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

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Oxaliplatin

Fluorouracil

Capecitabine

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Traditional Chinese Medicine oral taken twice a day for at least 3 months combined with chemotherapy.

The chemotherapy can choose intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21 days; or intravenous oxaliplatin 100 mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 40mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 50mg/m(2) on day 1 plus intravenous oxaliplatin 85 mg/m(2) on day 1 plus 5-FU intravenously CIV24h on day 1, every 14 days; Each participant shoud take eight (8) cycles of chemotherapy.

The chemotherapy can choose intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21 days; or intravenous oxaliplatin 100 mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 40mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 50mg/m(2) on day 1 plus intravenous oxaliplatin 85 mg/m(2) on day 1 plus 5-FU intravenously CIV24h on day 1, every 14 days; Each participant shoud take eight (8) cycles of chemotherapy.

TCM decoction orally taken twice a day for at least 3 months

5-FU

Aiguang Zhao, M.D.,Ph.D

This is a randomized, open-label study done in 3 hospitals in China. Patients with stage IIIB and IIIC gastric cancer who undergo curative D2 gastrostomy will be randomly assigned after surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant chemotherapy combined Traditional Chinese treatment. The primary outcome was disease-free survival and 3-year disease-free survival rate in the intention-to-treat population.

The purpose of this study is to evaluate the Traditional Chinese Medicine combined adjuvant chemotherapy in the treatment of stage IIIb and IIIc gastric cancer through randomized controlled trial.

Metastasis and recurrence is the primary cause in decreasing the survival time of gastric cancer patients who experienced radical operation. Among whom, patients with stage IIIB and IIIC are especially in high risk of metastasis and recurrence, result in a significant poor survival time than patients with earlier stages.

Oxaliplatin with capecitabine is the standard adjuvant chemotherapy for curative D2 gastrostomy gastric cancer, contribute the 3-year disease free survival rate of 74% in ITT, and 61% in stage IIIB sub-group. Meanwhile, Traditional Chinese Medicine (TCM) treatment has been used for thousands of years in Chinese clinical practices. In China, the clinical curative effect of TCM in the treatment of gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the TCM is effective and safety for gastric cancer.In order to evaluate efficacy on TCM combined adjuvant chemotherapy in IIIB and IIIC gastric cancer, we design this randomized, open-label study.

The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer

The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer: A Randomized Controlled Trial

The rate refers to cases that see first tumor metastasis or recurrence or death of any cause from randomization.

Using NCI-CTC standard to record adverse effects of chemotherapy and treatments.

Using the EORTC QLQ-C30 scale (European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30) to evaluate the quality of life of patients. The scale includes 14 aspects: physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial problem, with each aspect scores from one point to four points (lower points represent a better quality of life), and a general quality of life scores from one point to seven points (higher points represent a better quality of life).

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
The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer	NCT03607656	Gastric Cancer ... Gastric Cancer ...	Oxaliplatin Capecitabine TCM S-1 Docetaxel 5-FU	18 Years - 80 Years	Shanghai University of Traditional Chinese Medicine

Spots Global Cancer Trial Database for gastric cancer stage iiib