Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma in Situ

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Individuals with a pathologically confirmed diagnosis of gastric cancer

Individuals without cancer at the time of blood sampling

A panel of microRNA, whose expression level is tested in serum samples.

DESTINEX

Ajay Goel, PhD

Silei Sui

Caiming Xu

Yasuhiro Kodera

Mitsuo Kanda

Yuji Toiyama

Yoshinaga Okugawa

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.

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.

Formalin-fixed and paraffin-embedded tissue samples Serum

Stomach Cancer Exosome-based Detection

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

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

True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

City of Hope Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

One of the study tumors.Between February 1, 2015 and May 19, 2018, 356adult patients with gastric adenocarcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University, of them, 110 patients with lung metastasis. 28 patients with lung cavitation

One of the study tumors.Between February 1, 2015 and May 19, 2018, 77 adult patients with primary lung cancer, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. 30 of 77 were squamous cell carcinoma and 47 of 77 were adenocarcinoma. 28 patients with lung cavitation.

apatinib treated patients developed lung cavitation

lung cavitation

The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database. All patients were with Karnofsky performance status ≥70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions. Cardiac disease and hemorrhagic disease were excluded. All patients had pre-therapy chest computed tomography (CT) prior to apatinib treatment, and follow-up chest CT at least every 4 weeks. The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here. Other patient demographic and clinical data, including age, gender; stage of disease, apatinib administered inclusion and withdrawal date, adverse events, oncologic clinical response, comorbid conditions, and smoking history, were retrieved from the CRIS database.

Study for Patients With Lung Metastatic Advanced Gastric Cancer and NSCLC Treated With Apatinib

A Retrospective Study for Patients With Lung Metastatic Advanced Gastric Cancer or NSCLC Treated With Apatinib

Evaluation of the oncologic clinical response was based on the alternate, modified method. We concluded that incorporating an assessment of cavitation when measuring target lesions might more accurately reflect changes in tumor volume. It was used for target lesions in which the longest diameter of any cavitation (zero if no cavity presented) was subtracted from the longest total diameter of the lesion, with each measurement taken in the same plane, to provide an alternate measure that was used to calculate the sum of measurements for all target lesions.

For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Stomach Cancer Exosome-based Detection	NCT06342427	Gastric Cancer Gastric Adenoca... Gastric Cancer ... Gastric Neoplas... Gastric Lesion Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer,... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ...	DESTINEX	18 Years -	City of Hope Medical Center
Study for Patients With Lung Metastatic Advanced Gastric Cancer and NSCLC Treated With Apatinib	NCT03629691	Gastric Cancer ... Lung Cancer	lung cavitation	18 Years - 90 Years	The Affiliated Hospital of Qingdao University

Spots Global Cancer Trial Database for gastric cancer metastatic to lung