A Pilot Clinical Study to Evaluate the Feasibility of Using the SPC Test

A Pilot Clinical Study to Evaluate the Feasibility of Using the Single Patient Classifier as a Prognostic Test in Stage II-III Gastric Cancer Patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06521528

Enrollment

237

Registered

2024-07-26

Start date

2019-09-01

Completion date

2025-12-31

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Brief summary

Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. In this study, we evaluated the clinical feasibility of the Single Patient Classifier (SPC) test, a new clinical-grade prognostic assay, in stage II-III gastric cancer patients.

Detailed description

A prospective multicenter study was conducted, involving 237 patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. The SPC test was employed to stratify patients into risk groups, and its feasibility and performance were evaluated. The primary endpoint was the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment. Furthermore, 3-year disease-free survivals of risk groups were analyzed.

Interventions

DEVICEnProfiler I Stomach Cancer Assay Kit

nProfiler I Stomach Cancer Assay Kit (Novomics Co., Korea)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* being ≥19 years of age * having a histologically confirmed diagnosis of stage II or III AGC according to the American Joint Committee on Cancer (AJCC) staging system (sixth edition) * underwent radical gastrectomy without prior neo-adjuvant chemoradiotherapy and did not receive adjuvant chemotherapy * having no visually or microscopically detectable residual tumors.

Exclusion criteria

-Those with insufficient quantity or quality of ribonucleic acid (RNA) for analysis were excluded from the study.

Design outcomes

Primary

Measure	Time frame	Description
Timely delivered proportion	14 days	the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment

Secondary

Measure	Time frame	Description
3-year disease free survival of the enrolled patients.	3-years after the enrollment completion	Statistical significance (P value of \<0.05)
5-year overall survival of the enrolled patients.	5-years after the enrollment completion	Statistical significance (P value of \<0.05)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026