An interventional study of Biological samples in Lung Cancer, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other
Increasing evidence suggests that immune responses might be a determining factor in lung cancer tumor progression.
The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response is required for their efficacy and highlight the critical role of antitumor T cell immunity. Recent progress on the fields of tumor immunology underlines the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.
In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators group have previously described novel promiscuous peptides (referred as UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.
By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this response were inversely correlate to the disease stage. Furthermore, UCP-specific responses were significantly found in patients with low PD1+ and TIM3+ T cells.
Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer before and after treatment (chemotherapy, immunotherapy).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 321 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 438 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Blood samples will be collected at baseline, after the first-line therapy and at 12 months. Tumor tissues will be collected if available.
Other: Biological samples
blood and tumor tissue samples
overall survival
time between the date of initiation of treatment and the date of death from any cause
Time frame: date of death from any cause (within 2 years after the initiation of the treatment)
UCP-specific Th1 responses measured by ELISPOT assay
Time frame: up to 12 months
Progression free survival
time interval between the date of initiation of treatment and the date of first progression (local, remote \[extent of the disease by RECIST v1.1\] second cancer) or death from any cause.
Time frame: date of first progression of the disease (within 2 years after the initiation of the treatment)
quality of life related to health measured by EORTC-QLQC30 and LC13 questionaries.
Time frame: from the inclusion to patient death, up to 2 years
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire de Besancon