Clinical trial · Observational
Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer
NCT04487717CI-TRIAL-00083841PREDICTactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response for resectable 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 |
|---|---|---|---|
| nProfiler I Stomach Cancer Assay Kit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PREDICT cohort
- description
- Patients with pathologic stage II, III advanced gastric cancer
- interventionNames
- Device: nProfiler I Stomach Cancer Assay Kit
Primary outcomes (1)
- measure
- Prognostic group's 5-yr Overall Survival(OS) rate
- timeFrame
- 5 years after last registered patient
- description
- High risk and low risk group's 5-yr Overall Survival(OS) rate
Secondary outcomes (2)
- measure
- Prognostic group's 3-yr Disease Free Survival(DFS) rate
- timeFrame
- 3 years after last registered patient
- description
- High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate Intermediate risk group's 5-yr Os and 3-yr DFS rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sample providers criteria * Male and female adult patients aged 19 years or over * Patients with histologically confirmed gastric adenocarcinoma * Patients with histologically confirmed stage Ⅱ or Ⅲ * Patients who have undergone radical gastrectomy * Patients who have not received neoadjuvant chemotherapy and radiotherapy * Patients who have undergone a radical gastrectomy and who show no evidence of residual tumors as observed with the unaided eye or through a microscope * Patients who have signed a written consent of the study and signed a human derived research agreement (Form 34) 2. Sample criteria * The formalin-fixed paraffin-embedded (FFPE) tumor specimens in storage have a tumor amount of at least 20% and therefore can be tested. * The quantity (not less than 400ng) and quality (A260/280 of not less than 1.8) of RNA are sufficient for analysis. Exclusion Criteria: 1. Sample providers criteria * Male and female patients aged less than 19 years * Patients with histologically not confirmed gastric adenocarcinoma * Patients with histologically confirmed stage Ⅰ or Ⅳ * Patients who have not undergone radical gastrectomy * Patients who have received neoadjuvant chemotherapy or radiotherapy * Patients with distant or peritoneal metastasis at the time of surgery or residual tumors after surgery * Patients who have not signed the study's written consent and human derived research agreement (Form 34) 2. Sample criteria * The FFPE tumor specimens in storage have a tumor amount of less than 20% and therefore cannot be tested * The quantity and quality of RNA are not sufficient for analysis
References
Publications (0)
Data not yet available
No reference posted for this study.