Sarcoma, Soft TissueNCT06550765
Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors
A study testing Biodegradable Magnesium Metal Clips in people with Sarcoma, Soft Tissue and Sarcoma, Spindle Cell, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
To verify and evaluate the safety and efficacy of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sarcoma, Soft Tissue, Sarcoma, Spindle Cell
- What is being tested?
- Biodegradable Magnesium Metal Clips
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be of either gender, aged between 18 and 65 years;
- Diagnosis must be confirmed pathologically as osteosarcoma, synovial sarcoma, liposarcoma, or other bone and soft tissue sarcomas;
- Must have undergone standard chemotherapy and require en bloc resection;
- Participants must voluntarily enroll and sign an informed consent form; willing to closely cooperate with the physician to comply with all study requirements, including participation in all follow-up and assessments.
Who cannot join
- Severe dysfunction of the heart, liver, kidney, lung, or brain.
- Pregnant women or women who are breastfeeding.
- History of autoimmune disease, HIV infection, history of immunosuppressive disorder, or currently taking immunosuppressive drugs.
- History of syphilis (Treponema pallidum), active infection with hepatitis B or C, and positive for verified antigens.
- Participation in any other clinical study currently or within 3 months prior to the screening visit.
- Patients have any other conditions that the researcher deems unsuitable for the study. Age is between 18 to 75 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors: A Single-Center, Randomized Controlled Study
To verify and evaluate the safety and efficacy of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors.
Read the detailed description
The purpose of this study is to verify and evaluate the safety and effectiveness of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors. The study will be divided into two groups:
Experimental Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.
Control Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Electrocautery and suture ligation are used to handle the tumor bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.
- Conditions
- Sarcoma, Soft Tissue, Sarcoma, Spindle Cell
- Being tested
- Biodegradable Magnesium Metal Clips
- Keywords
- Soft Tissue sarcoma, biodegradable magnesium metal
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable Magnesium Metal ClipsDevice
The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The tumor lesion area is exposed using conventional surgery methods, and the tumor segment is resected according to the principles of tumor-free operation. Electrocautery and suture ligation are used to handle the tumor bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed. |
| Magnesium metal closure clips | Experimental | The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed. Receives: Device: Biodegradable Magnesium Metal Clips |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year tumor recurrence rate
Calculate the recurrence rate of the tumor one year after surgery.
Measured: 1 year
Total drainage volume
Placement of a drainage tube in the surgical area, with postoperative drainage volumes recorded on the first, second, third, and fourth days.
Measured: on the first, second, third, and fourth postoperative days.
Secondary outcomes (4)
Blood magnesium ions levels
Measure the magnesium ions levels in the blood before surgery, one month after surgery, and six months after surgery.
Magnesium ions in the blood are measured in mmol/L. The normal range of serum magnesium is 0.75 to 1.25 mmol/L. Hypermagnesemia is defined as serum magnesium levels greater than 1.25 mmol/L, and hypomagnesemia is defined as serum magnesium levels less than 0.75 mmol/L. Assess the impact of the degradation of the biodegradable enzyme-metal clip on the magnesium ions in the blood, and thereby evaluate its safety for the human body.
Measured: at one month and six months after the operation
Serum alanine aminotransferase (ALT)
Venous blood is collected and sent to Guangdong Provincial People's Hospital Department of Laboratory Medicine for analysis one month and six months after surgery.
The normal range of serum alanine aminotransferase (ALT) is 7 to 40 U/L. When ALT is beyond the normal range, we consider that the biodegradable magnesium metal clip has caused liver damage during its degradation process, thus evaluating the safety of the metal clip.
Measured: at one month and six months after the operation
Serum creatinine
For normal renal function, the serum creatinine levels are 0.6 - 1.2 mg/dL (53 - 106 µmol/L) for adult males and 0.5 - 1.1 mg/dL (44 - 97 µmol/L) for adult females. Mild renal impairment is indicated by serum creatinine levels of 1.3 - 1.9 mg/dL (115 - 168 µmol/L) in males and 1.2 - 1.8 mg/dL (106 - 159 µmol/L) in females. Moderate renal impairment is reflected by levels of 2.0 - 4.0 mg/dL (177 - 354 µmol/L) in males and 1.9 - 4.0 mg/dL (168 - 354 µmol/L) in females. Severe renal impairment is indicated by serum creatinine levels of 4.1 - 8.0 mg/dL (362 - 707 µmol/L) for both genders. End-stage renal disease (ESRD) is classified by serum creatinine levels greater than 8.0 mg/dL (>707 µmol/L) for both genders. These classifications may vary based on specific clinical standards or guidelines and should be considered in conjunction with other clinical indicators and professional medical judgment.
Measured: at one month and six months after the operation
Estimated glomerular filtration rate (eGFR）
The estimated glomerular filtration rate (eGFR) is a key indicator of kidney function, used to classify chronic kidney disease (CKD) into different stages:
Stage 1: eGFR ≥ 90 mL/min/1.73 m², indicating normal kidney function. Stage 2: eGFR 60-89 mL/min/1.73 m², representing mildly decreased kidney function.
Stage 3: Divided into two sub-stages:
Stage 3a: eGFR 45-59 mL/min/1.73 m², indicating moderate kidney impairment. Stage 3b: eGFR 30-44 mL/min/1.73 m², reflecting more significant kidney dysfunction.
Stage 4: eGFR 15-29 mL/min/1.73 m², showing severe kidney impairment. Stage 5: eGFR < 15 mL/min/1.73 m² or requiring dialysis, indicating kidney failure.
These eGFR values help in evaluating kidney function and determining the appropriate treatment approach, with specific adjustments based on clinical guidelines and individual patient factors.
Measured: at one month and six months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start25 Aug 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550765
- Sponsor's protocol ID
- PureMgBoneCuttingEdge
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers can request access from the corresponding author upon reasonable inquiry.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors: A Single-Center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06550765
- Acronym / sponsor ID
- PureMgBoneCuttingEdge
- Conditions
- Sarcoma, Soft Tissue, Sarcoma, Spindle Cell
- Keywords
- Soft Tissue sarcoma, biodegradable magnesium metal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 25 Aug 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Aug 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.
To verify and evaluate the safety and efficacy of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors.
Detailed description
The purpose of this study is to verify and evaluate the safety and effectiveness of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors. The study will be divided into two groups:
Experimental Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.
Control Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Electrocautery and suture ligation are used to handle the tumor bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The tumor lesion area is exposed using conventional surgery methods, and the tumor segment is resected according to the principles of tumor-free operation. Electrocautery and suture ligation are used to handle the tumor bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed. |
| Magnesium metal closure clips | Experimental | Device: Biodegradable Magnesium Metal ClipsThe tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be of either gender, aged between 18 and 65 years;
- Diagnosis must be confirmed pathologically as osteosarcoma, synovial sarcoma, liposarcoma, or other bone and soft tissue sarcomas;
- Must have undergone standard chemotherapy and require en bloc resection;
- Participants must voluntarily enroll and sign an informed consent form; willing to closely cooperate with the physician to comply with all study requirements, including participation in all follow-up and assessments.
Key exclusion criteria (6 listed)
- Severe dysfunction of the heart, liver, kidney, lung, or brain.
- Pregnant women or women who are breastfeeding.
- History of autoimmune disease, HIV infection, history of immunosuppressive disorder, or currently taking immunosuppressive drugs.
- History of syphilis (Treponema pallidum), active infection with hepatitis B or C, and positive for verified antigens.
- Participation in any other clinical study currently or within 3 months prior to the screening visit.
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 |
|---|---|---|
| Biodegradable Magnesium Metal ClipsThe tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed. | Device | Magnesium metal closure clips |
Primary outcome
1-year tumor recurrence rate
Time frame: 1 year
Calculate the recurrence rate of the tumor one year after surgery.
Total drainage volume
Time frame: on the first, second, third, and fourth postoperative days.
Placement of a drainage tube in the surgical area, with postoperative drainage volumes recorded on the first, second, third, and fourth days.
4 secondary outcomes
Blood magnesium ions levels
Time frame: at one month and six months after the operation
Serum alanine aminotransferase (ALT)
Time frame: at one month and six months after the operation
Serum creatinine
Time frame: at one month and six months after the operation
Estimated glomerular filtration rate (eGFR）
Time frame: at one month and six months after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No. Researchers can request access from the corresponding author upon reasonable inquiry.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodegradable Magnesium Metal Clips in people with Sarcoma, Soft Tissue and Sarcoma, Spindle Cell, run by Guangdong Provincial People's Hospital 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Aug 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang, Ph.D. (8613602744495, luck_2001@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year tumor recurrence rate (time frame: 1 year). 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 13 Aug 2024.