Table 1:
Exosome clinical application in cancer research
| No | Disease or Conditions | Interventions and Exosome source | Therapeutic and disease model | Clinical Trial Identification | Status & Clinical Phase |
|---|---|---|---|---|---|
| 1 | Metastasis (stage IV), melanoma (stage iiic) | Biological test blood | Exosome for developing theranostic tools | NCT02310451 | Unknown & Not applicable |
| 2 | Pancreatic cancer | Endoscopic ultrasound-guided portal venous blood sampling exosome | Feasibility and safety of sampling portal venous blood, detecting CTCs, and analyzing mRNA markers | NCT03821909 | Recruiting & Not applicable |
| 3 | Colon cancer | Curcumin, Curcumin conjugated with plant exosome. | Exosome loaded curcumin on the immune modulation, cellular metabolism, and phospholipid profile of normal vs. Malignant | NCT01294072 | Active, not recruiting, Phase 1 |
| 4 | Early lung cancer | CT chest scans and blood, exosome detection | We are using peripheral blood exosomes in identifying early biomarkers for lung cancer. | NCT03542253 | Not yet recruiting & Not applicable |
| 5 | Sarcoma | Blood samples | Evaluate cancer pathogenesis, progression, and treatment efficiency of the serum-derived exosomes. | NCT03800121 | Recruiting & not applicable |
| 6 | Prostate cancer | Urine exosomes | Validate a non-DRE exosome gene expression test of prostate cancer in a prostate needle biopsy | NCT02702856 | Completed & not applicable |
| 7 | Pancreatic cancer, Benign pancreatic disease | Blood sample from patients and healthy controls | Exosome purification for such as proteomics and RNA sequencing. | NCT02393703 | Active, not recruiting & not applicable |
| 8 | Clear cell renal cell carcinoma | Urine samples | Detecting tumor exosomes in urine, a new biopsy tool for early diagnosis | NCT04053855 | Not yet recruiting & |
| 9 | Lung metastases osteosarcom a | Blood sample | Identifying the levels and mutations of circulating exosomal RNA with or without lung metastasis. | NCT03108677 | Recruiting & Not applicable |
| 10 | Proteinosis gallbladder carcinoma | Exosomes from blood specimens | Correlations between exosome biomarkers and gallbladder carcinoma. | NCT03581435 | Recruiting & Not applicable |
| 11 | Metastatic & ductal (stage IV) Pancreatic adenocarcin oma, Pancreatic cancer AJCC v8 | Mesenchymal stromal cells-derived exosomes with KRAS G12D siRNA | Mesenchymal stromal cells-derived exosomes with krasg12d siRNA (exosomes) in treating participants with pancreatic cancer with krasg12d mutation | NCT03608631 | Not yet recruiting & Phase 1 |
| 12 | Breast neoplasms | Tumor-derived exosomes | Evaluating the use of tumor-derived exosomes as a marker for response to therapy in women receiving neoadjuvant chemotherapy | NCT01344109 | Withdrawn & Not applicable |
| 13 | Cholangiocar cinoma benign biliary stricture | Cholangiocarcino ma derived exosomes | Characterize the ncRNAs of cholangiocarcinoma obtained exosomes as a diagnostic tool and evaluate the prognostic and predictive value of cholangiocarcinoma exosome levels in plasma, before and after surgical resection. | NCT03102268 | Recruiting & Not applicable |
| 14 | Pancreatic ductal adenocarcin oma (PDAC) | The portal vein blood sample | Test 3 CTC isolation methods and analyses by flow cytometry for onco-exosomes in pancreatic cell lines’ culture media. | NCT03032913 | Completed & Not applicable |
| 15 | Sleep apnea syndromes, obstructive cancer | Blood samples | To evaluates exosomal PD-1/PD-L1 expression in patients | NCT03811600 | Not yet recruiting & Not applicable |
| 16 | Gastric cancer | Gastric cancer-derived exosomes | Characterize gastric cancer-derived exosomes’ molecular profile as diagnostic tools and evaluate gastric cancer exosomes levels in plasma prognostic and predictive value. | NCT01779583 | Unknown & Not applicable |
| 17 | Bone metastases | Circulating tumor exosome | Identify deregulated miRNAs, subsequent bioinformatics analysis to identify their potential role in tumor progression | NCT03895216 | Recruiting & Not applicable |
| 18 | Oropharyngeal cancer | Exosomes from blood and saliva | Detect specific HPV proteins in the blood or saliva exosomes to help improve the detection of OPSCC. | NCT02147418 | Recruiting & Not applicable |
| 19 | Larynx, lip, oral cavity, pharynx | Metformin Hydrochloride, Placebo, Cancer exosomes. | Identify the role of metformin hydrochloride and exosomes in cancer cells’ metabolic activity and surrounding supportive tissues. | NCT03109873 | Active, not recruiting & Early Phase 1 |
| 20 | Carcinoma ovarian cancer, benign gynecologic diseases | Ovarian cancer exosomes, | Analyze the expression of micro-RNA and long non-coding RNA of exosomes by next-generation sequencing | NCT03738319 | Recruiting & Not applicable |
| 21 | Oral mucositis, head, and neck cancer, | Grape extract exosomes, Drug: Lortab, Fentanyl patch, mouthwash | The ability of plant (grape) exosomes to prevent oral mucositis of head and neck cancer. | NCT01668849 | Active, Not recruiting & Phase 1 |
| 22 | Non-small cell lung cancer (NSCLC) | Plasma exosome, liquid biopsy | Plasma exosome, new radiotherapy combining with immunotherapy. | NCT02890849 | Unknown & Not applicable |
| 23 | Non-small cell lung cancer (NSCLC) | Plasma exosomes radiotherapy | plasma exosome level before and after radiotherapy, PD-L1 mRNA levels in Pexo, and radiotherapy practice combined with immunotherapy. | NCT02869685 | Unknown & Not applicable |
| 24 | Non-small cell lung cancer | Dendritic cell-derived exosome | Phase I trials showed no induction of T cells could be monitored in patients. | NCT01159288 | Completed & Phase 2 |
| 25 | Rectal cancer | Blood sample from participants, Neoadjuvant chemoradiation therapy | Characterize exosomal biomarker levels in patients and compare exosomal expression rates before, during, and after chemoradiation therapy. | NCT03874559 | Recruiting & Not applicable |
| 26 | Breast cancer leptomening eal metastasis | CSF and blood | Use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases. | NCT03974204 | Not yet recruiting & Not applicable |
| 27 | Metastatic castrate resistant prostate cancer, | Blood samples, Abiraterone and Enzalutamide | Detection of arv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre-and post-treatment with selective Androgen pathway inhibitors. | NCT03236688 | Active, not recruiting & Not applicable |
| 28 | Bladder cancer | Urine samples | Urine samples analysis compared to the results of cystoscopy. | NCT04155359 | Not yet recruiting |
| 29 | Lung cancer (diagnosis) | Exosomes from plasma, human bronchial epithelium & cancer cells | Serum exosomes noncoding RNA as a biomarker’s sensitivity and specificity for the determination of lung cancer | NCT03830619 | Recruiting & Not applicable |
| 30 | Carcinoma, non-small-cell lung | Blood samples | Feasibility identifying EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in NSCLS patients’ circulation. | NCT03236675 | Active, not recruiting & Not applicable |
| 31 | Cancer | Blood and urine | HSP70-exosome can be used for the early diagnosis of patients with a solid malignant tumor. | NCT02662621 | Recruiting & Not applicable |
| 32 | Thyroid cancer | Urine sample, Urine exosomal thyroglobulin and galectin-3 | Identifying urinary exosomal proteins, including thyroglobulin and galectin 3 | NCT03488134 | Active, not recruiting & Not applicable |
| 33 | New tumor diagnostics from human plasma samples | Plasma samples | Protein profiling on the isolated exosomes and isolate nucleic acids from exosomes for analysis. | NCT04081194 | Recruiting & Not applicable |
| 34 | Prostate cancer | Genetic analysis for the detection of prostasomes | Purification of prostasomes from prostate cancer patients and their ability to determine the grade of the prostate tumors. | NCT03694483 | Recruiting & Not applicable |
| 35 | Prostate cancer | Exodx Prostate Intelliscore, Urine samples | Investigating a new and validated urine test that predicts the likelihood of high-grade prostate cancer on an initial prostate biopsy | NCT03031418 | Recruiting & Not applicable |
| 36 | Colon cancer, Liver tumors | Blood draws, colectomy or hepatectomy, fibroscan test | Novel ways of diagnosing colon cancer and predicting its propensity to spread to other organs such as the liver. | NCT03432806 | Recruiting & Not applicable |
| 37 | Prostate cancer | Exodx prostate (intelliscore), urine samples | Validated urine test to predicts the likelihood of high-grade prostate cancer on an initial prostate biopsy. | NCT03235687 | Active, not recruiting & Not applicable |
| 38 | Pancreatic carcinoma &intraductal papillary mucinous neoplasm | Optical Coherence tomography, blood samples | How well ultra-high-resolution optical coherence tomography works to detect micrometer-sized early-stage pancreatic cancer in participants with pancreatic cancer. | NCT03711890 | Not yet recruiting & Not applicable |
| 39 | Prostatic neoplasms | Drug: 18F- dcfpyl PET/CT, | Identify the sensitivity and specificity of 18F-dcfpyl PET/CT, basis, and characterize ctdna and exosome. | NCT03824275 | Recruiting & Phase 2, Phase 3 |
| 40 | Prostate Cancer | Urine and serum exosomes | Investigate the relationship between urinary exosome and the aggressiveness of prostate cancer. | NCT03911999 | Recruiting & Not recruiting |
| 41 | Triple-negative breast cancer | Merck 3475 Pembrolizumab, intraoperative radiation therapy (IORT), serum exosomes | Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating lymphocytes, and serum exosomes | NCT02977468 | Recruiting & Phase 1 |
| 42 | Renal fibrosis, Kidney transplant failure | Kidney transplantation urine exosomes | Urinary exosomes and the degree of graft fibrosis to determine biomarkers | NCT03870542 | Recruiting & Not applicable |
| 43 | No small lung cancer | Blood and serum sample, high-dose radiotherapy, cisplatin-doublet therapy, and radiotherapy | Markers (molecular and immunological) of ICD or anti-tumor immunity (exosomal or molecular) can be detected in the serum | NCT02921854 | Completed & not applicable |
| 44 | Thyroid cancer | Urine exosome protein biomarker | Evaluate new therapeutic mechanism and medications for poorly differentiated or anaplastic thyroid cancer. | NCT02862470 | Active, not recruiting & Not applicable |
| 45 | Oncology | Interstitial tissue fluid of pancreatic cancer site | A short OMICS analysis of PDAC (all stages confounded) uses a "modified EXPEL" procedure. | NCT03791073 | Recruiting & Not applicable |
| 46 | Lymphoma, T-Cell | MK-3475, Copanlisib, Blood samples, peripheral blood lymphocytes PD-1 expression, peripheral blood T-cell and NK-cell | PD-1 and PD-L1 expression on tumor tissue; tumor-infiltrating lymphocytes and gene expression as prognostic and predictive biomarkers. | NCT02535247 | Recruiting & Phase 1, Phase 2 |
| 47 | Ovarian cancer ovarian neoplasms | Blood samples | To see if monocytes taken from the blood of people with ovarian cancer can kill tumor cells. | NCT02063464 | Completed & Not applicable |
| 48 | Lung cancer | Blood samples | Diagnosis stages I-IV lung cancer drug efficacy, surgical effect evaluation, recurrence monitoring, prognosis judgment, medication guidance, and molecular classification differentiation via analyzing blood ctDNA. | NCT03317080 | Recruiting & Not applicable |
| 49 | Carcinoma, Hepatocellular, kidney and Colorectal neoplasms,melanoma, | Blood samples collected before, after, and during radiotherapy, Blood sample exosome | This study will follow-up immune cell populations secreted factors and released nanovesicles in the blood back, during, and after high dose radiation therapy. | NCT02439008 | Terminated & Not applicable |
| 50 | Thyroid cancer | Metformin, hydrochloride, radioactive Iodine, placebo, saliva, and serum samples | Metformin hydrochloride works against radioactive iodine treatment of differentiated thyroid cancer. | NCT03109847 | Recruiting & Phase 2 |
| 51 | Prostate cancer | Whole-body MRI, blood exosomes | Compare diagnostic concordance of whole body multi‐parametric Magnetic Resonance Imaging (MRI) with current conventional multi-modality reference standard imaging | NCT02935816 | Unknown & Not applicable |
| 52 | Pancreatic neoplasms | Diagnostic Test: MRI/MRCP, serum, and blood | MRI/MRCP to screen for early stage pancreatic cancer or precursor lesions by analyzing blood samples from pancreatic cancer | NCT03250078 | Recruiting & Not applicable |
| 53 | Prostate cancer | Urine sample | Validate the performance characteristics of the mir Scientific Sentinel™ CS test and mir Scientific Sentinel™ PCA test. | NCT04100811 | Not yet recruiting & Not applicable |
| 54 | Pancreatic cancer, Pancreatic diseases, Pancreatitis | Blood draw, cyst fluid, tumor tissue collection, functional DNA repair assays | Blood samples were analyzed for various biomarkers. First biomarkers like proteins and proteases, exosomes, stromal elements, circular RNAs, and circulating tumor DNA | NCT03334708 | Recruiting & Not applicable |
| 55 | Lip, oral cavity squamous pharynx, larynx, squamous arcinoma | Nivolumab, IDO1 Inhibitor BMS986205, therapeutic conventional surgery | Change in exosome composition and abundance in the peripheral blood | NCT03854032 | Recruiting & Phase 2 |
| 56 | Metastatic colorectal cancer | Toripalimab, stereotactic body radiotherapy | Use of stereotactic body radiation therapy in combination with ICI in colorectal cancer patients with oligometastatic | NCT03927898 | Recruiting & Phase 2 |
| 57 | Soft tissue sarcoma | MDM2, AMG-232, radiation therapy | Side effects of MDM2 inhibitor AMG-232 and radiation therapy in treating patients with soft tissue sarcoma. | NCT03217266 | Recruiting & Phase 1 |
| 58 | Non-small cell lung cancer | Olmutinib | Evaluate the efficacy of Olmutinib (Olita®) in patients with T790M-positive non-small cell lung cancer confirmed using DNA extracted from the exosomes in bronchoalveolar lavage fluid. | NCT03228277 | Completed & Phase 2 |
| 59 | Recurrent inflammatory breast carcinoma, HER2/neu negative, stage IV breast cancer, stage IV | Ipilimumab, laboratory biomarker analysis, Nivolumab | ctDNA and immune signature assessed by exosome analysis in blood samples. | NCT02892734 | Terminated Has result & Phase 2 |
| 60 | Renal cell cancer | Urine and serum samples | Metastatic renal cell cancer (RCC) treatment uses five kinase inhibitors sunitinib, everolimus, temsirolimus, sorafenib, and pazopanib, which are now approved for clinical application. | NCT02071719 | Terminated & Not applicable |
| 61 | Advanced solid tumor, Advanced/m etastatic colorectal cancer | Drug: AL3810 | Study of personalized medicine evaluation system establishment for liver cancer, gastric cancer, and nasopharynx cancer. | NCT03260179 | Phase 1 |
| 62 | Prostate cancer | Drug: steroids switch, Blood samples exosomes | The change of prednisone to dexamethasone in CRPC patients that progress biochemically to AA + prednisone can improve. | NCT02928432 | Completed & Phase 2 |
| 63 | Recurrent lung non-small cell carcinoma, stage II, IIA, IIB, IIIA & IIIB Cancer AJCC v7 | Image-guided radiation therapy, intensity-modulated radiation therapy, laboratory biomarker analysis | Radiation dose is delivered on the body, pass into the tumor, and through the body. | NCT01629498 | Recruiting & Phase 1, Phase 2 |
| 64 | Prostate cancer | Samples with DNA, human tissue, body fluids, and fresh blood tissue | This study is to collect healthy and cancerous tissues. | NCT00578240 | Active, not recruiting & Not applicable |
| 65 | Metastatic triple-negative breast carcinoma, stage IV breast cancer AJCC v6 and v7 | Enobosarm, laboratory biomarker analysis, Pembrolizumab | Giving pembrolizumab and enobosarm may work better than pembrolizumab alone in treating androgen receptor-positive triple-negative breast cancer. | NCT02971761 | Active, not recruiting & Phase 2 |
| 66 | Tumors refractory solid tumors, cancer, neoplasms, recurrent solid tumors | IT-141 | Deliver more drugs via exosomes to the tumor with reduced toxicity on healthy tissues. | NCT03096340 | Recruiting & Phase 1 |
| 67 | Pancreatic cancer, pancreatic resectable & pancreatic ductal adenocarcin oma. | Ascorbic acid, paclitaxel protein-bound, cisplatin, gemcitabine | Combination of paclitaxel protein-bound (also known as nab-paclitaxel), gemcitabine, and cisplatin, effective in individuals with untreated metastatic pancreatic cancer. | NCT03410030 | Recruiting & Phase 1, Phase 2 |
| 68 | Prostate cancer, obesity | Robotic radical prostatectomy | How fat cells communicate with prostate cancer cells to look at how exosomes communication. | NCT04167722 | Recruiting & Not applicable |
| 69 | Recessive dystrophic epidermolysi s bullosa | Drug: Rigosertib Sodium Other: Quality-of-life assessment | How rigosertib sodium works in treating patients with recessive dystrophic epidermolysis bullosa (RDEB) with locally advanced squamous cell carcinoma. | NCT04177498 | Not yet recruiting & Early Phase 1 |
| 700 | Rectal neoplasm, malignant Carcinoma, adenocarcin oma | Radiation, capecitabine-Irinotecan combination, plasma exosome | Research on Biomarkers for Predicting the efficacy and toxicities of Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer Based on Tissue and Plasma Exosomal RNA | NCT04227886 | Recruiting & Not applicable |
| 71 | HER2-positive breast cancer | Acquisition of blood samples and tumor tissue samples (biopsies) | Blood tests for anti-HER2 treatments, instead of invasive tissue biopsies | NCT04288141 | Recruiting & Not applicable |
| 72 | Lung cancer | Blood exosome | Molecular and cellular biomarkers (exosomes antigens, circulating tumor cells -, the panel of mutations in circulating free DNA), and radiomic signature are complementary to assist early detection of lung cancer LDCT. | NCT04315753 | Recruiting & Not applicable |
| 73 | Prostate cancer obesity | Exosome from biological samples | The investigators will be collecting prostate and fat tissue from participants undergoing radical prostatectomy to culture and study in the laboratory. | NCT04167722 | Recruiting & Not applicable |
| 74 | Metastasis breast cancer genomic analysis | Tissue and Blood samples | Metastatic breast cancer with genetic tests including WES, RNAseq, ctDNA, and exosomes | NCT04258735 | Recruiting & not applicable |
| 75 | Prostate cancer | Liquid biopsies sample | Correlation of the exodx Prostate test results with the outcome of prostate biopsies. | NCT04357717 | Recruiting & Not applicable |
| 76 | Lung cancer | Exosome antigen analysis | Molecular and cellular biomarkers (exosomes, protein signatures, circulating tumor cells - CTCs, microRNA) | NCT04323579 | Recruiting & Not applicable |
| 77 | Cancer | Distress exosome from patients | Benefits of these psychological interventions on changes in exosomes | NCT04298398 | Not yet recruiting & Not applicable |
| 78 | Prostate cancer | Urine and semen biomarkers | Perform urinary and seminal genome, exosomes, methylome, and transcriptome analysis to identify novel molecular signatures associated with prostate cancer imaging endotypes | NCT04340245 | Not yet recruiting & Not applicable |
| 79 | Colorectal cancer | Blood sample exosomes | Exosome protein marker for the diagnostic tool | NCT04394572 | Not yet recruited & Not applicable |
| 80 | Lung cancer | Blood and serum sample | The exosome is a liquid biopsies diagnosis tool for lung cancer | NCT04529915 | Active, not recruiting |
| 81 | Untreated advanced NSCLC patients | Plasma exosomes | Performance of exosomes loaded with EML4-ALK fusion in NSCLC diagnosis. | NCT04499794 | Recruiting, |
| 82 | Squamous cell carcinoma of the head and neck | Serum, cell fluid exosomes | Use of the hemopurifier to clear immunosuppressive exosomes in combination with pembrolizumab (Keytruda) | NCT04453046 | Recruiting, not applicable |
| 83 | NSCLC patients | Plasma exosomes, pabolizumab, nafulizumab. | Plasma exosomes PD-L1 and mRNA as a biomarker after therapeutic efficacy against NSCLC. | NCT04427475 | Recruiting, not applicable |
| 84 | Lung cancer | Blood exosomes | Blood exosomes analysis to determine hypoxia as a potential biomarkers for early detection. | NCT04629079 | Recruiting, not applicable |
| 85 | Breast, digestive, gynecologic cancer circulating, tumor DNA, exosomes | Blood samples | Blood exosome as an early biomarkers for digestive and gynecological/ breast cancer. | NCT04530890 | Not yet recruiting and not applicable |
| 86 | Prostate cancer | Blood sample | Blood exosome biomarker for early detection. | NCT04556916 | Not yet recruiting and not applicable |
| 87 | Pancreas adenocarcin oma | Venous sampling | Tumor cells secret exosome and long RNA, small RNA, miRNA, tRNA, piRNA analysis as a biomarker. | NCT03711890 | Recruiting and not applicable |