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

NCT06521528 | Active Not Recruiting

• 1 other identifier: Feasibility Study
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Timely delivered proportion

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

  14 days

Secondary Outcomes (2)

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

  3-years after the enrollment completion

• 5-year overall survival of the enrolled patients.

  5-years after the enrollment completion

Study Arms (1)

Feasibility cohort

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

Device: nProfiler I Stomach Cancer Assay Kit

Interventions

nProfiler I Stomach Cancer Assay Kit DEVICE

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

Feasibility cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

histologically confirmed diagnosis of stage II or III AGC

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novomics. Co., Ltd.: lead

Study Sites (1)

Novomics. Co., Ltd.

Seoul, 07217, South Korea

Location

Biospecimen

Retention: NONE RETAINED

FFPE samples

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Young-Woo Kim, MD., Ph.D

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2019
• Primary Completion: August 30, 2020
• Study Completion: December 31, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

KR (1)