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

November 28, 2022 updated by: Institut Jean-Godinot

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The detection and management of melanomas must be very early because the prognosis largely depends on the extent of the disease at the time of diagnosis.

For patients with melanoma, immunotherapy or dual therapy is used as treatment in unresectable and metastatic (AJCC stage IV) cases, depending on mutation status. Primary immunotherapy is possible in mutated patients in the absence of threatening progression.

However, not all patients respond well to immunotherapy, so biomarkers that predict treatment response are needed to optimize patient benefit.

The onset, development, and course of melanoma are based on the accumulation of genomic changes, including high loads of ultraviolet-induced mutations, which make melanoma the most immunogenic tumor. In several tumor types, tumor mutation load (TMB) and immune infiltration have been reported to predict response to immunotherapy. Indeed, the higher the TMB, the more the tumor is likely to produce a neo-tumor antigen, target of the reactivation of the immune system.

No threshold value of TMB has been determined to date, having a predictive value in melanoma. The degree of helioderma could be a potentially discriminating marker of the degree of UV exposure and therefore of mutagenesis. Preliminary results have reported the interest of this approach but must be confirmed because it was a small study (Russo et al).

UV-induced DNA damage results in clinical signs of heliodermia or photoaging: more or less deep wrinkles, loss of elasticity, thinning of the skin, lentigo pigmentary disorders, yellowish color of the skin, telangiectasias, on the skin areas exhibited. Helioderma could therefore be an easily accessible clinical predictor of a good response to immunotherapy.

The aim of the study is to study association between helioderma and response to immunotherapy in patients with metastatic melanoma.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult with metastatic melanoma treated by immunotherapy

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
metastatic melanoma group
adult with metastatic melanoma treated by immunotherapy
Other: data collection
helioderma evaluation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Helioderma
Time Frame: Day 0

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Jean-Godinot

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Université de Reims Champagne-Ardenne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2022

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022_HELIOMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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