Table 4.
EV assay validation-review of clinical trials
| Study Title | Recruitment Status | Clinical Trial | Cancer type | Specimen Type | Target | Enrollment |
|---|---|---|---|---|---|---|
| Prostate Cancer | ||||||
| Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer | Completed | NCT02702856 | Prostate Cancer | Random, non-DRE, non catheter urine | Exosome RNA gene signature | 2000 |
| Clinical Evaluation of the ‘ExoDx Prostate IntelliScore’ in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics | Recruiting | NCT03031418 | Prostate Cancer | Urine | ExoDx Prostate Intelliscore | 1000 |
| A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy | Recruiting | NCT03235687 | Prostate Cancer | Urine | ExoDx Prostate Intelliscore | 1000 |
| Quantification and Purification of Circulating Prostasomes as Diagnostic Tool for Prostate Cancer Detection | Recruiting | NCT03694483 | Prostate Cancer | Plasma | Presence of prostasomes using the ExoPLA (Exosome in situ Proximity Ligation Assay) assay; prostasome miRNA sequencing. | 600 |
| Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP) | Recruiting | NCT03236688 | Metastatic Castrate Resistant Prostate Cancer | EDTA Plasma | ARv7 splice variant transcripts from exosomes | 30 |
| Pancreatic Cancer | ||||||
| Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC | Completed | NCT03032913 | Pancreatic cancer | Blood | GPC1+ exosomes | 52 |
| Phase IB/II Trial of High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have No Prior Therapy for Their Metastatic Pancreatic Cancer | Recruiting | NCT03410030 | Pancreatic Cancer | Blood | GPC1+ exosomes | 36 |
| Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma | Recruiting | NCT03334708 | Pancreatic Cancer | Blood | Not specified | 750 |
| Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer | Recruiting | NCT02393703 | Pancreatic Cancer | Blood and tissue | Exosome proteomics and RNA sequencing | 70 |
| A Pancreatic Cancer Screening Study in High Risk Individuals Including Those With New-Onset Diabetes Mellitus | Recruiting | NCT03250078 | Pancreatic cancer | Serum | Biobank | 800 |
| Lung Cancer | ||||||
| Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients | Recruiting | NCT03236675 | NSCLC | EDTA Plasma | EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in exosome | 60 |
| Detection of Circulating Biomarkers of Immunogenic Cell Death After Radiotherapy and Chemotherapy: An Exploratory Study | Recruiting | NCT02921854 | NSCLC | Blood | Not specified | 40 |
| Phase II, Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy of Olmutinib(Olita®) in Patients With NSCLC Who Harboring T790M Mutation Confirmed Using DNA Extracted From Extracellular Vesicles in Bronchoalveolar Lavage Fluid | Active, not recruiting | NCT03228277 | NSCLC | Bronchoalveolar Lavage Fluid | T790M mutation in EV | 25 |
| Combined Diagnosis of CT and Exosome in Early Lung Cancer | Not yet recruiting | NCT03542253 | Early Lung Cancer | cancer tissue and para cancerous tissue | Exosomal micor-A | 80 |
| Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome | Not yet recruiting | NCT02890849 | NSCLC | Plasma | PD-L1 mRNA in plasma exosomes (pExo) | 60 |
| Clinical Research for the Consistency Analysis of PD-L1 in Lung Cancer Tissue and Plasma Exosome Before and After Radiotherapy | Not yet recruiting | NCT02869685 | NSCLC | Plasma | PD-L1 mRNA in plasma exosomes (pExo) | 60 |
| Breast Cancer | ||||||
| A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Advanced Breast Cancer | Recruiting | NCT02514681 | HER2-positive Locally Advanced or Metastatic Breast Cancer | Blood | micro RNAs expression in EV | 370 |
| A Phase 2 Clinical Trial of the Combination of Pembrolizumab and Selective Androgen Receptor Modulator (SARM) GTX-024 in Patients With Metastatic Androgen Receptor (AR) Positive Triple Negative Breast Cancer (TNBC) | Recruiting | NCT02971761 | Breast Cancer | Blood | Temporal profile of tumor-derived exosomes | 29 |
| A Phase II Window of Opportunity Trial of Ipilimumab and Nivolumab in Metastatic Recurrent HER2- Inflammatory Breast Cancer (IBC) The Win Trial | Recruiting | NCT02892734 | Breast Cancer | Blood | ctDNA and Immune signature in exosome | 29 |
| A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy | Withdrawn | NCT01344109 | Breast cancer | Serum | protein surface markers and RNA profiles in tumor derived exosomes | 0 |
| Other Cancers | ||||||
| Pilot Study With the Aim to Quantify a Stress Protein in the Blood and in the Urine for Early Diagnosis of Malgnant Solid Tumors | Recruiting | NCT02662621 | Cancer | Blood and Urine | HSP-70 exosome | 80 |
| Pimo Study: Extracellular Vesicle-based Liquid Biopsy to Detect Hypoxia in Tumours | Recruiting | NCT03262311 | Cancer | Blood | Pimonidazole staining in EV | 20 |
| Phase I/II Clinical Trial of Daratumumab and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia Post-Allogeneic Hematopoietic Stem Cell Transplant | Not yet recruiting | NCT03537599 | Acute Myeloid Leukemia | bone marrow | Exosome number and content (protein, mRNA), and miRNAs | 30 |
| Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett’s Esophagus | Unknown | NCT02464930 | Barrett’s
Esophagus Gastroesophageal Reflux Esophageal Adenocarcinoma |
Serum and Bile | miRNA in exosome from serum and bile: miRNAs −192–5p, −215–5p and −194–5p | 220 |
| Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response | Active, not recruiting | NCT02439008 | Carcinoma, Hepatocellular Colorectal Neoplasms Melanoma Kidney Neoplasms |
Blood | Quantification of secreted exosomes | |
| Exosomes-derived ncRNAs As Biomarkers In Cholangiocarcinoma Patients | Recruiting | NCT03102268 | Cholangiocarcinoma | plasma | Exosome ncRNAs | 80 |
| A Phase 2, Single Arm, European Multi-center Trial Evaluating the Efficacy of Afatinib as First-line or Later-line Treatment in Advanced Chordoma | Recruiting | NCT03083678 | Chordoma | Blood | Circulating exosomes identification by PCR | 40 |
| Development of Novel Imaging and Laboratory Biomarkers to Monitor the Liver Pre-metastatic Niche and Guide Treatment of Colon Cancer: A Pilot Study | Recruiting | NCT03432806 | Colon Cancer | Blood | Exosomal protein | 80 |
| Circulating Exosomes As Potential Prognostic And Predictive Biomarkers In Advanced Gastric Cancer Patients: A Prospective Observational Study (“EXO-PPP Study”) | Unknown | NCT01779583 | Gastric Cancer | Serum | Plasma level and kinetics of gastric cancer derived exosomes | 80 |
| An Open-label Phase Ib, Study, to Determine Safety of Oral AL3810 in Patients With Locally Advanced or Metastatic Gastric, Hepatocellular or Nasopharyngeal Carcinoma | Not yet recruiting | NCT03260179 | Gastric, Hepatocellular or Nasopharyngeal Carcinoma | Plasma | Growth factor such as INFγ and cMyc in exosome | 60 |
| Newly diagnosed HGG: surgically eligible patients AdV-tk into wall of resection cavity; 1–3 days post-surgery Valacyclovir d1–14; Day 8 RT for 6 wks; day 15 TMZ 75mg/m2 daily; Nivo 240mgIV every 2 weeks | Active, not recruiting | NCT03576612 | Glioma, Malignant | Serum | Immune characterization of surface and content protein in EV | 36 |
| Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer | Recruiting | NCT03738319 | High Grade Serous Ovarian Cancer | Blood | Exosomal miRNA/lncRNA by next gen sequencing | 160 |
| A Pilot Study of Circulating Exosome RNA as Diagnostic and Prognostic Markers in Lung Metastases of Primary High-Grade Osteosarcoma | Recruiting | NCT03108677 | Lung Metastases Osteosarcoma |
Blood | Levels and mutations of circulating exosome RNA | 40 |
| Pilot Study of Exosomes Before and After BRAF Inhibitor Therapy in Patients With Advanced Unresectable or Metastatic BRAF Mutation-positive Melanoma | Unknown | NCT02310451 | Metastatic Melanoma | Blood | Not specified | 15 |
| An Observational, Single-Institution Pilot/Feasibility Study of Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma | Recruiting | NCT02147418 | Oropharyngeal Cancer | Primary cell culture and Oropharyngeal Rinse | Exosome Protein Signature | 30 |
| A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients | Recruiting | NCT03581435 | Proteinosis Gallbladder Carcinoma |
Blood | Exosome proteomics | 50 |
| A Prospective Study of Predicting Prognosis and Recurrence of Thyroid Cancer Via New Biomarkers, Urinary Exosomal Thyroglobulin and Galectin-3 | Recruiting | NCT03488134 | Thyroid Cancer | Urine | Galectin-3, Calprotectin A8, Calprotectin A9, TKT, Annexin II, Afamin, Keratin 8, Keratin 9, Angiopoietin-1 and TIMP in exosome | 150 |
| Anaplastic Thyroid Cancer and Follicular Thyroid Cancer-derived Exosomal Analysis Via Treatment of Lovastatin and Vildagliptin and Pilot Prognostic Study Via Urine Exosomal Biological Markers in Thyroid Cancer Patients | Active, not recruiting | NCT02862470 | Thyroid Cancer | Urine | Not specified | 22 |