Clinical trial · Observational
Potential Clinical Utilities of Circulating Tumor DNA in Gastric Cancer
Evaluating Potential Clinical Utilities of Circulating Tumor DNA in 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 is designed to evaluate the potential clinical utility of ctDNA in the field of gastric cancer treatment,especially the usage of an indicator of MRD(minimal residual disease) in post radical gastrectomy patients. The primary purpose of this trial is to demonstrate if the postoperative ctDNA analysis could be used as an indicator of MRD or adjuvant chemotherapy response in advanced gastric cancer after radical gastrectomy.The second purpose is to describe the profile of ctDNA in gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVENIO ctDNA surveillance kit | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ctDNA detection
- description
- The blood samples for ctDNA and other tumor markers (such as CEA, et al.) will be first collected within 7 days before surgery, and then be tested after radical gastrectomy in scheduled interval.
- interventionNames
- Combination Product: AVENIO ctDNA surveillance kit
Primary outcomes (2)
- measure
- Description of disease recurrence risk according to first positive ctDNA detection
- timeFrame
- 2 years
- description
- Time is measured from first positive ctDNA detection to disease-free survival event.
- measure
- Description of ctDNA changing to adjuvant chemotherapy response
- timeFrame
- 2 years
- description
- For subjects with postoperative positive ctDNA, time is measured from first adjuvant chemotherapy to first negative ctDNA detection.
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. Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2. 3. Histologically proven primary stomach adenocarcinoma with Lauren type by gastroscopic biopsy before operation. 4. Clinical stage is cT3/4N+M0 and the tumor is resectable in initial evaluation. 5. No preoperative tumor therapy, including chemotherapy, radiotherapy, et al. 6. No concomitant other malignant tumor or treated malignant tumor within last five years. 7. Signed informed consent. 8. Consent to provide research blood/tissue samples and clinicopathological information. Exclusion Criteria: 1. Radical gastrectomy was found cannot be achieved during operation due to metastasis or adjacent organ invasion. 2. Only preoperative or postoperative blood sample was harvest or qualified. 3. No qualified paired tissue samples. 4. No complete clinicopatholoical information and follow-up. 5. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
References
Publications (0)
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