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

NCT ID: NCT06521528

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Feasibility cohort

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

nProfiler I Stomach Cancer Assay Kit

Intervention Type DEVICE

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

Interventions

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nProfiler I Stomach Cancer Assay Kit

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novomics. Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young-Woo Kim, MD., Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

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Novomics. Co., Ltd.

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Feasibility Study

Identifier Type: -

Identifier Source: org_study_id

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