Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors.

October 3, 2021 updated by: Huasheng Yang, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huasheng Yang, M.D, PHD
  • Phone Number: +862087331539
  • Email: yanghs64@126.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mohs surgery conbind with cryotherapy
patients in this group received both Mohs surgery and cryotherapy.
Procedure: Mohs surgery
Mohs surgery of eyelid
Procedure: cryotherapy
cryotherapy of eyelid
Active Comparator: Mohs surgery
patients in this group received only Mohs surgery.
Procedure: Mohs surgery
Mohs surgery of eyelid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate of tumor
Time Frame: three years
measure the tumor recurrence rate for the two groups at three years
three years
progression rate of tumor
Time Frame: three years
measure the tumor progression rate for the two groups at three years
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause mortailty
Time Frame: three years
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at three years
three years
side effects of Mohs surgery and cryotherapy in the treatment of eyelid malignant tumor
Time Frame: three years
numbers of participants with side effects
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Huasheng Yang, Doctor, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

October 3, 2021

First Submitted That Met QC Criteria

October 3, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 3, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yanghs20200921

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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