Detection of recirculating tumor-associated tissue macrophages and circulating melanoma cells as a tool for monitoring melanoma patients: a pilot study.

Detection of recirculating tumor-associated tissue macrophages and circulating melanoma cells as a tool for monitoring melanoma patients: a pilot study. - MelanoScan

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54197

Enrollment

100

Registered

2021-07-16

Start date

2022-01-06

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma skin cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: • Immune disorders other than stated in the control groups • Patients undergoing systemic cytotoxic or immunosuppressant therapy • Uveal or mucosal melanoma • Anamnestic pregnancy

Design outcomes

Primary

Measure	Time frame
The number of TiMas containing melanocyte and/or melanoma-specific peptides in their phagolysosomes and circulating melanoma cells in peripheral blood, expressed as percentage per total circulating TiMas and as absolute count (cells/microliter).	—

Secondary

Measure	Time frame
- Identification of proteins present in melanocytes and melanoma cells and their possible post-digestion peptides. - Proof of recirculation of tissue macrophages (containing post-digestion peptides) from the tissue of origin (skin/ epithelial layer) to peripheral blood via the lymph system. - Investigate the presence of circulating melanoma cells and recirculating tissue macrophages (containing post-digestion peptides) in lymph nodes by flow cytometry and evaluate the possible support of this analysis in staging methodologies performed by the pathologist. - Evaluate the normal background of melanoma/melanocyte peptide positive recirculating TiMas in healthy individuals and in patients with other (non-melanoma) skin diseases, such as inflammatory diseases.	—

Measure

Time frame

- Identification of proteins present in melanocytes and melanoma cells and their possible post-digestion peptides. - Proof of recirculation of tissue macrophages (containing post-digestion peptides) from the tissue of origin (skin/ epithelial layer) to peripheral blood via the lymph system. - Investigate the presence of circulating melanoma cells and recirculating tissue macrophages (containing post-digestion peptides) in lymph nodes by flow cytometry and evaluate the possible support of this analysis in staging methodologies performed by the pathologist. - Evaluate the *normal background* of melanoma/melanocyte peptide positive recirculating TiMas in healthy individuals and in patients with other (non-melanoma) skin diseases, such as inflammatory diseases.

—

Countries

Netherlands

Outcome results