Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery
NCT ID: NCT06725082
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2024-12-01
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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).
Recombinant 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.
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.
Recombinant 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.
Interventions
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Recombinant 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.
Eligibility Criteria
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Inclusion Criteria
2. Clinical and imaging diagnosis of breast tumor, planned for needle biopsy;
3. Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy;
4. No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening;
5. ECOG Performance Status (PS) - 0 or 1;
6. Subjects voluntarily join this study and sign the informed consent form.
Exclusion Criteria
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.
18 Years
80 Years
FEMALE
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Shu Wang
professor，director of breast center
Locations
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Peking University People's Hospital
Beijing, China, China
Countries
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Central Contacts
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Facility Contacts
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Mengmeng Zhang
Role: primary
Other Identifiers
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PKUPH2024PHD011-001
Identifier Type: -
Identifier Source: org_study_id