Detection of recirculating tumor-associated tissue macrophages and circulating melanoma cells as a tool for monitoring melanoma patients: a pilot study.
- Conditions
- Melanomaskin cancer10040900
- Registration Number
- NL-OMON54197
- Lead Sponsor
- Immunologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2
General: • At least 18 years old • Able to understand the patient information • Diagnosed with, or a lesion high likelihood of, a cutaneous melanoma Phase 1: • Skin lesion with a diameter of >1 cm, highly likely of melanoma or loco-regional metastases, including local recurrences and in-transit metastasis or hematogenic or lymphogenic metastasis. Phase 2A: • Bulky lymph node disease who undergo debulking surgery. Phase 2B: • Hematogenic or lymphogenic metastasis who undergo debulking surgery. Phase 3: • Different control groups: lichen planus, psoriasis, dermatitis, vitiligo, atopic eczema, and individuals with >100 moles.
• Immune disorders other than stated in the control groups
• Patients undergoing systemic cytotoxic or immunosuppressant therapy
• Uveal or mucosal melanoma
• Anamnestic pregnancy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The number of TiMas containing melanocyte and/or melanoma-specific peptides in<br /><br>their phagolysosomes and circulating melanoma cells in peripheral blood,<br /><br>expressed as percentage per total circulating TiMas and as absolute count<br /><br>(cells/microliter).</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Identification of proteins present in melanocytes and melanoma cells and<br /><br>their possible post-digestion peptides.<br /><br>- Proof of recirculation of tissue macrophages (containing post-digestion<br /><br>peptides) from the tissue of origin (skin/ epithelial layer) to peripheral<br /><br>blood via the lymph system.<br /><br>- Investigate the presence of circulating melanoma cells and recirculating<br /><br>tissue macrophages (containing post-digestion peptides) in lymph nodes by flow<br /><br>cytometry and evaluate the possible support of this analysis in staging<br /><br>methodologies performed by the pathologist.<br /><br>- Evaluate the *normal background* of melanoma/melanocyte peptide positive<br /><br>recirculating TiMas in healthy individuals and in patients with other<br /><br>(non-melanoma) skin diseases, such as inflammatory diseases.</p><br>