NCT05072327

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

5.1 years

First QC Date

October 3, 2021

Last Update Submit

October 3, 2021

Conditions

Eyelid Tumor

Keywords

Eyelid TumorBasal Cell CarcinomaSquamous Cell CarcinomaSebaceous CarcinomaMohs surgerycryotherapy

Outcome Measures

Primary Outcomes (2)

  • recurrence rate of tumor

    measure the tumor recurrence rate for the two groups at three years

    three years

  • progression rate of tumor

    measure the tumor progression rate for the two groups at three years

    three years

Secondary Outcomes (2)

  • all cause mortailty

    three years

  • side effects of Mohs surgery and cryotherapy in the treatment of eyelid malignant tumor

    three years

Study Arms (2)

Mohs surgery conbind with cryotherapy

EXPERIMENTAL

patients in this group received both Mohs surgery and cryotherapy.

Procedure: Mohs surgeryProcedure: cryotherapy

Mohs surgery

ACTIVE COMPARATOR

patients in this group received only Mohs surgery.

Procedure: Mohs surgery

Interventions

Mohs surgeryPROCEDURE

Mohs surgery of eyelid

Mohs surgeryMohs surgery conbind with cryotherapy
cryotherapyPROCEDURE

cryotherapy of eyelid

Mohs surgery conbind with cryotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any previous treatment in the study eye
  • Tumor complicated with infection
  • Any other tumors of the paticipants
  • Intolerate of surgery or anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Eyelid NeoplasmsCarcinoma, Basal CellCarcinoma, Squamous CellAdenocarcinoma, Sebaceous

Interventions

Mohs SurgeryCryotherapy

Condition Hierarchy (Ancestors)

Facial NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsEye NeoplasmsEye DiseasesEyelid DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Basal CellNeoplasms, Squamous CellAdenocarcinomaNeoplasms, Adnexal and Skin Appendage

Intervention Hierarchy (Ancestors)

MicrosurgerySurgical Procedures, OperativeDermatologic Surgical ProceduresPlastic Surgery ProceduresTherapeutics

Study Officials

  • Huasheng Yang, Doctor

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Huasheng Yang, M.D, PHD

CONTACT

+862087331539yanghs64@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sun Yat-sen University

Study Record Dates

First Submitted

October 3, 2021

First Posted

October 8, 2021

Study Start

October 15, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

October 8, 2021

Record last verified: 2021-10

Locations

CN(1)