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Clinical study of optical coherence tomography (OCT / OCM) in the diagnosis of Oral Leukoplakia Carcinogenesis

Clinical study of optical coherence tomography (OCT / OCM) in the diagnosis of Oral Leukoplakia Carcinogenesis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050658
Enrollment
Unknown
Registered
2021-09-01
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Canceration of oral leukoplakia

Interventions

Gold Standard:Pathological diagnosis
(OCT&#32
OCM)&#32

Sponsors

Beijing Stomatological Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Test 1: (1) Men or women aged 18 to 70 years; (2) Biopsy pathological diagnosis of leukoplakia cancer; (3) Those who entered the Department of Head and Neck Oncology, Beijing Stomatological Hospital Affiliated to Capital Medical University after being confirmed by biopsy. 2. Test 2: (1) Men or women aged 18 to 70 years; (2) The clinical diagnosis of leukoplakia is ineffective after drug treatment or suspected of white spot cancer and needs to undergo excision or incision biopsy for pathological diagnosis.

Exclusion criteria

Exclusion criteria: 1. Test 1: (1) Patients with underlying diseases or other factors that cannot tolerate surgery; (2) Those with mental illness who cannot cooperate; (3) The preoperative lesion area has received radiotherapy, chemotherapy, laser, or the use of topical drugs in the lesion area within three months before surgery, and other treatment methods that affect the imaging effect of OCT/OCM; (4) Some other situations that the researchers think are inappropriate to participate. 2. Test 2: (1) Those who are accompanied by underlying diseases or other factors and cannot tolerate biopsy surgery; (2) Those with mental illness who cannot cooperate; (3) The preoperative lesion area has received radiotherapy, chemotherapy, laser, or the use of topical drugs in the lesion area within three months before surgery, and other treatment methods that affect the imaging effect of OCT/OCM; (4) Pregnant or lactating women; (5) Some other situations that the researcher considers inappropriate to participate.

Design outcomes

Primary

MeasureTime frame
Structural changes and boundaries of keratinized layer in oral leukoplakia;Is the continuity of the basement membrane of oral leukoplakia intact;Thickness changes of leukoplakia epithelium in oral mucosa;Changes of echo intensity of leukoplakia epithelium in oral mucosa;Morphological changes of oral leukoplakia epithelial cells;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactHuang Xin

Beijing Stomatological Hospital Affiliated to Capital Medical University

huangxin@ccmu.edu.cn+86 15810332248

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026