Core needle biopsy for Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neoplasms+1 More
Core needle biopsy - Procedure
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial validates the RNA Disruption Assay as a tool to measure tumor response to neoadjuvant chemotherapy, using biopsies taken 35 days after treatment starts.

Eligible Conditions
  • Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 5 years of survival follow-up

Year 5
Disease-free survival
At surgery
Residual Cancer Burden
At surgery after completion of neoadjuvant therapy
Pathological complete response (pCR)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Single Interventional Study Arm
1 of 1
Experimental Treatment

594 Total Participants · 1 Treatment Group

Primary Treatment: Core needle biopsy · No Placebo Group · N/A

Single Interventional Study Arm
Procedure
Experimental Group · 1 Intervention: Core needle biopsy · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years of survival follow-up

Who is running the clinical trial?

Rna Diagnostics Inc.Lead Sponsor
Foluso Ademuyiwa, MDPrincipal InvestigatorWashington University School of Medicine, St Louis, USA
Daniele Generali, MDPrincipal InvestigatorSST di Cremona Multidisciplinare di Patologia Mammaria, Italy
1 Previous Clinical Trials
190 Total Patients Enrolled
Maureen Trudeau, MDPrincipal InvestigatorSunnybrook Health Sciences Center, Toronto, Canada
1 Previous Clinical Trials
123 Total Patients Enrolled
Joke TioPrincipal InvestigatorMunster, Germany
Thierry Petit, MDPrincipal InvestigatorInstitut de Cancérologie, Strasbourg, France
Joke Tio, MDPrincipal InvestigatorMunster, Germany
Eva Ciruelos, MDPrincipal InvestigatorMadrid, Spain
3 Previous Clinical Trials
422 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Breast cancer must be confirmed by histological examination.
Patient is scheduled for neoadjuvant chemotherapy +/- antibodies and +/- other drugs according to Standard of Care.
You are willing to have 2 core needle biopsies taken at 2 collection timepoints during neoadjuvant chemotherapy treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References