An observational study in Oral Leukoplakia and Oral Cancer, sponsored by Beijing Stomatological Hospital, Capital Medical University. Completed at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Beijing Stomatological Hospital, Capital Medical University · Observational
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:
Participants will be asked to:
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.
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
This study's enrollment of 225 is above the median of 97 across 20 observational studies indexed under Leukoplakia, Oral.
Browse Leukoplakia, Oral studies →Beijing Stomatological Hospital, Capital Medical University is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants were from the Department of Stomatology, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: Baseline, pre-biopsy surgery.
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form, Clinical study report
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.
Data sharing details ↗ · www.medresman.org.cn
Ran from Jun 2020 to primary completion in Jun 2023, 36 months.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Beijing Stomatological Hospital, Capital Medical University