Clinical trial · Interventional
A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes (NeoEpitope)
A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes
NCT02831634CI-TRIAL-00094726NeoEpitopecompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Blood sampling
- interventionNames
- Procedure: Blood sampling
Primary outcomes (1)
- measure
- 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.
- timeFrame
- up to 24 months
- description
- 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 outcomes (3)
- measure
- Quantification of CD4+ T lymphocytes specific for identified tumor neo-antigens in the lymph nodes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.