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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
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Institut Curie

Brief Summary:
Feasibility study for a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma, and quantification of CD8+ T cells specific for these tumor neo-antigens in their lymph nodes

Condition or disease Intervention/treatment Phase
Breast Cancer Cutaneous Melanoma Procedure: Blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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


Arm Intervention/treatment
Blood sampling Procedure: Blood sampling
After inclusion in the protocol, a blood sample (50 mL in EDTA tubes) will be withdrawn during pre-operative consultation.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Quantification of CD4+ T lymphocytes specific for identified tumor neo-antigens in the lymph nodes. [ Time Frame: up to 24 months ]
  2. Quantification of CD4+ and CD8+ T lymphocytes specific for identified neo-antigens in the blood and tumor. [ Time Frame: up to 24 months ]
  3. 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 ....).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients over 18 years Patient with HR+ , HER2- and node-positive (proven by cytology) invasive ductal carcinoma breast cancer, grade (SBR) II or III, and having an axillary dissection programmed, Or patient having cutaneous melanoma scheduled for a lymph node dissection at the Institut Curie including dissection of the lymph nodes draining the tumor, Voluntary having signed and dated written informed consents prior to any specific study procedure,

Exclusion Criteria:

Patients treated for a breast cancer who received neoadjuvant chemotherapy Patients treated for breast cancer with distant metastases (M+)• Only for patients with breast cancer: oral or systemic corticosteroids treatment received within 30 days prior surgery Patients on immunosuppressive treatment or diagnosed of an immunodeficiency Patients with known chronic viral infection as HIV1 or 2, HBV, HCV Patients with other cancer diagnosed within 5 years (except squamous cell cutaneous carcinomas) Patients without a French social security Patients deprived of liberty or placed under the authority of a tutor


Information from the National Library of Medicine

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


Locations
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France
Institut Curie
Paris, France, 75005
Sponsors and Collaborators
Institut Curie
Genentech, Inc.

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02831634    
Other Study ID Numbers: IC 2015-06 NeoEpitope
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Keywords provided by Institut Curie:
Breast cancer
cutaneous melanoma
Additional relevant MeSH terms:
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Melanoma
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas