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

NCT02831634 | Completed

• 1 other identifier: IC 2015-06
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Cutaneous Melanoma

Keywords

Breast cancer; cutaneous melanoma

Outcome Measures

Primary Outcomes (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.

  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.

  up to 24 months

Secondary Outcomes (3)

• Quantification of CD4+ T lymphocytes specific for identified tumor neo-antigens in the lymph nodes.

  up to 24 months

• Quantification of CD4+ and CD8+ T lymphocytes specific for identified neo-antigens in the blood and tumor.

  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

Study Arms (1)

Blood sampling

OTHER

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

After inclusion in the protocol, a blood sample (50 mL in EDTA tubes) will be withdrawn during pre-operative consultation.

Blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 13, 2016
• Study Start: June 9, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 8, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (1)