Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors.

Eyelid Tumor Clinical Trial

Official title:

Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors: a Prospective Randomized Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05072327
• Other study ID #: yanghs20200921
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Eyelid Tumor
• Neoplasms

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