Single-cell RNAseq Breast Cancer

NCT05807516 | Unknown

• 1 other identifier: RS1637/21
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Molecular characterization of persistent tumor cells remaining after NAC and infiltrating immune cells, for example, M2 macrophages, could strongly contribute to identifying targeted therapeutic approaches for this disease.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Evaluate chemoterapy effect

  Decipher, through the execution of scRNAseq profiles, the transcriptional reprogramming that occurs during chemotherapy (NAC) in triple negative breast cancers (TNBC) and provide information of prognostic and/or predictive relevance of response to NAC

  26 months

Interventions

Single-cell RNA sequencing (scRNAseq), whole-exome sequencing (WES) OTHER

Combined both retrospective and prospective observational design

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The retrospective study will be performed using only formalin-fixed paraffin-embedded (FFPE) tissue samples for protein expression profiling (proteomics) from patients withthe above inclusion/exclusion criteria from the archives of the Pathological anatomy of the IRE. The prospective study foresees the collection of biological samples by the centers involved in the study and the freezing of all the samples at the IRE Biological Bank.

You may qualify if:

• Patients with histologically proven primary invasive breast cancer \>1.5cm in size, with molecular assessed stage IIA to IIIB defined as TNBC, and who will undergo neoadjuvant chemotherapy and subsequent surgery (and/or have undergone - retrospective part).
• informed consent (prospective part)

You may not qualify if:

• pregnancy, metastatic breast cancer, previous chemotherapy, hormone therapy, radiation therapy, previous other cancers or contralateral breast cancer

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (2)

Policlinico Umberto I

Roma, 00161, Italy

RECRUITING

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Single-Cell Gene Expression Analysis; Exome

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Single-Cell Analysis; Cytological Techniques; Investigative Techniques; Gene Expression Profiling; Genetic Techniques; Genome; Genetic Structures; Genetic Phenomena

Central Study Contacts

Giovanni Blandino

CONTACT

+39 06 52662911; giovanni.blandino@ifo.gov.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: December 14, 2021
• Primary Completion: December 12, 2022
• Study Completion: December 31, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-03

Locations

IT (2)