Saliva and Plasma Exosomes for Oral Leukoplakia Malignant Transformation Diagnosis and Oral Cancer Prognosis Monitoring
NCT ID: NCT06469892
Last Updated: 2024-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
225 participants
OBSERVATIONAL
2020-06-13
2023-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Is it possible to identify the cancer risk of oral leukoplakia in its early stages by detecting salivary and plasma exosomal miR-185?
* Is it possible to monitor the cancer risk of oral leukoplakia and the prognosis of oral cancer using salivary exosomal miR-185?
Participants will be asked to:
* Cooperate with the investigators in completing the oral examination.
* Take saliva and plasma before the biopsy surgery.
* Perform the biopsy surgery following the usual diagnostic procedures.
* Attend regular follow-up appointments (every 3 months) for the duration of the study.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Senstivity and Specificity of Using Salivary miRNAs in Detection of Malignant Transformation of Oral Lesions.
NCT04913545
Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
NCT05730855
The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw
NCT03418454
In Vivo Confocal Imaging of Oral Mucosa
NCT00502125
Infectious Aetiology of Potentially Malignant Disorders and Squamous Cell Carcinomas of the Oral Cavity
NCT01636544
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
OTHER
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Detect the expression level of miR-185 in salivary and plasma exosomes.
Participants were instructed to refrain from eating, drinking, brushing their teeth, rinsing their mouth, or taking medications for one hour before saliva collection. They were then asked to bend over, lower their head, open their mouth, and allow saliva to flow naturally without chewing or spitting. Using a specialized container, 2 mL of unstimulated saliva was collected.
Participants fasted overnight before blood collection. Researchers used plasma tubes containing anticoagulant (EDTA) to obtain venous blood (4-5 mL) from the participants\' upper arm. Subsequently, the blood was gently inverted to ensure optimal contact with the anticoagulant before centrifugation at 2000 rpm and 4°C for 10 minutes. Following centrifugation, the supernatant was extracted.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical diagnosis consistent with oral leukoplakia and oral cancer.
* Individuals with local stimulating factors correlated with oral lesions (including residual roots, residual crowns, poor oral restorations, cheek biting, and tongue biting habits).
* Oral lesions not subjected to any treatment, including laser, photodynamic therapy, radiotherapy, and chemotherapy.
Exclusion Criteria
* Females who were pregnant or breastfeeding.
* Individuals who had malignancy, severe and precariously controlled diabetes mellitus, episodes of cardiovascular disease, hepatic or renal dysfunction, respiratory disease, hematologic disease, or immune abnormalities in the past year.
* Individuals with a psychiatric disorder.
* Other conditions deemed inappropriate for study participation by the researchers.
30 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Stomatological Hospital, Capital Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaobing Guan
Doctor and Professor of Oral Medicine，and Director of Department of Oral Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaobing Guan, Ph.D.
Role: STUDY_DIRECTOR
Beijing Stomatological Hospital, Capital Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Stomatological Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jing R, Chen W, Wang H, Ju S, Cong H, Sun B, Jin Q, Chu S, Xu L, Cui M. Plasma miR-185 is decreased in patients with esophageal squamous cell carcinoma and might suppress tumor migration and invasion by targeting RAGE. Am J Physiol Gastrointest Liver Physiol. 2015 Nov 1;309(9):G719-29. doi: 10.1152/ajpgi.00078.2015. Epub 2015 Aug 27.
Liu J, Han Y, Liu X, Wei S. Serum miR-185 Is a Diagnostic and Prognostic Biomarker for Non-Small Cell Lung Cancer. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820973276. doi: 10.1177/1533033820973276.
Zhang W, Sun Z, Su L, Wang F, Jiang Y, Yu D, Zhang F, Sun Z, Liang W. miRNA-185 serves as a prognostic factor and suppresses migration and invasion through Wnt1 in colon cancer. Eur J Pharmacol. 2018 Apr 15;825:75-84. doi: 10.1016/j.ejphar.2018.02.019. Epub 2018 Feb 15.
Zhong WQ, Ren JG, Xiong XP, Man QW, Zhang W, Gao L, Li C, Liu B, Sun ZJ, Jia J, Zhang WF, Zhao YF, Chen G. Increased salivary microvesicles are associated with the prognosis of patients with oral squamous cell carcinoma. J Cell Mol Med. 2019 Jun;23(6):4054-4062. doi: 10.1111/jcmm.14291. Epub 2019 Mar 25.
Nieuwland R, Siljander PR. A beginner's guide to study extracellular vesicles in human blood plasma and serum. J Extracell Vesicles. 2024 Jan;13(1):e12400. doi: 10.1002/jev2.12400.
Witwer KW, Buzas EI, Bemis LT, Bora A, Lasser C, Lotvall J, Nolte-'t Hoen EN, Piper MG, Sivaraman S, Skog J, Thery C, Wauben MH, Hochberg F. Standardization of sample collection, isolation and analysis methods in extracellular vesicle research. J Extracell Vesicles. 2013 May 27;2. doi: 10.3402/jev.v2i0.20360. eCollection 2013.
Coumans FAW, Brisson AR, Buzas EI, Dignat-George F, Drees EEE, El-Andaloussi S, Emanueli C, Gasecka A, Hendrix A, Hill AF, Lacroix R, Lee Y, van Leeuwen TG, Mackman N, Mager I, Nolan JP, van der Pol E, Pegtel DM, Sahoo S, Siljander PRM, Sturk G, de Wever O, Nieuwland R. Methodological Guidelines to Study Extracellular Vesicles. Circ Res. 2017 May 12;120(10):1632-1648. doi: 10.1161/CIRCRESAHA.117.309417.
Vasconcelos MH, Caires HR, Abols A, Xavier CPR, Line A. Extracellular vesicles as a novel source of biomarkers in liquid biopsies for monitoring cancer progression and drug resistance. Drug Resist Updat. 2019 Dec;47:100647. doi: 10.1016/j.drup.2019.100647. Epub 2019 Oct 15.
Jeppesen DK, Fenix AM, Franklin JL, Higginbotham JN, Zhang Q, Zimmerman LJ, Liebler DC, Ping J, Liu Q, Evans R, Fissell WH, Patton JG, Rome LH, Burnette DT, Coffey RJ. Reassessment of Exosome Composition. Cell. 2019 Apr 4;177(2):428-445.e18. doi: 10.1016/j.cell.2019.02.029.
Vu LT, Gong J, Pham TT, Kim Y, Le MTN. microRNA exchange via extracellular vesicles in cancer. Cell Prolif. 2020 Nov;53(11):e12877. doi: 10.1111/cpr.12877. Epub 2020 Oct 6.
Li B, Cao Y, Sun M, Feng H. Expression, regulation, and function of exosome-derived miRNAs in cancer progression and therapy. FASEB J. 2021 Oct;35(10):e21916. doi: 10.1096/fj.202100294RR.
Lu TX, Rothenberg ME. MicroRNA. J Allergy Clin Immunol. 2018 Apr;141(4):1202-1207. doi: 10.1016/j.jaci.2017.08.034. Epub 2017 Oct 23.
Mathieu M, Martin-Jaular L, Lavieu G, Thery C. Specificities of secretion and uptake of exosomes and other extracellular vesicles for cell-to-cell communication. Nat Cell Biol. 2019 Jan;21(1):9-17. doi: 10.1038/s41556-018-0250-9. Epub 2019 Jan 2.
Wang L, Yin P, Wang J, Wang Y, Sun Z, Zhou Y, Guan X. Delivery of mesenchymal stem cells-derived extracellular vesicles with enriched miR-185 inhibits progression of OPMD. Artif Cells Nanomed Biotechnol. 2019 Dec;47(1):2481-2491. doi: 10.1080/21691401.2019.1623232.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Z191100006619042
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CMUSH-IRB-KJ-PJ-2020-10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.