Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06521528

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novomics. Co., Ltd.

Seoul, 07217, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nProfiler I Stomach Cancer Assay Kit

Device

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

Primary outcomes

  1. Timely delivered proportion

    Time frame: 14 days

    the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment

Secondary outcomes

  1. 3-year disease free survival of the enrolled patients.

    Time frame: 3-years after the enrollment completion

    Statistical significance (P value of <0.05)

  2. 5-year overall survival of the enrolled patients.

    Time frame: 5-years after the enrollment completion

    Statistical significance (P value of <0.05)

Sponsors and collaborators

Lead sponsor

Novomics. Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.