Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033
Location status: Recruiting
Location contact
Mickaël BURGY
CONTACT
Mickaël BURGY
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05328024
This project aims to organise the sampling of blood and tumor at key points of the standard of care of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC). This will allow to identify new potential predictive biomarkers of efficacy of immunotherapy and to investigate the evolution of the tumoral microenvironment after successive systemic treatments.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Strasbourg, France, 67033
Location status: Recruiting
Mickaël BURGY
CONTACT
Mickaël BURGY
PRINCIPAL_INVESTIGATOR
Tumor and blood samples will be collected on patients treated by anti-PD1 immunotherapy at different timepoints. Tumor samples will be collected (i) before initiation of immunotherapy, (ii) at 50 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at 50 days after initiation of chemotherapy. Blood samples will be collected : (i) before initiation of immunotherapy, (ii) at each cycles of treatment until 84 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at each cycle until 50 days after initiation of chemotherapy (maximum 2 samples per month).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
anti-PD1
Time frame: at 3 months after initiation of immunotherapy
objective response according to RECIST v1.1 (response evaluation criteria in solid tumours)
Time frame: at 3 months after initiation of immunotherapy
objective response according to iRECIST criteria (immune response evaluation criteria in solid tumours)
Time frame: at 3 years after inclusion
Time from date of inclusion to the event of tumor recurrence or clinical progression or radiological progression on primary tumor or on lymph nodes or on metastasis or death whatever the cause.
Time frame: at 3 years after inclusion
Time from date of inclusion to death whatever the cause.
Time frame: at 3 years after inclusion
Time from date of first observation of objective response to progressive disease according to RECIST v1.1 or death..
Time frame: at 3 months after initiation of immunotherapy
objective response according to RECIST v1.1
Time frame: at 3 months after initiation of immunotherapy
objective response according to RECIST v1.1
Time frame: at 3 months after initiation of immunotherapy
objective response according to RECIST v1.1
Time frame: at 3 months after initiation of immunotherapy
objective response according to RECIST v1.1
Contact information is provided by the study sponsor or research team.
Manon VOEGELIN
CONTACT
Valérie SARTORI
CONTACT
Centre Paul Strauss
Other
Acronym: IPRICE
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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