Stomach Cancer Exosome-based Detection (DESTINEX)

July 3, 2024 updated by: City of Hope Medical Center

Early Detection of Stomach Cancer With a Liquid Biopsy Based on Exosomal Micro-RNA

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. Because conventional endoscopy is invasive and costly, gastric cancer is currently not considered to be screenable at a population level. However, if one could find less invasive and cheaper tools that accurately detect gastric cancer in its early stages, it could make a significant difference. Accurate biomarkers could help identify patients with gastric cancer before it becomes incurable.

This study aims to develop a non-invasive test to detect gastric cancer early. It consists of four phases:

  1. Discovering potential biomarkers with a comprehensive and genome-wide transcriptomic sequencing analysis that will involve gastric cancer tissue, normal tissue, and serum samples from patients with gastric cancer, as well as samples from people without the disease.
  2. Using machine learning to develop a combination "signature" of cell-free (cf) and exosomal (exo)-miRNA in serum specimens from a training cohort.
  3. A validation of this signature in an independent cohort to confirm its accuracy.
  4. An evaluation of the temporal trend of this signature in paired samples collected pre-surgery and post-surgery to investigate their potential and specificity as indicators of minimal residual disease.

In summary, this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early. Success could lead to significant improvements in clinical practice by catching cancer when it is most treatable. By combining different genetic markers (cell-free microRNA and exosomal microRNA) for accuracy, this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future.

Study Type

Observational

Enrollment (Actual)

809

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

  • Japan
      • Nagoya, Japan
        • Nagoya University
      • Tsu, Japan
        • Mie University
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Two cohorts of individuals with and without gastric cancer (cases and controls, respectively)

Description

Inclusion Criteria:

  • Histological diagnosis of stage I, II, III, IV gastric cancer (TNM classification, 8th edition) (cases).
  • Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
  • Confirmed cancer-free status at the time of study inclusion (Non-disease controls).

Exclusion Criteria:

  • Lack of written informed consent.
  • Systemic therapy before sampling.
  • Synchronous gastric and non-gastric cancer diagnosed at or before surgery.

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
Patients with Gastric Cancer (Training)
Individuals with a pathologically confirmed diagnosis of gastric cancer
Diagnostic test: DESTINEX
A panel of microRNA, whose expression level is tested in serum samples.
Other Names:
  • DESTINEX (DEtection of STomach NEoplasia in circulating eXosomes)
Patients without Gastric Cancer (Training)
Individuals without cancer at the time of blood sampling
Diagnostic test: DESTINEX
A panel of microRNA, whose expression level is tested in serum samples.
Other Names:
  • DESTINEX (DEtection of STomach NEoplasia in circulating eXosomes)
Patients with Gastric Cancer (Validation)
Individuals with a pathologically confirmed diagnosis of gastric cancer
Diagnostic test: DESTINEX
A panel of microRNA, whose expression level is tested in serum samples.
Other Names:
  • DESTINEX (DEtection of STomach NEoplasia in circulating eXosomes)
Patients without Gastric Cancer (Validation)
Individuals without cancer at the time of blood sampling
Diagnostic test: DESTINEX
A panel of microRNA, whose expression level is tested in serum samples.
Other Names:
  • DESTINEX (DEtection of STomach NEoplasia in circulating eXosomes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Through study completion, an average of 1 year
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: Through study completion, an average of 1 year
True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)
Time Frame: Through study completion, an average of 1 year
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Ajay Goel, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 15, 2023

Primary Completion (Actual)

June 15, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/DESTINEX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

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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