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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-09

Study Completion Date

2018-03-01

Brief Summary

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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

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Detailed Description

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Conditions

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Breast Cancer Cutaneous Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Blood sampling

Group Type OTHER

Blood sampling

Intervention Type PROCEDURE

After inclusion in the protocol, a blood sample (50 mL in EDTA tubes) will be withdrawn during pre-operative consultation.

Interventions

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Blood sampling

After inclusion in the protocol, a blood sample (50 mL in EDTA tubes) will be withdrawn during pre-operative consultation.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No