Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer (PREDICT)

March 22, 2023 updated by: Novomics. Co., Ltd.
Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response for resectable gastric cancer

Study Overview

Status

Recruiting

Conditions

Detailed Description

  1. Background: According to Global Cancer Statistics of International Agency for Research on Cancer under World Health Organization, stomach cancer is the fifth most common cancer as there were over 1 million new cases in 2018 and the third leading cause of cancer death by 783,000 people are estimated to die of stomach cancer. In Korea, gastric cancer is the most frequent cancer in 13.3% of all cancer cases by the report of Korea Central Cancer Registry in 2018. Since 2010, adjuvant chemotherapy with advanced gastric cancer stage 2 and stage 3 patients following gastrectomy has become a standard treatment through clinical validation of increasing the patient's survival rate. However, even in the second and third stages of the same stomach cancer, the biological properties may be different.

  2. Purpose:

    The nProfiler® 1 Stomach Cancer Assay is a molecular diagnostic test to predict the prognosis for patients with stage Ⅱ-Ⅲ advanced gastric cancer. This study will evaluate the clinical utility of nProfiler® 1 Stomach Cancer Assay by recruiting subjects from multi centers and observing the 5-year survival rates of Low risk, Intermediate risk, High risk according to gastric cancer prognostic molecular diagnostic test.

  3. Study Procedure:

    • Obtaining of informed consent form
    • Review of provider's eligibility/ Sample preparation and delivery
    • Sample criteria evaluation
    • Subject enrollment
    • Gastric cancer prognostic prediction molecular diagnostic test
    • Prognostic group result report
    • 5-yr survival follow-up
    • Statistical analysis
  4. Outcome Measures:

The following efficacy outcome measures will be assessed:

  • Primary efficacy outcome measure

    :High risk and low risk group's 5-yr Overall Survival(OS) rate

  • Secondary efficacy outcome measure

    • High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate
    • Intermediate risk group's 5-yr OS and 3-yr DFS rate
    • Subgroup analysis : Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr DFS rate)

Study Type

Observational

Enrollment (Anticipated)

688

Contacts and Locations

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

Study Contact

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

Genders Eligible for Study

All

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
    • Patients with histologically confirmed gastric adenocarcinoma
    • Patients with histologically confirmed stage Ⅱ or Ⅲ
    • Patients who have undergone radical gastrectomy
    • Patients who have not received neoadjuvant chemotherapy and radiotherapy
    • 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
    • Patients who have signed a written consent of the study and signed a human derived research agreement (Form 34)

  2. Sample criteria

    • The formalin-fixed paraffin-embedded (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
    • Patients with histologically not confirmed gastric adenocarcinoma
    • Patients with histologically confirmed stage Ⅰ or Ⅳ
    • Patients who have not undergone radical gastrectomy
    • Patients who have received neoadjuvant chemotherapy or radiotherapy
    • Patients with distant or peritoneal metastasis at the time of surgery or residual tumors after surgery
    • Patients who have not signed the study's written consent and human derived research agreement (Form 34)

  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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Low risk
good prognosis
Intermediate risk
moderate prognosis
High risk
poor prognosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic group's 5-yr Overall Survival(OS) rate
Time Frame: 5 years after last registered patient
High risk and low risk group's 5-yr Overall Survival(OS) rate
5 years after last registered patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic group's 3-yr Disease Free Survival(DFS) rate
Time Frame: 3 years after last registered patient
High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate Intermediate risk group's 5-yr Os and 3-yr DFS rate
3 years after last registered patient
Subgroup analysis
Time Frame: 3, 5 years after last registered patient
Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr DFS rate)
3, 5 years after last registered patient

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)

July 29, 2020

Primary Completion (Anticipated)

October 31, 2026

Study Completion (Anticipated)

January 29, 2027

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NM-CTP-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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