Eyelid TumorNCT05072327
Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors.
A study testing Mohs surgery and cryotherapy in people with Eyelid Tumor, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eyelid Tumor
- What is being tested?
- Mohs surgery and cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any previous treatment in the study eye
- Tumor complicated with infection
- Any other tumors of the paticipants
- Intolerate of surgery or anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
Huasheng Yang, M.D, PHD, +862087331539, yanghs64@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Eyelid Tumor
- Being tested
- Mohs surgery, cryotherapy
- Keywords
- Eyelid Tumor, Basal Cell Carcinoma, Squamous Cell Carcinoma, Sebaceous Carcinoma, Mohs surgery, cryotherapy
- Medical subject headings
- Eyelid Neoplasms, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Adenocarcinoma, Sebaceous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mohs surgeryProcedure or surgery
Mohs surgery of eyelid
cryotherapyProcedure or surgery
cryotherapy of eyelid
| Study group | Role | What they receive |
|---|---|---|
| Mohs surgery conbind with cryotherapy | Experimental | patients in this group received both Mohs surgery and cryotherapy. Receives: Procedure: Mohs surgery; Procedure: cryotherapy |
| Mohs surgery | Active comparator | patients in this group received only Mohs surgery. Receives: Procedure: Mohs surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate of tumor
measure the tumor recurrence rate for the two groups at three years
Measured: three years
progression rate of tumor
measure the tumor progression rate for the two groups at three years
Measured: three years
Secondary outcomes (2)
all cause mortailty
measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at three years
Measured: three years
side effects of Mohs surgery and cryotherapy in the treatment of eyelid malignant tumor
numbers of participants with side effects
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start15 Oct 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huasheng Yang, Sun Yat-sen University
- Investigators
- Huasheng Yang, Doctor, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072327
- Sponsor's protocol ID
- yanghs20200921
- Status last verified
- Oct 2021
- First submitted
- 3 Oct 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors: a Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05072327
- Acronym / sponsor ID
- yanghs20200921
- Conditions
- Eyelid Tumor
- Keywords
- Eyelid Tumor, Basal Cell Carcinoma, Squamous Cell Carcinoma, Sebaceous Carcinoma, Mohs surgery, cryotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mohs surgery conbind with cryotherapy | Experimental | Procedure: Mohs surgery, Procedure: cryotherapypatients in this group received both Mohs surgery and cryotherapy. |
| Mohs surgery | Active comparator | Procedure: Mohs surgerypatients in this group received only Mohs surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Any previous treatment in the study eye
- Tumor complicated with infection
- Any other tumors of the paticipants
- Intolerate of surgery or anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mohs surgeryMohs surgery of eyelid | Procedure or surgery | Mohs surgery, Mohs surgery conbind with cryotherapy |
| cryotherapycryotherapy of eyelid | Procedure or surgery | Mohs surgery conbind with cryotherapy |
Primary outcome
recurrence rate of tumor
Time frame: three years
measure the tumor recurrence rate for the two groups at three years
progression rate of tumor
Time frame: three years
measure the tumor progression rate for the two groups at three years
2 secondary outcomes
all cause mortailty
Time frame: three years
side effects of Mohs surgery and cryotherapy in the treatment of eyelid malignant tumor
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huasheng Yang, Doctor study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mohs surgery and cryotherapy in people with Eyelid Tumor, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huasheng Yang, M.D, PHD (+862087331539, yanghs64@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate of tumor (time frame: three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.