RecruitingPhase 1NCT06725082

Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery

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


Sponsor

Peking University People's Hospital

Enrollment

30 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether applying a recombinant (lab-made) humanized collagen gel during and after breast tumor surgery can reduce complications, improve healing, and support better cosmetic outcomes. **You may be eligible if...** - Female, age 18–80 - Have a breast tumor confirmed by clinical exam or imaging, and are scheduled for a needle biopsy - Are planning to have breast tumor surgery, possibly followed by radiation therapy - Have not received any cancer treatment prior to the planned surgery **You may NOT be eligible if...** - Have already received systemic cancer treatment or local treatment for this tumor - Have a known allergy to collagen products - Have serious bleeding disorders or conditions that impair wound healing - Are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRecombinant Humanized Type III Collagen Injection

rhCOL3/saline will be injected around the tumor (at four points: outer upper, inner upper, outer lower, and inner lower) before surgery, with 500ul per site. 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), followed by routine tissue flap revision and suture.


Locations(1)

Peking University People's Hospital

Beijing, China, China

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NCT06725082


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