Clinical trial NCT06342427: Stomach Cancer Exosome-based Detection
Official title: Early Detection of Stomach Cancer With a Liquid Biopsy Based on Exosomal Micro-RNA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Gastric Adenocarcinoma
Gastric Cancer Stage
Gastric Neoplasm
Gastric Lesion
Gastric Cancer in Situ
Gastric Cancer Stage IV
Gastric Cancer Stage IIIB
Gastric Cancer Stage III
Gastric Cancer Stage IB
Gastric Cancer Stage IA
Gastric Cancer, Stage 0
Gastric Cancer Stage IIIA
Gastric Cancer Stage II
Gastric Cancer TNM Staging
Gastric Cancer Metastatic to Lung
Gastric Cancer Metastatic to Liver
Gastric Cancer Stage I
Gastric Cancer TNM Staging Primary Tumor (T) T2B
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two cohorts of individuals with and without gastric cancer (cases and controls, respectively)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Specificity
timeFrame: Through study completion, an average of 1 year
measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Nagoya
country: Japan
facility: Nagoya University
city: Tsu
country: Japan
facility: Mie University
Study officials:
affiliation: City of Hope Medical Center
name: Ajay Goel, PhD
role: PRINCIPAL_INVESTIGATOR
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