Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-01 @ 11:54 AM
Study NCT ID:
NCT06469892
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2024-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Saliva and Plasma Exosomes for Oral Leukoplakia Malignant Transformation Diagnosis and Oral Cancer Prognosis Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007972', 'term': 'Leukoplakia, Oral'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007971', 'term': 'Leukoplakia'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva and plasma samples will be retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-19', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The expression level of miR-185 in salivary exosomes', 'timeFrame': 'Baseline, pre-biopsy surgery.', 'description': 'Exosomes were isolated from saliva using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR.'}, {'measure': 'The expression level of miR-185 in plasma exosomes', 'timeFrame': 'Baseline, pre-biopsy surgery.', 'description': 'Exosomes were isolated from plasma using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral cancer', 'Oral leukoplakia', 'Exosome', 'miR-185', 'Diagnosis', 'Prognosis'], 'conditions': ['Oral Leukoplakia', 'Oral Cancer']}, 'referencesModule': {'references': [{'pmid': '26316588', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33251978', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29454608', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30907490', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38193375', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '24009894', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '28495994', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31704541', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30951670', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33169503', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34510546', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29074454', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30602770', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31219352', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to test the expression levels of salivary and plasma exosomal miR-185 in patients with oral leukoplakia and oral squamous cell carcinoma. The main questions it aims to answer are:\n\n* Is it possible to identify the cancer risk of oral leukoplakia in its early stages by detecting salivary and plasma exosomal miR-185?\n* Is it possible to monitor the cancer risk of oral leukoplakia and the prognosis of oral cancer using salivary exosomal miR-185?\n\nParticipants will be asked to:\n\n* Cooperate with the investigators in completing the oral examination.\n* Take saliva and plasma before the biopsy surgery.\n* Perform the biopsy surgery following the usual diagnostic procedures.\n* Attend regular follow-up appointments (every 3 months) for the duration of the study.', 'detailedDescription': 'The first part of the study is a cross-sectional study in which the investigators will detect the expression level of salivary exosomal miR-185 in the participants at a single time point. The second part of the study is a prospective cohort study, in which the investigators will conduct regular follow-ups on the participants enrolled in the first part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants were from the Department of Stomatology, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females aged 30\\~80 years.\n* Clinical diagnosis consistent with oral leukoplakia and oral cancer.\n* Individuals with local stimulating factors correlated with oral lesions (including residual roots, residual crowns, poor oral restorations, cheek biting, and tongue biting habits).\n* Oral lesions not subjected to any treatment, including laser, photodynamic therapy, radiotherapy, and chemotherapy.\n\nExclusion Criteria:\n\n* Pathological diagnosis of another disease rather than oral leukoplakia or squamous cell carcinoma.\n* Females who were pregnant or breastfeeding.\n* 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.\n* Individuals with a psychiatric disorder.\n* Other conditions deemed inappropriate for study participation by the researchers.'}, 'identificationModule': {'nctId': 'NCT06469892', 'briefTitle': 'Saliva and Plasma Exosomes for Oral Leukoplakia Malignant Transformation Diagnosis and Oral Cancer Prognosis Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Stomatological Hospital, Capital Medical University'}, 'officialTitle': 'Application of Salivary and Plasma Exosomes in the Diagnosis of Oral Leukoplakia Malignant Transformation and Prognosis Monitoring of Oral Cancer', 'orgStudyIdInfo': {'id': 'CMUSH-IRB-KJ-PJ-2020-10'}, 'secondaryIdInfos': [{'id': 'Z191100006619042', 'type': 'OTHER_GRANT', 'domain': 'Beijing Municipal Science and Technology Commission'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Detect the expression level of miR-185 in salivary and plasma exosomes.', 'type': 'OTHER', 'description': '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.\n\nParticipants 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100010', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Stomatological Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xiaobing Guan, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Stomatological Hospital, Capital Medical University'}]}, 'ipdSharingStatementModule': {'url': 'http://www.medresman.org.cn', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': '1 years after publication of all results.', 'ipdSharing': 'YES', 'description': "Data on participants' gender, age, disease duration, lesion characteristics (location and size), tobacco, alcohol and betel nut consumption habits, histopathologic diagnosis, and miR-185 levels in saliva and plasma exosomes will be shared.", 'accessCriteria': "Share data in a standardized format adhering to unified standards. The data should be comprehensive, trustworthy, traceable to the source, timely, and gathered and processed using consistent methods. Furthermore, anonymity of participants' identity information is required.\n\nApplicants seeking permission to access the data must clearly specify the intended purpose of use. Access to the data will only be granted to authorized individuals who have executed a data use agreement with the investigators. Any unauthorized sharing of data or use of the data for commercial purposes is strictly forbidden.\n\nProject Director Xiaobing Guan will be responsible for reviewing data access requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Stomatological Hospital, Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor and Professor of Oral Medicine，and Director of Department of Oral Medicine', 'investigatorFullName': 'Xiaobing Guan', 'investigatorAffiliation': 'Beijing Stomatological Hospital, Capital Medical University'}}}}