Table 1 Ongoing studies using ctDNA for detecting gastric cancer
From: Clinical applications and perspectives of circulating tumor DNA in gastric cancer
NCT Number | Study type | Study title | Cohorts/Arms | Primary outcome measures | Numbers of enrollment |
|---|---|---|---|---|---|
NCT04000425 | OBSERVATIONAL | Potential Clinical Utilities of Circulating Tumor DNA in Gastric Cancer | Stomach adenocarcinoma patients who plan to receive radical gastrectomy | Disease recurrence risk; DFS; ctDNA changing to adjuvant chemotherapy response; Time of first negative ctDNA detection from positive ctDNA detection | 55 |
NCT05029869 | OBSERVATIONAL | Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy Study Description | Patients with newly diagnosed and untreated gastric adenocarcinoma | The sensitivity and specificity of MRD detection using ctDNA as the biomarker | 100 |
NCT04053725 | OBSERVATIONAL | Prediction of the Efficacy of ctDNA in Immunotherapy for Advanced Gastric Cancer | Advanced Gastric Cancer Patients with second- or third-line chemotherapy and combined with immunoassay inhibitors | The proportions of patients with positive serum ctDNA that have postoperative relapse | 200 |
NCT02887612 | OBSERVATIONAL | ctDNA for Prediction of Relapse in Gastric Cancer | Early or intermediate-stage gastric cancer patients need to have surgical treatment | Positive Predictive Value; The proportions of patients with positive serum ctDNA that have postoperative relapse | 200 |
NCT05208372 | OBSERVATIONAL | Detection of CTC and ctDNA in the Diagnosis of Metastasis in Gastric Cancer | Borrmann III and Borrmann IV Gastric Cancer patients undergo either laparotomy or laparoscopic surgery | Quantity of CTCs; Expression of ctDNA | 200 |
NCT04520295 | OBSERVATIONAL | ctDNA Screening in Advanced HER2 Positive Gastric Cancer | HER2 positive gastric cancer patients | Change from baseline in molecular biomarkers (gene mutation, amplification and fusion) at time on best overall response | 100 |
NCT04943406 | OBSERVATIONAL | Peritoneal Lavage Liquid Biopsy in Patients with Gastric Cancer | Patients with histologically proven gastric or GEJ Siewert type II and III adenocarcinoma | Prognostic impact (overall survival and disease-free survival) of ctDNA positivity | 150 |
NCT03425058 | OBSERVATIONAL | Molecular Evaluation of Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer | Locally advanced gastric cancer patients without distant metastasis or peritoneal dissemination (T4a/T4bN + M0) | The relationship between dMMR/MSI status and response to neoadjuvant chemotherapy; The concordance and accuracy of response evaluation results determined by ctDNA, CTCs compared with imaging and serum tumor biomarkers (CEA, CA19-9, CA72-4 et al.) | 80 |
NCT05661110 | OBSERVATIONAL | Biomarker Analysis of HIPEC Combined with PD1/PDL1 Inhibitor for Gastric Cancer with Peritoneal Metastasis | Advanced gastric adenocarcinoma confirmed by histology with peritoneal metastasis | Numerical changes and genomic changes of ctDNA during treatment | 46 |
NCT04511559 | OBSERVATIONAL | Methylation Analysis of Circulating Tumor DNA in Gastric Cancer | Healthy volunteers and Gastric Cancer patients with upper GI endoscopy for standard clinical indications | Analysis ctDNA methylation status and its Correlation to early diagnosis and prognostic evaluation of gastric cancer | 540 |
NCT05431621 | OBSERVATIONAL | Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers | Newly-diagnosed patients with digestive system cancers | Establish ctDNA-targeted sequencing models for early detection of esophageal, gastric, colorectal and hepatocellular cancer, and evaluate the diagnosis value | 2430 |
NCT05027347 | OBSERVATIONAL | Detection of Plasma Circulating Tumor DNA in Gastric Cancer | Patients diagnosed with early and locally advanced stage (I, II and IIIA) gastric cancer | The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients | 200 |
NCT05227261 | OBSERVATIONAL | Early Detection of Five Common Cancers Using the ctDNA Analysing Test | Patients with no history of cancer | Positive predictive value, Negative predictive value, sensitivity and specificity of the blood ctDNA test in early detecting cancers | 3000 |
NCT04947995 | OBSERVATIONAL | Multi-Omics Noninvasive Inspection of Tumor Risk for Gastric Cancer | Subjects aged ≥ 40 who will receive EGD | The sensitivity and specificity of blood-based multi-omics assay for early detection of gastric cancer | 450 |
NCT05224596 | OBSERVATIONAL | AssesSment of Early-deteCtion iqui oN iquid Biopsy in GASTRIC Cancer, ASCEND-Gastric | participants in cancer with new diagnosis of gastric cancer; participants in benign disease with new diagnosis of benign gastric disease | Sensitivity and specificity of the cfDNA methylation-based model in detecting gastric cancer | 498 |
NCT05513144 | OBSERVATIONAL | Potential Clinical Utilities of Circulating Tumor DNA in Advanced HER2 Negative Gastric Cancer | HER2 negative gastric cancer patients | Prognostic molecular markers; The sensitivity and specificity of ctDNA detection | 30 |
NCT02838836 | OBSERVATIONAL | Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients with Solid Cancers | Subjects with the diagnosis of a solid cancer of all stages will be included (lung, esophageal, stomach, bile duct/pancreas, colorectal, melanoma, sarcoma) | CTC/DTC numbers measured in blood, urine and bone marrow samples correlated with patient outcome | 120 |
NCT04576858 | OBSERVATIONAL | Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer | Patients with gastroesophageal cancer | Time to recurrence | 1950 |
NCT04385316 | OBSERVATIONAL | Clinical Study of Gastric Cancer, Colorectal Cancer and Bladder Cancer Based on Liquid Biopsy | Gastric cancer, colorectal cancer or bladder cancer patients in Jiangsu Provincial People’s Hospital | Tumor related mutation spectrum in different patients | 3 |
NCT03517332 | OBSERVATIONAL | Circulating Tumor DNA Exposure in Peripheral Blood | Subjects that are diagnosed with a malignancy (cohort 1); Subjects that have not been diagnosed with a malignancy (cohort 2) | test the feasibility of a novel process for the detection of circulating tumor DNA | 10,000 |
NCT02674373 | OBSERVATIONAL | Prognostic and Predictive Impact of Circulating Tumor DNA in Gastric Cancer Treatment | patients treated for a histologically proven, localized or advanced adenocarcinoma of gastric or gastro-oesophageal junction | PFS | 200 |
NCT05482516 | INTERVENTIONAL | Evaluating Novel Therapies in ctDNA Positive GI Cancers | Patients with GI Cancers | Rates of SignateraTM ctDNA positive Patient identification; Rate of ctDNA Complete Response (CR); Rate of ctDNA Partial Response (PR); Rate of ctDNA Progression of Disease (POD) or Clinical/radiographic Relapse | 20 |
NCT03957564 | INTERVENTIONAL | Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Gastric Cancer | Patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer (> T1 and N +) without distant metastases (M0) | Numbers and types of CTC pre- and post- neoadjuvant chemotherapy and after operation; Mutation rate and concentration of ctDNA pre- and post- neoadjuvant chemotherapy and after operation | 40 |
NCT04929015 | INTERVENTIONAL | Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study) | Patients with GI Cancers with documented diffuse peritoneal carcinomatosis | Clearance rate of ctDNA with cytoreductive surgery (CRS), comparing with clinical staging of CRS | 30 |
NCT04510285 | INTERVENTIONAL | A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2 + Esophagogastric Tumors with Persistent Circulating Tumor DNA Following Curative Resection | ECOG performance status 0–2 | Rate of ctDNA Clearance at 6 months with treatment | 1 |
NCT05594381 | INTERVENTIONAL | A Biomarker Study for Predicting the Efficacy of Neoadjuvant Sintilimab Plus SOX for Gastric Adenocarcinoma | G/GEJ adenocarcinoma patients with cStage III | Pathological complete response rate (pCR) | 90 |
NCT05494060 | INTERVENTIONAL | XELOX Combined with Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma | ECOG performance status score 0–1; Histologically or cytologically confirmed GC or GEJ carcinoma, had been treated with Radical resection (D2, R0 or R1); Pathological stage:II-III (8th AJCC TNM) | DFS | 80 |
NCT05348161 | INTERVENTIONAL | Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer | Patients histologically confirmed of unresectable recurrent or metastatic gastric adenocarcinoma with HER2 overexpression confirmed by IHC or ISH | Proportions and numbers of HER2 & PD-L1 positive CTC; Incidence rate of ctDNA deletion, amplification, insertion and other types of variation evaluated | 100 |
NCT04162665 | INTERVENTIONAL | MR-guided Pre-operative RT in Gastric Cancer | Newly diagnosed histologically or cytologically gastric adenocarcinoma | Complete pathologic response (pCR—primary and nodal) rate | 36 |