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

Novomics

Status: Active, not recruiting

Conditions: Gastric Cancer

Treatments: Device: nProfiler I Stomach Cancer Assay Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT06521528

Feasibility Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 237 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

237 participants in 1 patient group

Feasibility cohort

Description:

patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals.

Treatment:

Device: nProfiler I Stomach Cancer Assay Kit