ClinicalTrials.Veeva

Menu

Stomach Cancer Exosome-based Detection (DESTINEX)

City of Hope logo

City of Hope

Status

Completed

Conditions

Gastric Cancer, Stage 0
Gastric Cancer Stage IV
Gastric Cancer Stage IIIA
Gastric Neoplasm
Gastric Lesion
Gastric Cancer TNM Staging Primary Tumor (T) T2B
Gastric Cancer TNM Staging
Gastric Cancer Stage I
Gastric Cancer Stage IB
Gastric Cancer Metastatic to Lung
Gastric Adenocarcinoma
Gastric Cancer Stage IA
Gastric Cancer Metastatic to Liver
Gastric Cancer in Situ
Gastric Cancer Stage IIIB
Gastric Cancer
Gastric Cancer Stage II
Gastric Cancer Stage III
Gastric Cancer Stage

Treatments

Diagnostic Test: DESTINEX

Study type

Observational

Funder types

Other

Identifiers

NCT06342427
23228/DESTINEX

Details and patient eligibility

About

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.

Full 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.

Enrollment

809 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

809 participants in 4 patient groups

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

Trial contacts and locations

3

Loading...

Central trial contact

Ajay Goel, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems