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RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy

NCT03524430 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 801

Last updated 2025-10-14

No results posted yet for this study

Summary

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

  • Breast Neoplasm Female

Interventions

PROCEDURE

Core needle biopsy

1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/-4 days after initiation of chemotherapy. If no change is made to the therapy, a second biopsy (2 specimens) will be performed at 55 +/- 5 days after therapy initiation. If there is a change of drugs, the second biopsy (2 specimens) will be performed at \~2-3 weeks after initiation of new drugs; Timing by type of drug schedule 3-weekly: at 16 days +/- 2 days, Bi-weekly: at day of 2nd dose preferably before drug admin., Weekly: at day of 4th dose preferably before drug admin.

Sponsors & Collaborators

  • Rna Diagnostics Inc.

    lead INDUSTRY

Principal Investigators

  • Maureen Trudeau, MD · Sunnybrook Health Sciences Center, Toronto, Canada

  • Daniele Generali, MD · SST di Cremona Multidisciplinare di Patologia Mammaria, Italy

  • Foluso Ademuyiwa, MD · Washington University School of Medicine, St Louis, USA

  • Thierry Petit, MD · Institut de Cancérologie, Strasbourg, France

  • Joke Tio, MD · Munster, Germany

  • Eva Ciruelos, MD · Madrid, Spain

  • Tomasz Jankowski, MD · NZOZ Neuromed, Lublin, Poland

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2026-07-30
Completion
2031-03-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03524430 on ClinicalTrials.gov