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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05072327
Other study ID # yanghs20200921
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date December 2025

Study information

Verified date October 2021
Source Sun Yat-sen University
Contact Huasheng Yang, M.D, PHD
Phone +862087331539
Email yanghs64@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aim to investigate whether the prognosis of eyelid malignant tumor is better treated with Mohs surgery combind with cryotherapy than Mohs surgery only.


Description:

This study is a randomized perspective study. American Joint Committee on Cancer was applied to define the cancer stage of patients recruited. Patients with Tis to T3cN0M0 will be randomized to receive Mohs surgery or Mohs suregery conbind cryotherapy. Patients will be followed for 3 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Ability to provide written informed consent and comply with study assessments for the full duration of this study. - Definite pathology signs of eyelid basal cell carcinoma, squamous cell carcinoma and sebacous carcinoma, Stage Tis to T3CN0M0 based on American Joint Committee on Cancer. - Pathological examination showed the primary tumor was compeletely resected Exclusion Criteria: - Any previous treatment in the study eye - Tumor complicated with infection - Any other tumors of the paticipants - Intolerate of surgery or anesthesia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mohs surgery
Mohs surgery of eyelid
cryotherapy
cryotherapy of eyelid

Locations

Country Name City State
China Zhongshan Ophthalmic Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary recurrence rate of tumor measure the tumor recurrence rate for the two groups at three years three years
Primary progression rate of tumor measure the tumor progression rate for the two groups at three years three years
Secondary all cause mortailty measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at three years three years
Secondary side effects of Mohs surgery and cryotherapy in the treatment of eyelid malignant tumor numbers of participants with side effects three years
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