Actively Recruiting
RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
Led by Rna Diagnostics Inc. · Updated on 2025-10-14
801
Participants Needed
7
Research Sites
674 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.
CONDITIONS
Official Title
RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged at least 18 years
- Able to provide informed consent before any study procedures
- Newly diagnosed clinical stage I, II, or III breast cancer with goal of complete surgical removal after neoadjuvant therapy
- Tumor size at least 1 cm in one dimension by clinical or radiographic exam
- Histological confirmation of invasive breast cancer of any subtype or grade
- Scheduled for neoadjuvant chemotherapy with or without antibodies or other drugs per standard care
- Willing to have two research core needle biopsies taken during neoadjuvant chemotherapy treatment
You will not qualify if you...
- Prior local (surgery or radiotherapy) or systemic (endocrine or cytotoxic) therapy for current breast cancer
- Participation in another interventional clinical trial with experimental treatments for current breast cancer during neoadjuvant therapy
- Stage IV breast cancer
- Bilateral or multicentric breast tumor
- Prior malignant disease except curatively treated in-situ malignancies
- Current pregnancy
- Breastfeeding
- Medical, psychiatric, or addictive disorders limiting consent or trial completion
- Risk factors for poor compliance with study procedures
- Unable to provide informed consent
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Siteman Cancer Center
St Louis, Missouri, United States, 63129
Actively Recruiting
2
Sunnybrook Health Sciences Center
Toronto, Canada
Actively Recruiting
3
Institut de Cancerologie de Strasbourg
Strasbourg, France
Actively Recruiting
4
Universitätsklinikum Münster
Münster, Germany
Actively Recruiting
5
SST di Cremona Multidisciplinare di Patologia Mammaria, Italy
Cremona, Italy
Actively Recruiting
6
NZOZ Neuromed
Lublin, Poland
Actively Recruiting
7
Hospital U. 12 de Octubre
Madrid, Spain
Actively Recruiting
Research Team
S
Sanaa Noubir, PhD
CONTACT
J
John Connolly
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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