Single Patient Classifier (SPC) Prediction for Stage II and III Advanced Gastric Cancer (SPRINT)

July 19, 2024 updated by: Novomics. Co., Ltd.

A Retrospective, Multi-center, Single-blind, Pivotal Trial to Assess Clinical Equivalence With Stage II and III Advanced Gastric Cancer Based on the 6th and 8th of the AJCC

A retrospective, multi-center, single-blind, pivotal trial to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The safety and effectiveness of nProfiler® 1 Stomach Cancer Assay have been evaluated with stage II and III advanced gastric cancer patients based on the 6th of the American Joint Committee on Cancer (AJCC) through discovery clinical trial (418 patients) and confirmatory clinical trial (684 patients).

The goal of this study, a retrospective, multi-center, single-blind, pivotal trial, is to assess clinical equivalence with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC and to evaluate prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group.

The study will follow these procedures; Sample screening, Sample Preparation and Sample Criteria Evaluation, Sample enrollment, nProfiler® 1 Stomach Cancer Assay (gastric cancer prognosis prediction), Prognostic Result Report, and Evaluation of Clinical Performance.

Study Type

Observational

Enrollment (Actual)

2047

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

19 years or older patients with stage II, III gastric adenocarcinoma

Description

Inclusion Criteria:

  1. Sample providers criteria

    • Male and female adult patients aged 19 years or over
    • Postoperative patients with gastric cancer invading the submucosal layer and having 3 or more lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria and lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
    • Patients who have not received neoadjuvant chemotherapy and radiotherapy
    • Patients with pathological record and clinical information after surgery from archived FFPE(formalin-fixed paraffin-embedded) samples between 2005 and 2010
    • Patients who have not been included in discovery clinical trial and confirmatory clinical trial
    • Patients who have undergone a radical gastrectomy and who show no evidence of residual tumors as observed with the unaided eye or through a microscope

  2. Sample criteria

    • The FFPE tumor specimens in storage have a tumor amount of at least 20% and therefore can be tested.
    • The quantity (not less than 400ng) and quality (A260/280 of not less than 1.8) of RNA are sufficient for analysis.

Exclusion Criteria:

  1. Sample providers criteria

    • Male and female patients aged less than 19 years
    • Postoperative patients with gastric cancer invading the mucosa and submucosal layer and having less than 3 lymph nodes metastasis or who with gastric cancer infiltration of muscularis propria without lymph node metastasis (stage II and III advanced gastric cancer patients, 8th of the AJCC)
    • Patients who have received neoadjuvant chemotherapy or radiotherapy
    • Patients without pathological record and clinical information after surgery from archived FFPE samples between 2005 and 2010
    • Patients who have been included in discovery clinical trial and confirmatory clinical trial
    • Patients with residual tumors after surgery

  2. Sample criteria

    • The FFPE tumor specimens in storage have a tumor amount of less than 20% and therefore cannot be tested
    • The quantity and quality of RNA are not sufficient for analysis

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
SPRINT cohort
stage II and III advanced gastric cancer patients based on the 6th and 8th of the AJCC
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
Differences in prognosis
Time Frame: 5 years after the date of surgery for patients in Low risk group and High risk group
Differences in prognosis between Low risk group and High risk group (AJCC 8th, Advanced gastric cancer stage II and III)
5 years after the date of surgery for patients in Low risk group and High risk group
Comparability of prognostic stratification
Time Frame: 5 years after the date of surgery for patients in Low risk group and High risk group
Comparability of prognostic stratification with stage II and III advanced gastric cancer based on the 6th and 8th of the AJCC
5 years after the date of surgery for patients in Low risk group and High risk group
Prognostic equivalence
Time Frame: 5 years after the date of surgery for patients in surgery only group and adjuvant chemotherapy group in Low risk group
Prognostic equivalence between surgery only group and adjuvant chemotherapy group in Low risk group
5 years after the date of surgery for patients in surgery only group and adjuvant chemotherapy group in Low risk group

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multivariate analysis
Time Frame: 5 years after the date of surgery for patients with stage II-III advanced gastric cancer (8th of the AJCC)
Multivariate analysis with age, sex, TNM stage, adjuvant-chemotherapy
5 years after the date of surgery for patients with stage II-III advanced gastric cancer (8th of the AJCC)

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)

October 7, 2020

Primary Completion (Actual)

June 18, 2023

Study Completion (Actual)

June 22, 2023

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NM-CTP-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug 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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