Association Between Helioderma and Response to Immunotherapy in Patients With Metastatic Melanoma

NCT05641012 | Unknown

• 1 other identifier: 2022_HELIOMA
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Melanoma is one of the most aggressive forms of skin cancer, representing only 5% of all skin cancer but 80% of all death by skin cancer. Diagnosis and treatment of melanoma must be early because prognosis depends on stage disease. Immunotherapy is used in metastatic melanoma. However, all patients not respond to immunotherapy. Helioderma (photoaging) is a marker of exposure to UV rays and therefore of mutagenesis. Thus, helioderma could be associated with the response to immunotherapy.

Conditions

Metastatic Melanoma

Keywords

metastatic melanoma; immunotherapy; helioderma; response

Outcome Measures

Primary Outcomes (1)

• Helioderma

  Helioderma (photoageing) evaluated around the resection scar or melanoma (if no resection) by descriptive scale ranging from 0 to 3 (3 corresponding to strong helioderma): * 0: no sign * 1: actinic lentigo, wrinkles, telangiectasia, loss of laxity, thinning * 2: thick, yellowish and/or dry skin, deep wrinkles, irregular pigmentation (hyper-hypopigmented spots) * 3: actinic keratosis, basal cell carcinoma, squamous cell carcinoma

  Day 0

Study Arms (1)

metastatic melanoma group

adult with metastatic melanoma treated by immunotherapy

Other: data collection

Interventions

data collection OTHER

helioderma evaluation

metastatic melanoma group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult with metastatic melanoma treated by immunotherapy

You may qualify if:

• metastatic melanoma
• Whatever the mutation BRAF status
• treated by immunotherapy or specific therapy
• aged more than 18
• agreeing to participate to the study

You may not qualify if:

• Patient whose treatment by immunotherapy has already started
• Patient who have had a radiotherapy or chemotherapy treatment
• Patient with an unknown primary melanoma, choroidal melanoma
• Patient with other cancer (except basal cell and squamous cell skin cancer)
• Patient with genetic predisposition for melanoma
• aged less than 18
• Adult not agreeing to participate to the study

Sponsors & Collaborators

• Institut Jean-Godinot: lead
• Université de Reims Champagne-Ardenne: collaborator

MeSH Terms

Conditions

Melanoma

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share