Table 5.
Ongoing Human Studies Investigating Exosomes as a Biomarker in Various Types of Cancer, as Registered in ClinicalTrials.gov
| ClinicalTrials.gov ID | Phase of Study | Cancer Type and Setting | Objectives | Outcome Measures |
|---|---|---|---|---|
| Lung Cancer | ||||
| NCT03542253 | Observational (Observ.) | Early lung cancer | Combined diagnosis of computerized tomography and exosome | Exosomal micro-A was highly expressed in early-stage lung cancer tissues |
| NCT02890849 | Prospect. cohort observ. | Non-small cell lung cancer | Consistency analysis of PD-L1 in cancer tissue and plasma exosome | Match rate of PD-L1 protein expression in cancer tissue and PD-L1 mRNA expression in exosome |
| NCT02921854 | Prospect. cohort observ. | Non-small cell lung cancer after radiotherapy and chemotherapy | Detection of circulating biomarkers of immunogenic cell death (ICD) | Research to see if exosomal markers of anti-tumor immunity can be detected in the serum |
| Breast Cancer | ||||
| NCT04288141 | Prospect. cohort observ. | HER2+ breast cancer on HER2 targeted therapies | Measure the expression of the HER2-HER3 dimer in the blood (exosomes) | Compare HER2 expression in blood exosomes by protein detection assays; correlate with change in HER2-HER3 dimer expression after HER2-directed therapy |
| NCT03974204 | Multicenter prospective single-arm observ. | Breast cancer patients suspected of leptomeningeal metastasis | Analyses of exosomes in the cerebrospinal fluid | Evaluate the use of proteomic profiles issued from cerebrospinal fluid exosomes |
| Gastrointestinal Cancer | ||||
| NCT01779583 | Prospect. case-control | Advanced gastric cancer on first-line chemotherapy | Circulating exosomes as potential prognostic and predictive biomarkers | Characterization of the molecular profile in cancer-derived exosomes |
| NCT03581435 | Prospect. case-control | Gallbladder carcinoma | Study of circulating exosome proteomics | Proteomics studies will be done in both tumor tissue and the circulating exosome |
| NCT03102268 | Prospect. cohort observ. | Cholangiocarcinoma patients without any anticancer therapy | Characterization of the noncoding RNAs in cancer-derived exosomes | Correlation of exosomes-derived ncRNAs and time-to-event end-points |
| NCT02393703 | Prospect. cohort observ. | Pancreatic cancer | Exosome-mediated intercellular signaling | Prospective cohort; exosomes purification for downstream proteomic and RNA sequencing |
| NCT03821909 | Prospect. cohort observ. | Patients suspected to have pancreatic masses undergoing diagnostic workup | Endoscopic ultrasound-guided portal venous blood sampling | Compare the expression of specific exosomal mRNA markers between portal venous and peripheral blood |
| NCT03874559 | Prospect. cohort observ. | Locally advanced rectal cancer on neoadjuvant chemoradiation | Characterize exosomal biomarker levels | Compare rates of exosomal expression before during and after chemoradiation therapy with pathological response rates |
| Genitourinary Tract Cancer | ||||
| NCT04053855 | Prospect. cohort observ. | Clear cell renal cell carcinoma post partial or total nephrectomy | Evaluation of urinary exosomes | Study CD9+ and CA9+ exosomes by electron microscopy technique |
| NCT04155359 | Prospect. cohort observ. | Urinary bladder cancer (UBC) in participants presenting with hematuria and another cohort of UBC patients | To establish the performance characteristics of a urine exosome-based diagnostic test to identify bladder cancer | Results compared to that of cystoscopy |
| NCT04357717 | Prospect. cohort observ. | Elevated PSA between 2 and 10 ng/mL and at least one prior negative prostate biopsy | Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort | Clinical Evaluation of ExoDx™ Prostate (IntelliScore) |
| NCT03911999 | Prospect. cohort observ. | Prostate cancer | Exosomal microRNA in predicting the aggressiveness of prostate cancer in Hong Kong Chinese patients | To compare the differences in miRNA expression |
| NCT03694483 | Prospect. case-control | Prostate cancer | Genetic analysis for the detection of prostasomes | Determine the sensitivity and specificity of the prostasome purification methodology |
| NCT02702856 | Prospective (Prospect.) cohort observ. | Prostate cancer (for first-time biopsy patients in the PSA Gray zone of 2.0–10 ng/mL) | Validation of a urinary exosome gene signature in men suspicious of prostate cancer | Correlate signature with the presence or absence of high-grade prostate cancer biopsy |
| NCT03236688 | Prospect. cohort observ. | Advanced metastatic castrate-resistant prostate cancer | Detection of ARv7 splice variant transcripts from exosomes in circulation | Correlate ARv7 status with PSA response and correlate non-Arv7 with clinical outcomes |
| NCT04167722 | Prospect. case-control | Prostate cancer status post robotic radical prostatectomy | Understanding the role of exosomal communication in lean vs obese patients | Collecting prostate and fat tissue from radical prostatectomy participants for culture |
| Sarcoma | ||||
| NCT03800121 | Prospect. cohort observ. | Soft tissue sarcoma | Study of exosomes in monitoring patients with sarcoma | To quantify circulating exosomes and analyze their protein and RNA content |
| NCT03108677 | Prospect. case-control | Primary High-Grade Osteosarcoma | Study if the profile of circulating exosomal RNA can be used as a biomarker for lung metastases | Differences in the levels and profiles of circulating exosome RNA from patients with or without lung metastasis |
| Hematological Cancer | ||||
| NCT03985696 | Prospect. cohort observ. | Aggressive non-Hodgkin B-cell lymphoma (B-NHL) | Evaluation of peripheral exosomes can be used as novel biomarkers in B-NHL | Evaluate if a high expression of CD20 and PD-L1 on exosomes may allow tumor cells to evade immunotherapy |
| Other Types of Cancer | ||||
| NCT02862470 | Prospect. cohort observ. | Newly diagnosed thyroid papillary, follicular and anaplastic thyroid cancer | Pilot prognostic study via urine exosomal biomarkers | Collect urine samples before an operation, immediately after surgery, postoperative 3, 6, and 12 months. |
| NCT02147418 | Prospect. case-control | Human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) | Exosome testing as a screening modality for HPV-positive OPSCC | To develop a new test that can detect specific HPV proteins in the blood or saliva to help improve detection of OPSCC |
| NCT03738319 | Prospect. case-control | High-grade serous ovarian carcinoma (HGSOC) | Analyze the expression of miRNA and lncRNA by next-generation sequencing | Candidate miRNA/lncRNA will be validated as a biomarker for the detection and prognosis of HGSOC |
| NCT03895216 | Prospect. cohort observ. | Cancer patients with bone metastases | To identify deregulated miRNAs within the circulating exosomes | Changes in miRNAs content of circulating tumor exosomes |