Actively Recruiting
Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery
Led by Peking University People's Hospital · Updated on 2024-12-10
30
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Breast tumors, particularly breast cancer, are increasingly prevalent in China, with a noticeable trend towards younger ages. Preliminary research indicates that Type III Collagen (COL3) plays a crucial role in tissue and organ protection within the tumor microenvironment and can inhibit tumor progression through microenvironmental remodeling. However, there are no clinical studies related to COL3 in breast tumors. This project aims to initiate a multicenter, prospective, randomized, open-label, parallel-controlled trial by locally administering recombinant humanized Type III Collagen (rhCOL3) to patients undergoing breast tumor surgery. The study will observe the incidence of perioperative complications after rhCOL3 injection, as well as changes in aesthetic outcomes and tumor-related pathological indicators following breast tumor surgery with local rhCOL3 injection. The goal is to establish a targeted rhCOL3 local injection therapy with dual functions of local protection and synergistic treatment, providing a new strategy for the treatment of breast tumors.
CONDITIONS
Official 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 aged 18 years or older but not exceeding 80 years
- Clinical and imaging diagnosis of breast tumor with planned needle biopsy
- Planned breast tumor surgery and possible whole-breast radiotherapy
- No prior systemic or local anti-tumor treatment before screening
- ECOG Performance Status of 0 or 1
- Voluntary participation with signed informed consent
You will not qualify if you...
- Bilateral or multiple breast lesions
- Skin damage or ulceration on the affected breast side
- Allergy history to collagen products or severe allergic constitution
- History of breast cancer or other malignant tumors
- Positive pregnancy test or currently breastfeeding
- Use of anticoagulant or antiplatelet drugs
- Severe other diseases such as cardiovascular, blood, autoimmune, neurological, or psychiatric disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China, China, 100044
Actively Recruiting
Research Team
M
Mengmeng Zhang
CONTACT
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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