Clinical trial · Observational
Potential Clinical Utilities of Circulating Tumor DNA in Advanced HER2 Negative Gastric Cancer
Monitoring Circulating Tumor DNA and Evaluating Prognostic and Predictive Impact of Liquid Biopsy in Advanced HER2 Negative Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the use of next generation sequencing (NGS) to detect circulating tumor DNA in advanced HER2 negative gastric cancer patients. The evaluation of the therapy efficacy for gastric cancer patients is usually evaluated by computer tomography scans with RECIST criteria that are performed every two months during the treatment. In this study, we will compare the monitoring of circulating tumor DNA with the results of CT scan according the RECIST criteria and the blood level of CEA and CA 19-9 tumor markers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor DNA (ctDNA) | Gastric Neoplasm | PROBABILISTIC | 0.70 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Prognostic molecular markers.
- timeFrame
- 2 years
- description
- Change from baseline in molecular biomarkers at time on disease progression
- measure
- The sensitivity and specificity of ctDNA detection. Profiling of the most frequently detected gene mutations and level of mutations in ctDNA
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- Mutation profile and the concordance of mutations in tumor tissue and ctDNA of gastric cancer
- timeFrame
- 2 years
- measure
- Mechanisms of therapy resistance
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients age 18 - 75. 2. Histologically confirmed adenocarcinoma of gastric or gastro-oesophageal junction. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy. 3. HER2 status is confirmed by IHC/FISH. HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative. 4. At least one measurable lesion should be confirmed by imaging examination. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6. No concomitant other malignant tumor or treated malignant tumor within last five years. 7. Eligible peripheral blood and tissue samples. 8. Willing to provide clinicopathological information and imaging information. Exclusion Criteria: 1. Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months. 2. With second primary malignant diseases. 3. HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive. 4. No qualified paired tissue samples. 5. No complete clinicopathological information and follow-up. 6. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent. 7. Other situations assessed by investigator can disturb quality control of the investigation.
References
Publications (0)
Data not yet available