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Stomach Neoplasms clinical trials

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NCT ID: NCT04869618 Recruiting - Gastric Cancer Clinical Trials

Validation of an Artificial Intelligence System Based on Raman Spectroscopy for Diagnosis of Gastric Premalignant Lesions and Early Gastric Cancer

Start date: May 2021
Phase: N/A
Study type: Interventional

Early detection and treatment of gastric premalignant lesion and early gastric cancer (EGC) have been proposed to improve outcomes of gastric cancer. Gastric dysplasia is a premalignant lesion and the penultimate stage in gastric carcinogenesis. On white light endoscopy (WLE), it is difficult to distinguish gastric dysplasia and EGC from benign pathology such as gastric intestinal metaplasia (GIM). Image enhanced endoscopy such as narrow-band imaging (NBI) is recommended to improve characterization of suspicious gastric lesions detected on WLE. Magnified-endoscopy with NBI (ME-NBI) have been shown to be superior to HD-WLE for diagnosis of GIM and EGC. Data on gastric dysplasia is less robust. Ultimately, biopsy is required to confirm diagnosis of gastric dysplasia/EGC. Gastric dysplasia can be classified into low-grade dysplasia (LGD) or high-grade dysplasia (HGD). Biopsy sampling may not be representative of the final histopathological grade of resected specimens and may under-stage dysplasia. Thus, endoscopic resection (ER) is recommended for gastric dysplasia and EGC on biopsy for diagnostic and therapeutic purpose. The current gap is to improve concordance of endoscopic and histologic findings of gastric dysplasia and early gastric cancer. Raman spectroscopy based artificial intelligence system (SPECTRA IMDx) was developed to provide an objective method to identify patients with gastric premalignant lesions and EGC. SPECTRA IMDx interrogate tissues at the cellular level and utilizes molecular information to provide actionable information to endoscopist during gastroscopy. Studies on diagnostic performance using Raman spectroscopy analysis devices have shown high sensitivity and specificity in detection of gastric cancer and precancerous lesions compared to WLE. However, these studies included few GIM, gastric dysplasia and gastric carcinoma. It is still unclear if Raman spectroscopy outperforms WLE in diagnosis of gastric HGD and EGC. In addition, the Raman spectroscopy algorithm is only able to characterize lesions into high risk (HGD/EGC) versus low risk (GIM/LGD/Gastritis/Normal). It is also uncertain if this technology is able to differentiate GIM and LGD. We plan to conduct a prospective trial to validate the diagnostic accuracy of SPECTRA for prediction of gastric HGD and EGC prior to gastric ER. Hypothesis: SPECTRA IMDx is able to differentiate higher risk lesions (HGD/EGC) from lower risk tissue/lesion (GIM/LGD/Gastritis/Normal)

NCT ID: NCT04868747 Withdrawn - Gastric Cancer Clinical Trials

The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping after minimally invasive surgery for stomach cancer

NCT ID: NCT04861987 Active, not recruiting - Advanced Cancer Clinical Trials

A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors

Start date: June 18, 2021
Phase: Phase 1
Study type: Interventional

This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.

NCT ID: NCT04859582 Withdrawn - Stomach Neoplasms Clinical Trials

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension

Start date: November 8, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult Chinese participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

NCT ID: NCT04852679 Completed - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumor

Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs

PALACE
Start date: May 24, 2021
Phase: Phase 3
Study type: Interventional

This study will be conducted to support the registration of the lanreotide Autogel 120 mg formulation in China for the treatment of GEP-NETs and treatment of clinical symptoms of NETs. The study will include a screening period of up to 4 weeks followed by a 48-week intervention period. After completion of the main study period, approximately five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.

NCT ID: NCT04850716 Recruiting - Gastric Cancer Clinical Trials

Relationship Between Standard Treatment Efficacy and The Tumor Microenvironment in Advanced Gastric Cancer

Start date: April 27, 2021
Phase:
Study type: Observational

Gastric cancer is among the most common malignant tumors nationwide with high morbidity and mortality. Attributing to its insidious onset and rapid progress, 70% of patients with gastric cancer were initially diagnosed at an advanced stage. In advanced gastric cancer, systemic treatment based on chemotherapy drugs, targeted drugs, and immune checkpoint inhibitors remains the main regimens. Among current standard treatment regimens, though HER2-positive and MSI-H/dMMR statuses indicate the treatment efficacy of trastuzumab and immune checkpoint inhibitors, there is still lack of robust biomarkers for predicting treatment efficacy. Tumor microenvironment as pivotal components of solid tumor, significantly influences therapeutic response and clinical outcome. The study is a multi-center, observational study to evaluate the relationship between standard treatment efficacy and the tumor microenvironment in advanced gastric cancer. In addition, the study comprehensively evaluated the landscape of the tumor microenvironment characteristics of gastric cancer, and aimed at establishing robust biomarkers for predicting prognosis and treatment efficacy to finetune treatment strategies.

NCT ID: NCT04843397 Not yet recruiting - Gastric Cancer Clinical Trials

Diagnostic Performance Indicators in Upper GI Endoscopy:PROSPERO Study

PROSPERO
Start date: June 1, 2021
Phase:
Study type: Observational

Cancers of the upper gastro-intestinal tract, including esophagus (gullet), stomach and small bowel, are amongst the deadliest malignancies. The main reason for their high mortality rate is that they are usually diagnosed late when curative treatments are no longer effective. However, these types of cancer generally arise from well-described pre-cancerous diseases, such as Barrett's esophagus and gastric intestinal metaplasia. This provides an opportunity for clinicians to detect these pre-cancerous conditions early and offer adequate cure or clinical monitoring before they progress to cancer. A camera test (gastroscopy) is the gold-standard test to detect pre-cancerous diseases in these organs. There has been limited research to set the standards for performance of a gastroscopy, especially with regards to diagnosis of pre-cancerous conditions, which require knowledge and skills by the physician performing the test (endoscopist). Therefore, the hypothesis behind this study is that the aforementioned pre-cancerous diseases are understudied and often go undetected. This study aims to understand how often endoscopists should diagnose these pre-cancerous diseases on routine gastroscopy and help define the standards to measure performance. The investigators will assess the following rates: i. how often endoscopists diagnose these pre-cancerous lesions during endoscopy; ii. How often these conditions are diagnosed on biopsies taken according to a standardized protocol; iii. How often these condition should have been diagnosed by the endoscopists based on the review of pictures by expert endoscopists. The investigators will also compare the rates of correct diagnosis by endoscopists with different levels of experience and based on the times spent to complete the diagnostic test. Investigating these aspects will enhance the understanding of the medical community with regards to the diagnosis of these pre-cancerous lesions and set endoscopy standards to improve their early detection and treatment before they progress to cancer. This will translate to improved cancer prevention and benefit for patients.

NCT ID: NCT04843215 Recruiting - Gastric Cancer Clinical Trials

A Phase III Study Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.

NCT ID: NCT04842916 Active, not recruiting - Gastric Cancer Clinical Trials

InteGRAtive Analysis of tuMor, Microenvironment, immunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer

GRAMMY
Start date: September 22, 2020
Phase:
Study type: Observational

Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.

NCT ID: NCT04840056 Recruiting - Gastric Cancer Clinical Trials

Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis

GIMA
Start date: April 15, 2021
Phase:
Study type: Observational

The primary objectives of this study are: - To identify clinical or histological factors associated with gastric cancer development in patients with IM and AG - To establish a machine learning algorithm for prediction of future gastric cancer risks and individual risk stratification in patient with IM and AG