RECRUITING

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

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Conditions

Breast Neoplasm FemaleBreast cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)

Quick Facts

Study Start:2018-04-26
Study Completion:2030-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03524430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sanaa Noubir, PhD
CONTACT
1-416-333-2931
snoubir@rnadiagnostics.com
John Connolly
CONTACT
1-416-985-4361
jconnolly@rnadiagnostics.com

Principal Investigator

Maureen Trudeau, MD
PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Center, Toronto, Canada
Daniele Generali, MD
PRINCIPAL_INVESTIGATOR
SST di Cremona Multidisciplinare di Patologia Mammaria, Italy
Foluso Ademuyiwa, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine, St Louis, USA
Thierry Petit, MD
PRINCIPAL_INVESTIGATOR
Institut de Cancérologie, Strasbourg, France
Joke Tio, MD
PRINCIPAL_INVESTIGATOR
Munster, Germany
Eva Ciruelos, MD
PRINCIPAL_INVESTIGATOR
Madrid, Spain
Tomasz Jankowski, MD
PRINCIPAL_INVESTIGATOR
NZOZ Neuromed, Lublin, Poland

Study Locations (Sites)

Siteman Cancer Center
Saint Louis, Missouri, 63129
United States

Collaborators and Investigators

Sponsor: Rna Diagnostics Inc.

  • Maureen Trudeau, MD, PRINCIPAL_INVESTIGATOR, Sunnybrook Health Sciences Center, Toronto, Canada
  • Daniele Generali, MD, PRINCIPAL_INVESTIGATOR, SST di Cremona Multidisciplinare di Patologia Mammaria, Italy
  • Foluso Ademuyiwa, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine, St Louis, USA
  • Thierry Petit, MD, PRINCIPAL_INVESTIGATOR, Institut de Cancérologie, Strasbourg, France
  • Joke Tio, MD, PRINCIPAL_INVESTIGATOR, Munster, Germany
  • Eva Ciruelos, MD, PRINCIPAL_INVESTIGATOR, Madrid, Spain
  • Tomasz Jankowski, MD, PRINCIPAL_INVESTIGATOR, NZOZ Neuromed, Lublin, Poland

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-04-26
Study Completion Date2030-03-31

Study Record Updates

Study Start Date2018-04-26
Study Completion Date2030-03-31

Terms related to this study

Keywords Provided by Researchers

  • Breast cancer

Additional Relevant MeSH Terms

  • Breast Neoplasm Female