Clinical trial · Observational
Single Patient Classifier (SPC) Prediction for Stage II and III Advanced Gastric Cancer
A Retrospective, Multi-center, Single-blind, Pivotal Trial to Assess Clinical Equivalence With Stage II and III Advanced Gastric Cancer Based on the 6th and 8th of the AJCC
NCT04600518CI-TRIAL-00078984SPRINTcompletedClinicalTrials.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)
A retrospective, multi-center, single-blind, pivotal trial to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
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
- SPRINT cohort
- description
- stage II and III advanced gastric cancer patients based on the 6th and 8th of the AJCC
- interventionNames
- Device: nProfiler I Stomach Cancer Assay Kit
Primary outcomes (3)
- measure
- Differences in prognosis
- timeFrame
- 5 years after the date of surgery for patients in Low risk group and High risk group
- description
- Differences in prognosis between Low risk group and High risk group (AJCC 8th, Advanced gastric cancer stage II and III)
- measure
- Comparability of prognostic stratification
- timeFrame
- 5 years after the date of surgery for patients in Low risk group and High risk group
- description
- Comparability of prognostic stratification with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
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 * Postoperative patients with gastric cancer invading the submucosal layer and having 3 or more lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria and lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC) * Patients who have not received neoadjuvant chemotherapy and radiotherapy * Patients with pathological record and clinical information after surgery from archived FFPE(formalin-fixed paraffin-embedded) samples between 2005 and 2010 * Patients who have not been included in discovery clinical trial and confirmatory clinical trial * 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 2. Sample criteria * The 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 * Postoperative patients with gastric cancer invading the mucosa and submucosal layer and having less than 3 lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria without lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC) * Patients who have received neoadjuvant chemotherapy or radiotherapy * Patients without pathological record and clinical information after surgery from archived FFPE samples between 2005 and 2010 * Patients who have been included in discovery clinical trial and confirmatory clinical trial * Patients with residual tumors after surgery 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.