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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB number | Other Identifier | 2025-A02943-46 |
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The underlying hypothesis of the study is that melanoma patients treated with immunotherapy, whether in an adjuvant or curative setting, who consume more fiber would respond better to immunotherapy: either no recurrence in the case of adjuvant treatments, or no progression (disease stability, partial or complete response) in the case of curative treatments.
The primary objective is to evaluate the association between total dietary fiber intake quantified using the FiberTAG questionnaire and response to immunotherapy treatment in patients treated for melanoma in a curative or adjuvant setting
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| Measure | Description | Time Frame |
|---|---|---|
| Association between total dietary fiber intake based on the FiberTAG questionnaire and response to immunotherapy treatment in patients treated for melanoma in a curative or adjuvant setting | Objective response rate to immunotherapy according to RECIST 1.1 criteria | follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| Measure | Description | Time Frame |
|---|---|---|
| association between a high-fiber diet and the occurrence of immunotoxicity | Occurrence of immunotoxicity with its CTCAE v5.0 | during 6 months of immunotherapy initiation |
| association between muscle surface index on L3 CT scan using ODIASP software (Automated Computerized Muscle Surface Determination Tool at the Psoas Level) and response to immunotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated by immunotherapy for melanoma in curative or adjuvant settings for less than one year in the dermatology day hospital at Grenoble Alpes University Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Charles, MD, PhD | Contact | 0476769320 | +33 | jcharles@chu-grenoble.fr |
| Stéphane Mouret, PhD | Contact | 0476767081 | +33 | smouret1@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julie Charles, MD, PhD | University Grenoble Alpes Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Muscle surface index on L3 CT scan using ODIASP software and objective response rate to immunotherapy |
| follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| association between the presence of malnutrition at the start of treatment and response to immunotherapy | Presence of malnutrition at the start of treatment and objective response rate to immunotherapy | follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| association between high physical activity (GPAQ (Global Physical Activity Questionnaire) score) and response to immunotherapy | High physical activity (GPAQ score) and objective response rate to immunotherapy | follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| association between uncontrolled diabetes (HbA1c > 7%) and response to immunotherapy | Uncontrolled diabetes (HbA1c > 7%) and objective response rate to immunotherapy | follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| association between antibiotic use in the 3 months prior to the start of treatment and response to immunotherapy | Antibiotic use within 3 months prior to the start of treatment and objective response rate to immunotherapy | follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| association between prebiotic or probiotic use and response to immunotherapy | Pre- or probiotic intake and objective response rate to immunotherapy | follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| ssociation between alcohol consumption and response to immunotherapy | Alcohol consumption and objective response rate to immunotherapy | follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| association between tobacco consumption and response to immunotherapy | Tobacco consumption and objective response rate to immunotherapy | follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| Association between the presence of a pet in the patient's home and response to immunotherapy | Presence of a pet in the patient's home and objective response rate to immunotherapy | follow-up imaging at 3 and 6 months in curative and adjuvant settings |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |