Status:
UNKNOWN
Impact of Low Muscle Mass in HNC Treated With Immunotherapy
Lead Sponsor:
Institut Català d'Oncologia
Collaborating Sponsors:
Department of Health, Generalitat de Catalunya
Conditions:
Head and Neck Small Cell Carcinoma
Sarcopenia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the study is to evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the n...
Detailed Description
Body composition including sarcopenia (loss of muscle mass), sarcopenic obesity, and mioesteaosis has been well reported to be an independent predictors of mortality, toxicity, and complications in ca...
Eligibility Criteria
Inclusion
- Patients diagnosed with recurrence or metastatic SCCHN treated with antiPDL1, antiPD1 or antiCTLA-4 drugs, alone or in combination within our institution.
- Patients who have previously signed informed consent.
- Patients with measurable tumor lesions.
Exclusion
- Patients with non-measurable lesions.
- Patients who do not sign the informed consent.
- Patients not treated with immunotherapy.
- Patients in a double-blind trial in whom the assigned branch is not known.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04721184
Start Date
January 20 2021
End Date
August 1 2024
Last Update
January 22 2021
Active Locations (1)
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1
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain, 08908