Last reviewed · How we verify
NCT03485105
Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer
trial in Gastric Cancer in 1,000 participants. Status unknown.
1 October 2019
Quick facts
| Lead sponsor | Yonsei University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 November 2017 |
| Primary completion | 1 October 2019 |
| Estimated completion | 1 November 2019 |
| Sites | 1 location across South Korea |
Conditions studied
- Gastric Cancer — all drugs for Gastric Cancer →
Sponsor
Yonsei University
Who can join
Adults 20 to 85, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To conduct a retrospective study to prove a hypothesis of "adjuvant chemotherapy provides survival benefit for patients of CTX-benefit group in gastric cancer of pT1N1, especially in high-risk group". This study is a pilot study and the result will be used as a reference for the upcoming prospective randomized controlled trial for same issue including estimating sample size. Two high-volume hospitals (Yonsei University Severance Hospital and Samsung Hospital) will participant this pilot study. FFPE sample blocks and clinical information pertaining to the patients who satisfied with selection criteria will be collected from two institutions. The primary end point of this study is disease-free survival (DFS) that is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first; and overall survival (OS) that is defined as time from surgery to death by any causes. Clinical information such as age, sex, histology, Lauren classification, depth of invasion, number of retrieved and metastatic lymph nodes, sizes of tumor, location of tumor, gross type, lympho-vascular invasion, received chemotherapy or not will be centralized. One or 2 of 3mm core of tumor will be punched from FFPE and it will be delivered through Eppendorf tube to laboratory (Novomics Co. Ltd., Seoul, Korea). RNA will be extracted from the tissue and the pattern of RNA expression will be evaluated and each sample will be categorized into three risk group (high, intermediate, low risk group) and two predictive group (CTX-benefit and no-benefit group) by GMP-grade nProfiler 1TM Stomach Cancer Assay Kit (Novomics Co. Ltd., Seoul, Korea). Both clinical information and classification will be delivered to independent statisticians who are responsible to conduct statistical analyses.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Single patient classifier as a prognostic biomarker in pT1N1 gastric cancer: Results from two large Korean cohorts.
Choi YY, Jang E, Kim H, Kim KM, et al · · 2021 · cited 4× · PMID 34815632 · DOI 10.21147/j.issn.1000-9604.2021.05.05
Verify or expand the search:
- PubMed search for NCT03485105
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastric Cancer
Currently open trials in the same condition.
- NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
- NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
- NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting
Other Yonsei University trials
Trials by the same sponsor.
- NCT07547592 — Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma · Phase 2 · not yet recruiting
- NCT07524101 — Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD · NA · not yet recruiting
- NCT07506629 — Adductor Canal Block Methods in Bilateral Total Knee Arthroplasty · NA · not yet recruiting
- NCT07515716 — Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia · NA · not yet recruiting
- 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 NCT03485105 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 9 April 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/NCT03485105.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing