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

June 19, 2024 updated by: Xiaobing Guan, Beijing Stomatological Hospital, Capital Medical University

Application of Salivary and Plasma Exosomes in the Diagnosis of Oral Leukoplakia Malignant Transformation and Prognosis Monitoring of Oral Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100010
        • Beijing Stomatological Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The expression level of miR-185 in salivary exosomes
Time Frame: Baseline, pre-biopsy surgery.
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
Time Frame: Baseline, pre-biopsy surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Stomatological Hospital, Capital Medical University

Investigators

  • Study Director: Xiaobing Guan, Ph.D., Beijing Stomatological Hospital, Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUSH-IRB-KJ-PJ-2020-10
  • Z191100006619042 (Other Grant/Funding Number: Beijing Municipal Science and Technology Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

IPD Sharing Time Frame

1 years after publication of all results.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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