Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery: a Multicenter, Prospective, Randomized, Open-label, Parallel-controlled Trial Protocol
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Short-term postoperative complications after surgery and radiotherapy.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18 years or older but not exceeding 80 years;
- •Clinical and imaging diagnosis of breast tumor, planned for needle biopsy;
- •Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy;
- •No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening;
- •ECOG Performance Status (PS) - 0 or 1;
- •Subjects voluntarily join this study and sign the informed consent form.
排除标准
- •a.Tumor-related symptoms and treatments
- •1）Bilateral, multiple lesions; 2) Skin damage and ulceration on the affected side of the breast; b. History of allergy to collagen products or their excipients or severe allergic constitution; c. History of breast cancer or other malignant tumors; d. Positive serum pregnancy test or lactation; e. Use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs; f. With severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders, etc.
研究组 & 干预措施
rhCOL3 Injection Group
RhCOL3 will be prepared as a 4mg/ml and injected around the tumor. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, a second injection of 2ml will be administered around the surgical area skin (at points spaced along the skin incision).
干预措施: Recombinant Humanized Type III Collagen Injection (Biological)
Control Group
4ml of saline will be injected around the tumor before surgery. After the surgical margin is confirmed to be safe by rapid frozen pathology during surgery, 2ml of saline will be injected around the breast surgical area skin.
干预措施: Recombinant Humanized Type III Collagen Injection (Biological)
结局指标
主要结局
Short-term postoperative complications after surgery and radiotherapy.
时间窗: 3 month
The purpose of this study is to assess the incidence rate of short-term complications within 3 months after patients complete surgery and radiotherapy. The main complications are defined as surgery or radiotherapy-related complications occurring during postoperative follow-up, including delayed wound healing, partial skin necrosis, infection, and hematoma and seroma; common adverse reactions related to breast radiotherapy include acute radiation dermatitis, breast edema, pain, etc., and late-stage breast fibrosis, edema, atrophy, telangiectasia, etc.
次要结局
- Changes in clinical pathological indicators(3 month)
研究者
Shu Wang
professor，director of breast center
Peking University People's Hospital