Dermato-oncology department, Ambroise Paré hospital, APHP
Boulogne-Billancourt, 92100, France
Location status: Recruiting
NCT Number: NCT04576429
The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boulogne-Billancourt, 92100, France
Location status: Recruiting
This study will analyse the association of biomarkers with relapse- or progression-free survival of stage III or IV melanoma patients, divided in 3 sub-cohorts:
For patients of cohort A and B1, immune profiles characteristics will be evaluated before initiation of treatment (=baseline), and at each radiological evaluation of the tumour response, up to maximum 12 months as duration.
The maximal duration of treatment will be 12 months for patients treated in the adjuvant setting. For metastatic patients, the duration of treatment will be decided by physician according to different factors (responses, progression, toxicities, ...).
For patients in cohort B2, the characteristics of the immune profiles will be evaluated before radiotherapy initiation,, within 6 weeks after the end of radiotherapy, then at the 2 following radiological evaluations of the tumour response
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Venous punctures will be performed:
for patients of cohort A and B1:
for patients of cohort B2:
Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.
Time frame: at 5 years
Will be noted: all progression and event of death. Survival rate will be calculated between the event's day and the beginning of anticancer treatment.
Time frame: quarterly up to 12 months
ELISA Multiplex method will be used to analyse inflammatory human cytokines in plasma. This method will performe an assay 45-plex fixed panel :
Analytes Included in the Assay
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma
Acronym: EPITHEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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