Table 3.
ID | Name | Study type | Enrollment (Patients number) | Cancer type | Detection content | Clinical application | Endpoint |
---|---|---|---|---|---|---|---|
NCT03832569 [88] | Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors | Interventional | 10 | Colorectal cancer | ctDNA | Efficacy monitoring and relapse monitoring | Proportion of patients with ctDNA clearance and DFS. |
NCT03803553 [89] | Identification and Treatment of Micrometastatic Disease in Stage III Colon Cancer | Interventional | 500 | Colorectal cancer | ctDNA | Micrometastatic indentification and recurrence screening | DFS and clearance rate of ctDNA. |
NCT04457297 [90] | Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection (ALTAIR) | Interventional | 240 | Colorectal cancer | ctDNA | Selection of treatment | DFS |
NCT04576858 [91] | Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer (CURE) | Observational | 1950 | Esophageal cancer, Gastric cancer | ctDNA | Treatment effect evaluation, predictive and prognostic factors exploration | Time to recurrence. |
NCT04000425 [92] | Potential Clinical Utilities of Circulating Tumor DNA in Gastric Cancer | Observational | 55 | Gastric cancer | ctDNA | MRD monitoring or adjuvant chemotherapy response prediction | Description of disease recurrence risk according to first positive ctDNA detection. Description of ctDNA changing to adjuvant chemotherapy response. |
NCT04665687 [93] | Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients | Observational | 1730 | Gastric cancer | ctDNA, immunohistochemistry | Early detection and prognosis monitoring | Identify biomarkers for differential diagnosis and predicting recurrence between early gastric cancer and precancerous adenoma. |
NCT03588442 [94] | Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR) | Observational | 10,000 | Liver cancer | ctDNA | Early diagnosis and stratification of risk population | OS and liver-related disease progression. |
NCT02973204 [95] | Circulating Tumor Cells and Tumor DNA in HCC and NET | Observational | 167 | Liver cancer, Neuroendocrine Tumors | CTCs and cfDNA | Prognostic monitoring and individualized therapy | Through digital droplet PCR and targeted sequencing to explore concordance with specific DNA mutations found in patient biopsies and ctDNA. |
NCT04817046 [96] | Assessment of Early-detection Based on Liquid Biopsy in Lung Cancer (ASCEND-LUNG) | Observational | 467 | Lung cancer | cfDNA | Early detection | Accuracy of the multi-omics early-stage lung cancer diagnosis model. |
NCT03317080 [97] | Dynamic Monitoring Circulating Tumor DNA in Surgical Patients With Lung Cancer (LUNGCA) | Observational | 400 | Lung cancer | ctDNA | Cancer diagnosis, drug efficacy, surgical effect evaluation, recurrence monitoring, prognosis judgment, medication guidance, and molecular classification differentiation | Recurrence-free survival. |
NCT04790682 [98] | LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG (LIBERTYLUNG) | Interventional | 300 | Lung cancer | ctDNA | Immunotherapy treatment prediction | ctDNA variation of the prominent mutant allele variation |
NCT04822792 [99] | Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT (PRESCIENT) | Observational | 11,879 | Pan-cancer | Serum protein markers, cfDNA, blood RNA markers | Early-stage detection | Sensitivity and specificity of early detection of 22 types of cancers and TOO accuracy of a cfDNA methylation-based model, in combination with serum tumor markers. |
NCT04972201 [100] | A Proof of Concept Study of Pan-cancer Early Detection by Liquid Biopsy (PROMISE) | Observational | 2305 | Pan-cancer | cfDNA and miRNA | Early detection | Sensitivity of early detection of cancers and TOO accuracy of 3 assays of cfDNA mutation, cfDNA methylation and miRNA expression when specificity was 90%, 95% or 98% in healthy participants. |
ctDNA, circulating tumor DNA; DFS, disease-free survival; OS, overall survival; HCC, hepatocellular carcinoma; NET, neuro-endocrine tumor; cfDNA, cell free DNA; TOO, tissue of origin.