LymphedemaNCT06237907
Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
An observational study of Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- Patients underwent lymphedema surgery and Patients underwent surgery without LVA
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2023to 12 Jan 2026
- Phase
- Observational
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients as experimental group who has lymphedema and need to underwent surgery. Patients as control group who require surgery without lymphedema. Written informed consent was obtained from all patients.
Who may be able to join
- Control Group: Patients who have not experienced lymphedema but require surgery due to other diseases such as cancer, trauma, chronic wounds, skin defects, etc.
- Experimental Group: Patients who have lymphedema and undergone lymphedema surgery.
Who cannot join
- 1. Individuals with venous thrombosis, chronic heart failure, and renal failure.
- 2. Vulnerable populations, individuals with limited mobility, pregnant women, and minors.
- 3. Those expected to be unable to attend follow-up visits or complete the study smoothly.
- 4. Participants who express doubts about the trial and cannot provide satisfactory answers.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Hsiao-Yun Hsieh, MSc, +886-7-7317123 ext. 2947, sylvia19870714@hotmail.com
About this study
Official title: The Role of Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
The project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients.
Read the detailed description
This project aims to investigate the expression of cell death through apoptosis and iron-dependent cell death in the subcutaneous adipose tissue of patients with lymphedema. The study also seeks to explore the roles of these processes among lymphatic endothelial cells, adipocytes, and macrophages, and their association with lymphedema, thus gaining insights into the pathophysiological mechanisms of lymphedema. Furthermore, the project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients.
- Conditions
- Lymphedema
- Being tested
- Patients underwent lymphedema surgery, Patients underwent surgery without LVA
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients underwent lymphedema surgeryOther
Patients who have developed lymphedema and undergone lymphedema surgery.
Patients underwent surgery without LVAOther
For patients who have not experienced lymphedema but require surgery due to other disease such as cancer, trauma, chronic wounds, skin defects, etc.
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent surgery | Not described Receives: Other: Patients underwent lymphedema surgery; Other: Patients underwent surgery without LVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between post-LVA volume reduction
The differences in expression of cell necrosis and iron-dependent cell death after lymphedema surgery were observed in patients, following alleviation of edema symptoms.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start20 Sep 2023
- Primary completion20 Sep 2024 (estimated)
- Study completion12 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237907
- Sponsor's protocol ID
- 202201327B0
- Status last verified
- Sep 2023
- First submitted
- 16 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
- ClinicalTrials.gov ID
- NCT06237907
- Acronym / sponsor ID
- 202201327B0
- Conditions
- Lymphedema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 12 Jan 2026 (estimated)
- First posted
- 2 Feb 2024 (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.
The project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients.
Detailed description
This project aims to investigate the expression of cell death through apoptosis and iron-dependent cell death in the subcutaneous adipose tissue of patients with lymphedema. The study also seeks to explore the roles of these processes among lymphatic endothelial cells, adipocytes, and macrophages, and their association with lymphedema, thus gaining insights into the pathophysiological mechanisms of lymphedema. Furthermore, the project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent surgery | – | Other: Patients underwent lymphedema surgery, Other: Patients underwent surgery without LVA |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients as experimental group who has lymphedema and need to underwent surgery. Patients as control group who require surgery without lymphedema. Written informed consent was obtained from all patients.
Key inclusion criteria (2 listed)
- Control Group: Patients who have not experienced lymphedema but require surgery due to other diseases such as cancer, trauma, chronic wounds, skin defects, etc.
- Experimental Group: Patients who have lymphedema and undergone lymphedema surgery.
Key exclusion criteria (4 listed)
- 1. Individuals with venous thrombosis, chronic heart failure, and renal failure.
- 2. Vulnerable populations, individuals with limited mobility, pregnant women, and minors.
- 3. Those expected to be unable to attend follow-up visits or complete the study smoothly.
- 4. Participants who express doubts about the trial and cannot provide satisfactory answers.
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 |
|---|---|---|
| Patients underwent lymphedema surgeryPatients who have developed lymphedema and undergone lymphedema surgery. | Other | Patients underwent surgery |
| Patients underwent surgery without LVAFor patients who have not experienced lymphedema but require surgery due to other disease such as cancer, trauma, chronic wounds, skin defects, etc. | Other | Patients underwent surgery |
Primary outcome
The correlation between post-LVA volume reduction
Time frame: 1 month after surgery
The differences in expression of cell necrosis and iron-dependent cell death after lymphedema surgery were observed in patients, following alleviation of edema symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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 2 Feb 2024. 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 Taiwan. 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 Ching-Hua Hsieh, PhD (+886-7-7317123 ext. 2947, m93chinghua@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between post-LVA volume reduction (time frame: 1 month after surgery). 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 2 Feb 2024.