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

NCT06469892 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2024-06-24

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Beijing Stomatological Hospital, Capital Medical University

    lead OTHER

Principal Investigators

  • Xiaobing Guan, Ph.D. · Beijing Stomatological Hospital, Capital Medical University

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-13
Primary Completion
2023-06-30
Completion
2023-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06469892 on ClinicalTrials.gov