- Conditions
- Gastric Cancer
- Being tested
- small RNA-seq or array, ENLIGHT Assay
- Keywords
- GC, MRD, Tumor recurrence, Exosomal microRNAs, Gastric cancer
- Medical subject headings
- Stomach Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
small RNA-seq or arrayDiagnostic test
small RNA-seq or array
ENLIGHT AssayDiagnostic test
RT-qPCR-based exo-miRNA quantification
| Study group | Role | What they receive |
|---|---|---|
| Discovery Cohort - Distant Metastasis Positive | Patients with postoperative distant metastasis; used for biomarker discovery via small RNA sequencing. Receives: Diagnostic Test: small RNA-seq or array | |
| Discovery Cohort - Distant Metastasis Negative | Patients without postoperative metastasis; used as reference controls in discovery phase. Receives: Diagnostic Test: small RNA-seq or array | |
| Training Cohort - MRD Positive (High Risk) | Patients exhibiting postoperative recurrence within 12 months. Receives: Diagnostic Test: ENLIGHT Assay | |
| Training Cohort - MRD Negative (Low Risk) | Patients without recurrence ≥12 months postoperatively. Receives: Diagnostic Test: ENLIGHT Assay | |
| Validation Cohort - MRD Positive | Independent validation cohort with confirmed distant metastasis or MRD positivity. Receives: Diagnostic Test: ENLIGHT Assay | |
| Validation Cohort - MRD Negative | Independent validation cohort without recurrence/metastasis. Receives: Diagnostic Test: ENLIGHT Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
Time from surgery to recurrence or death.
Measured: up to 5 years
Secondary outcomes (1)
Overall Survival (OS)
Time from surgery to death from any cause
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Jan 2025
- Primary completion18 Jun 2028 (estimated)
- Study completion18 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243015
- Sponsor's protocol ID
- 23228/DESTINEX-REMNANT
- Acronym
- DESTINEX-REM
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosomal microRNA-based Analysis for Early detectIon of Gastric Cancer Hidden-recurrence Traces
- ClinicalTrials.gov ID
- NCT07243015
- Acronym / sponsor ID
- DESTINEX-REM / 23228/DESTINEX-REMNANT
- Conditions
- Gastric Cancer
- Keywords
- GC, MRD, Tumor recurrence, Exosomal microRNAs, Gastric cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 18 Jun 2028 (estimated)
- Study completion
- 18 Jun 2028 (estimated)
- First posted
- 21 Nov 2025 (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.
Gastric cancer (GC) is a leading cause of cancer-related death worldwide. Even in patients undergoing curative surgery for non-metastatic disease, postoperative recurrence frequently occurs due to undetected minimal residual disease (MRD). This study aims to establish a highly sensitive and specific liquid biopsy assay using exosomal microRNAs (exo-miRNAs) to detect MRD and predict distant metastasis before clinical recurrence.
Detailed description
Postoperative recurrence in gastric cancer is largely driven by occult micrometastatic disease that remains undetectable by conventional imaging. While circulating tumor DNA (ctDNA) assays have shown utility in MRD detection, their limited sensitivity and tumor-type variability hinder consistent application in gastric cancer.
Exosomal microRNAs (exo-miRNAs), encapsulated within lipid bilayer vesicles, remain stable in circulation and reflect tumor-derived molecular information. This study seeks to develop and validate an exosomal miRNA-based signature capable of detecting minimal residual disease and predicting future distant metastasis after curative gastrectomy.
Study Phases
- Discovery Phase - Comprehensive small RNA sequencing to identify miRNAs specific to distant metastasis in gastric cancer.
- Training Phase - RT-qPCR-based quantification of candidate exo-miRNAs in postoperative plasma samples to develop an MRD signature.
- Validation Phase - Independent cohort testing to evaluate the diagnostic performance, sensitivity, and specificity of the exosomal MRD panel.
Ultimately, the ENLIGHT assay aims to guide postoperative adjuvant chemotherapy by stratifying patients according to MRD status, enabling precision surveillance and early intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Discovery Cohort - Distant Metastasis Positive | – | Diagnostic Test: small RNA-seq or arrayPatients with postoperative distant metastasis; used for biomarker discovery via small RNA sequencing. |
| Discovery Cohort - Distant Metastasis Negative | – | Diagnostic Test: small RNA-seq or arrayPatients without postoperative metastasis; used as reference controls in discovery phase. |
| Training Cohort - MRD Positive (High Risk) | – | Diagnostic Test: ENLIGHT AssayPatients exhibiting postoperative recurrence within 12 months. |
| Training Cohort - MRD Negative (Low Risk) | – | Diagnostic Test: ENLIGHT AssayPatients without recurrence ≥12 months postoperatively. |
| Validation Cohort - MRD Positive | – | Diagnostic Test: ENLIGHT AssayIndependent validation cohort with confirmed distant metastasis or MRD positivity. |
| Validation Cohort - MRD Negative | – | Diagnostic Test: ENLIGHT AssayIndependent validation cohort without recurrence/metastasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent curative-intent gastrectomy for gastric adenocarcinoma, with available pre- and postoperative plasma samples.
Key inclusion criteria (5 listed)
- Histologically confirmed gastric adenocarcinoma.
- Underwent curative-intent resection (R0).
- Availability of pre- and postoperative plasma samples.
- Documented clinical follow-up data (recurrence/metastasis status).
- Provided written informed consent.
Key exclusion criteria (4 listed)
- Insufficient plasma volume or RNA quality for exosomal extraction.
- Presence of synchronous or metachronous malignancies.
- Received neoadjuvant chemotherapy without postoperative follow-up.
- Lack of consent or incomplete clinicopathologic data.
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 |
|---|---|---|
| small RNA-seq or arraysmall RNA-seq or array | Diagnostic test | Discovery Cohort - Distant Metastasis Negative, Discovery Cohort - Distant Metastasis Positive |
| ENLIGHT AssayRT-qPCR-based exo-miRNA quantification | Diagnostic test | Training Cohort - MRD Negative (Low Risk), Training Cohort - MRD Positive (High Risk), Validation Cohort - MRD Negative, Validation Cohort - MRD Positive |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: up to 5 years
Time from surgery to recurrence or death.
1 secondary outcome
Overall Survival (OS)
Time frame: up to 5 years
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 6 Jul 2026.
- Individual participant dataSharing planned: No. Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
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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?
An observational study of Gastric Cancer, run by City of Hope Medical Center at 1 site in United States.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Jul 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 United States. 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 Ajay Goel, PhD (626-218-3452, ajgoel@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: up to 5 years). 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 6 Jul 2026.