Stomach Cancer Exosome-based Detection

Completed

• Conditions: Gastric Cancer Stage III; Gastric Cancer Stage IB; Gastric Cancer TNM Staging; Gastric Cancer; Gastric Cancer in Situ; Gastric Cancer, Stage 0; Gastric Lesion; Gastric Cancer Stage IV; Gastric Cancer Stage IIIA; Gastric Cancer Metastatic to Lung
• Interventions: Diagnostic Test: DESTINEX

• Registration Number: NCT06342427
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2023-03-15
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-02
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 809

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Gastric Cancer (Validation)	DESTINEX	Individuals with a pathologically confirmed diagnosis of gastric cancer
Patients with Gastric Cancer (Training)	DESTINEX	Individuals with a pathologically confirmed diagnosis of gastric cancer
Patients without Gastric Cancer (Training)	DESTINEX	Individuals without cancer at the time of blood sampling
Patients without Gastric Cancer (Validation)	DESTINEX	Individuals without cancer at the time of blood sampling

Primary Outcome Measures

Name	Time	Method
Sensitivity	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

Secondary Outcome Measures

Name	Time	Method
Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)	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
Specificity	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

Trial Locations

Locations (3)

Mie University; 🇯🇵 Tsu, Japan

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

Nagoya University; 🇯🇵 Nagoya, Japan