Actively Recruiting
Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery in a Multicenter, Randomized, Open-label Trial
Led by Peking University People's Hospital · Updated on 2024-12-10
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Breast tumors, especially breast cancer, are becoming more common in China with an increasing number of younger patients. Research suggests that Type III Collagen (COL3) plays an important role in protecting tissues and organs within the tumor environment and may slow tumor progression by remodeling this environment. However, no clinical studies have yet explored COL3 in breast tumors. This trial aims to study the effects of locally injecting recombinant humanized Type III Collagen (rhCOL3) during breast tumor surgery to assess its potential benefits and safety. Participants will be randomly assigned to one of two groups: one group will receive injections of rhCOL3 around the tumor before surgery and again around the surgical area skin after confirming safe surgical margins during surgery. The other group will receive saline injections following the same procedure as a control. The rhCOL3 will be given at specific points around the tumor and along the skin incision during surgery. This study is a multicenter, prospective, randomized, open-label, parallel-controlled trial. During the study, participants will be monitored for short-term complications after surgery and radiotherapy over a three-month period. Researchers will also observe changes in clinical pathological indicators related to the tumor. Assessments will include clinical and imaging evaluations, with follow-up visits to track outcomes. The goal is to establish whether local rhCOL3 injection can provide protection and support treatment in breast tumor surgery over both immediate and long-term periods.
CONDITIONS
Brief Title
Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 80 years
- Clinical and imaging diagnosis of breast tumor with planned needle biopsy
- Planned breast tumor surgery with possible whole-breast radiotherapy
- No prior systemic or local anti-tumor treatment before screening
- ECOG Performance Status of 0 or 1
- Signed informed consent to join the study
You will not qualify if you...
- Bilateral or multiple breast lesions
- Skin damage or ulceration on the affected breast side
- Allergy to collagen products or severe allergic constitution
- History of breast cancer or other malignant tumors
- Positive pregnancy test or currently breastfeeding
- Use of anticoagulant, antiplatelet, or non-steroidal anti-inflammatory drugs
- Severe comorbid diseases such as cardiovascular, blood, autoimmune, neurological, or psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive injections around the breast tumor and surgical area during surgery, followed by routine tissue flap revision and suture.
1 surgical visit (in-person)
Duration - 3 months
Participants are monitored for short-term postoperative complications and changes in clinical pathological indicators after surgery and radiotherapy.
Approximately 3 follow-up visits
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China, China, 100044
Actively Recruiting
Research Team
M
Mengmeng Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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