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NCT03403296
A Validation Study of Relationships Among Genomic Gene Expression Profile, Prognosis and Prediction of Adjuvant Chemotherapy Benefit With Capecitabine and Oxaliplatin in Gastric Cancer Stage II and III (6th AJCC) Patients After D2 Surgery (CLASSIC)
trial testing nProfiler I Stomach Cancer Assay Kit in Stage II-III Gastric Cancer in 640 participants. Completed in 12 July 2017.
12 July 2017
Quick facts
| Lead sponsor | Yonsei University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 640 |
| Start date | 13 July 2016 |
| Primary completion | 12 July 2017 |
| Estimated completion | 12 July 2017 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- nProfiler I Stomach Cancer Assay Kit
Conditions studied
- Stage II-III Gastric Cancer — all drugs for Stage II-III Gastric Cancer →
Sponsor
Yonsei University
Who can join
18 and older, any sex, with Stage II-III Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to validate a pre-defined single-patient classifier algorithm for predicting prognosis and benefit from adjuvant chemotherapy for patients who underwent D2 gastrectomy for stage II and III gastric cancer. This algorithm classifies gastric cancer into five groups according to its molecular characteristics based on RNA expression levels. The prognosis and response from adjuvant chemotherapy will be different according to prognostic and predictive clusters respectively based on these groups, thus this algorithm can identify as patients which will have benefit from adjuvant chemotherapy or which will not. Consequently, this algorithm can be translated into clinical practice to help doctors who decide the necessity of adjuvant chemotherapy after D2 gastrectomy for patients who had diagnosed stage II and III gastric cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03403296
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of nProfiler I Stomach Cancer Assay Kit
Trials testing the same drug.
- NCT04600518 — Single Patient Classifier (SPC) Prediction for Stage II and III Advanced Gastric Cancer · completed
- NCT04487717 — Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer · active not recruiting
- NCT06521528 — A Pilot Clinical Study to Evaluate the Feasibility of Using the SPC Test · active not recruiting
Other recruiting trials for Stage II-III Gastric Cancer
Currently open trials in the same condition.
- NCT06609759 — Postoperative Adjuvant Therapy for Stage II-III Gastric Cancer · recruiting
- NCT06157216 — Minimal Residual Disease-guided Adjuvant Therapy for Gastric Cancer · NA · active not recruiting
Other Yonsei University trials
Trials by the same sponsor.
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- NCT07506629 — Adductor Canal Block Methods in Bilateral Total Knee Arthroplasty · NA · not yet recruiting
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- NCT07507188 — Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03403296 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yonsei University
- Last refreshed: 18 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03403296.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing