Saliva and Plasma Exosomes for Oral Leukoplakia Malignant Transformation Diagnosis and Oral Cancer Prognosis Monitoring

NCT06469892 | Completed DMC

• 2 other identifiers: CMUSH-IRB-KJ-PJ-2020-10Z191100006619042
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Oral Leukoplakia; Oral Cancer

Keywords

Oral cancer; Oral leukoplakia; Exosome; miR-185; Diagnosis; Prognosis

Outcome Measures

Primary Outcomes (2)

• The expression level of miR-185 in salivary exosomes

  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.

  Baseline, pre-biopsy surgery.

• The expression level of miR-185 in plasma exosomes

  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.

  Baseline, pre-biopsy surgery.

Interventions

Detect the expression level of miR-185 in salivary and plasma exosomes. OTHER

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

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were from the Department of Stomatology, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.

You may qualify if:

• Males or females aged 30\~80 years.
• 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.

You may not qualify if:

• Pathological diagnosis of another disease rather than oral leukoplakia or squamous cell carcinoma.
• 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.

Sponsors & Collaborators

• Beijing Stomatological Hospital, Capital Medical University: lead

Study Sites (1)

Beijing Stomatological Hospital, Capital Medical University

Beijing, Beijing Municipality, 100010, China

Location

Related Publications (14)

• 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: 26316588 BACKGROUND

• 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: 33251978 BACKGROUND

• 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: 29454608 BACKGROUND

• 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: 30907490 BACKGROUND

• 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: 38193375 BACKGROUND

• 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: 24009894 BACKGROUND

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  PMID: 28495994 BACKGROUND

• 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: 31704541 BACKGROUND

• 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: 30951670 BACKGROUND

• 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: 33169503 BACKGROUND

• 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: 34510546 BACKGROUND

• 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: 29074454 BACKGROUND

• 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.

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• 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.

  PMID: 31219352 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and plasma samples will be retained.

MeSH Terms

Conditions

Leukoplakia, Oral; Mouth Neoplasms; Disease

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Xiaobing Guan, Ph.D.

  Beijing Stomatological Hospital, Capital Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor and Professor of Oral Medicine，and Director of Department of Oral Medicine

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: June 13, 2020
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 years after publication of all results.
• Access Criteria: 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. Applicants 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. Project Director Xiaobing Guan will be responsible for reviewing data access requests.

Locations

CN (1)