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

July 25, 2024 updated by: Novomics. Co., Ltd.

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

237

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

histologically confirmed diagnosis of stage II or III AGC

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Feasibility cohort
patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals.
Device: nProfiler I Stomach Cancer Assay Kit
nProfiler I Stomach Cancer Assay Kit (Novomics Co., Korea)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novomics. Co., Ltd.

Investigators

  • Principal Investigator: Young-Woo Kim, MD., Ph.D, National Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

August 30, 2020

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Feasibility Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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