A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes (NeoEpitope)

Not Applicable

Completed

• Conditions: Cutaneous Melanoma; Breast Cancer
• Interventions: Procedure: Blood sampling

• Registration Number: NCT02831634
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-09
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sampling	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
Quantification of CD4+ T lymphocytes specific for identified tumor neo-antigens in the lymph nodes.	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.	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 ....).
Quantification of CD4+ and CD8+ T lymphocytes specific for identified neo-antigens in the blood and tumor.	up to 24 months

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France