A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes (NeoEpitope)
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|ClinicalTrials.gov Identifier: NCT02831634|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cutaneous Melanoma||Procedure: Blood sampling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes|
|Actual Study Start Date :||June 9, 2016|
|Actual Primary Completion Date :||March 1, 2018|
|Actual Study Completion Date :||March 1, 2018|
Procedure: Blood sampling
After inclusion in the protocol, a blood sample (50 mL in EDTA tubes) will be withdrawn during pre-operative consultation.
- Feasibility of a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma and quantification of CD8+ T cells specific for the tumor neo-antigens identified in the lymph nodes. [ Time Frame: up to 24 months ]Feasibility study for a method allowing identification of tumor mutated epitopes : Identification of MHC cl I and II restricted tumor neo-epitopes by two different methods i.e. by an elution-HPLC method performed on cell lines derived from tumor cells obtained from invaded lymph node, or using predictive algorithms on tumor sequencing data.
- Quantification of CD4+ T lymphocytes specific for identified tumor neo-antigens in the lymph nodes. [ Time Frame: up to 24 months ]
- Quantification of CD4+ and CD8+ T lymphocytes specific for identified neo-antigens in the blood and tumor. [ Time Frame: up to 24 months ]
- Comparison of the frequency and relative amplitude of the T cell response specific for the tumor neo-epitopes with other immune responses and responses against known tumor antigens. [ Time Frame: up to 24 months ]Comparison of the frequency and relative amplitude of the T cell response specific for the tumor neo-epitopes with other immune responses such as anti-viral memory responses (influenza A, ...), chronic viral responses (cytomegalovirus [CMV] Epstein-Barr virus [EBV], ...) and responses against known tumor antigens (such as NY-ESO-1, MAGE-A3, p53, gp100 ....).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831634
|Paris, France, 75005|