Table 2.
Summary of clinical trials using extracellular vesiclesa.
| Vesicle type | Cancer type | Trial phase | Trial aim|(s) | Trial status | Application | Trial number |
|---|---|---|---|---|---|---|
| PART I: EXOSOMES | ||||||
| Plant exosome | Colon cancer | I | Investigating the ability of plant exosomes to deliver curcumin to normal & colon cancer tissue. | Active, not recruiting | Drug delivery | NCT01294072 |
| Urinary exosome | Prostate cancer | – | Clinical validation of a urinary exosome gene signature in men presenting for suspicion of prostate cancer. | Completed | Biomarker | NCT02702856 |
| Exosome | Malignant solid tumors | – | Quantify a stress protein in the blood and in the urine for the monitoring and early diagnosis of malignant solid tumors. | Recruiting | Diagnostic | NCT02662621 |
| Exosome | Esophageal adenocarcinoma | – | Evaluation of MicroRNA expression in blood and cytology for detecting Barrett's esophagus & associated neoplasia. | Recruiting | Diagnostic | NCT02464930 |
| Exosome | Ovarian cancer | – | To see if monocytes taken from the blood of people with ovarian cancer can kill tumor cells (exosomes, may influence outcome). | Completed | Mechanistic | NCT02063464 |
| Urine exosome | Thyroid cancer | – | Anaplastic thyroid cancer & follicular thyroid cancer-derived exosomal analysis via treatment of lovastatin and vildagliptin & pilot prognostic study via urine exosomal. | Not yet recruiting | Biomarker | NCT02862470 |
| Onco-exosomes | Pancreatic cancer | – | Diagnostic accuracy of circulating Tumor cells (CTCs) and onco-exosome quantification in the diagnosis of pancreatic cancer. | Recruiting | Diagnostic | NCT03032913 |
| Exosome | Exosome | – | Circulating exosomes as potential prognostic and predictive biomarkers in advanced gastric cancer patients: A prospective observational study. | Unknown | Biomarker | NCT01779583 |
| Exosome | Cholangiocarcinoma | – | Characterization of the ncRNAs in tumor derived exosomes from cholangiocarcinoma patients before anti-cancer therapies & benign biliary stricture patients. | Recruiting | Recruiting | NCT03102268 |
| Exosome | Oropharyngeal squamous cell carcinoma | – | Exosome testing as a screening modality for human papillomavirus-positive oropharyngeal squamous cell carcinoma. | Recruiting | Screening biomarker |
NCT02147418 |
| Plant exosome | Head and neck cancer | – | Evaluation of the ability of edible plant exosome to prevent oral mucositis associated with chemo radiation treatment of head & neck cancer. | Recruiting | Drug delivery | NCT01668849 |
| Exosome | Head and neck cancer | I | Studies how well metformin affects cytokines & exosomes in patients with head & neck cancer. |
Recruiting | Drug effect | NCT03109873 |
| Exosome | Non-small cell lung cancer | – | Consistency analysis of PD-L1 in cancer tissue & plasma. | Not yet recruiting | Diagnostic | NCT02890849 |
| Exosome | Non-small cell lung cancer | – | Consistency analysis of PD-L1 in cancer tissue & plasma exosome. | Not yet recruiting | Diagnostic | NCT02869685 |
| DC-derived exosomes | Non-small cell lung cancer | II | Consistency analysis of PD-L1 in lung cancer tissue and plasma exosome before & after radiotherapy. | Unknown | Vaccine | NCT01159288 |
| Exosome | Metastatic melanoma | – | Study of molecular mechanisms implicated in the pathogenesis of melanoma. Role of exosomes. | Recruiting | Mechanistic | NCT02310451 |
| Exosome | Lung metastases osteosarcoma | – | Whether the profile of RNA from circulating exosomes can be used as a biomarker for lung metastases of primary high-grade osteosarcoma. | Recruiting | Biomarker | NCT03108677 |
| Exosome | Pancreatic cancer | – | Interrogation of exosome-mediated intercellular signaling in patients with pancreatic cancer. | Recruiting | Mechanistic | NCT02393703 |
| PART II: MICROPARTICLES | ||||||
| Microparticles | Breast cancer | II | Assess the reduction of tissue factor bearing microparticles in metastatic breast cancer treated with rosuvastatin. | Active, not recruiting |
Treatment | NCT01299038 |
| Microparticles | Advanced pancreatic, colon, lung, gastric and ovarian | The cumulative incidence of VTE at 2 months in the higher venous thrombo-embolic events in cancer patients with high levels of circulating tissue factor bearing microparticles (TFMP). | Completed | Diagnostic | NCT00908960 | |
| Microparticles | Deep vein thrombosis (DVT) and cancer | Determine the prevalence of asymptomatic lower extremity DVT detected by US-doppler and pro-coagulant microparticles in a selected group of cancer patients suffering from an advanced stage of the disease. | Completed | Diagnostic | NCT00336258 | |
| Microparticles | Myeloproliferative neoplasm (MPN) | Platelet microparticles are involved in the hypercoagulability of MPNs patients. | Completed | Mechanistic | NCT02862366 | |
| Microparticles | Cancer, deep venous thrombosis, pulmonary embolism | To identify cancer patients at high risk for VTE based on clinical characteristics, coagulation biomarkers & the coagulant activity of tissue factor bearing microparticles. | Completed | Biomarker | NCT02095925 | |
| Microparticles | Malignant pleural effusion | II | To investigate the anticancer effect and the related immunological mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in the treatment of malignant pleural effusion. | Recruiting | Drug delivery | NCT02657460 |
| Microparticles | Venous thromboembolism, pulmonary thromboembolisms, cancer | Carrying out a study in cancer-associated-thromboembolism patients in order to decide the suitable anticoagulation time. Pro-coagulant role of phospholipid-dependent microparticles. | Completed | Diagnostic | NCT03134820 | |
| Tumor-derived microparticles | Malignant pleural effusion, malignant ascites | II | Safety and effectiveness study of tumor cell-derived microparticles to treat malignant ascites and pleural effusion. | Unknown | Treatment | NCT01854866 |
| Microparticles | Colon cancer | – | Examining the relationship between relaxation combined with biofeedback or wheat germ juice to the immune indices and quality of life measures in patients with colorectal cancer who receive prophylactic chemotherapy after surgery. | Recruiting | Mechanistic | NCT01991080 |
| Tumor-derived microparticles | Pancreatic cancer | III | Safety and efficacy of clopidogrel in loc-ally advanced & metastatic pancreatic adenocarcinoma treated with chemotherapy. | Recruiting | Drug safety & efficacy |
NCT02404363 |
| Microparticles | Hepatic, pancreatic and colorectal neoplasms | – | To investigate quantitative and qualitative aspects of microparticles during cardiac and abdominal operations. | Completed | NCT00677781 | |
| Microparticles | Acute lymphoblastic leukemia | – | Role of the microparticles and of tissue factor in the pro-thrombotic phenotype and the thromboembolic complications during the acute lymphoblastic leukemia in children. | Completed | Diagnostic | NCT02862652 |
| Microparticles | Prostate cancer | Evaluation of a novel circulating microvesicle-based multi-analyte assay for the detection of prostate cancer in men with elevated risk for prostate cancer. | Completed | Diagnostic | NT01499381 | |
a
Retrieved from https:clinicaltrials.gov/ct2/search as on 17/10/2018.