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Study of Tumor RNA Disruption Assay™ (RDA) (RnaDx)

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ClinicalTrials.gov Identifier: NCT02239315
Recruitment Status : Terminated (Lack of funding)
First Posted : September 12, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Murray Krahn, University of Toronto

Tracking Information
First Submitted Date  ICMJE September 2, 2014
First Posted Date  ICMJE September 12, 2014
Last Update Posted Date October 26, 2017
Study Start Date  ICMJE December 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
The association between RDA score and pathological complete response (pCR) [ Time Frame: An expected average of 6 months ]
The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and the pCR to neoadjuvant chemotherapy will be evaluated. pCR is defined as no evidence of invasive carcinoma in the breast and lymph nodes (ypT0/Tis ypN0/N0itc) on histology at the time of surgery (lumpectomy or mastectomy).
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
The association between RDA score and pathological complete response (pCR) [ Time Frame: An expected average of 6 months ]
To evaluate an association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and pCR to neoadjuvant chemotherapy treatment. pCR is defined as no evidence of invasive carcinoma in the breast and lymph nodes (ypT0/Tis ypN0/N0itc) on histology at the time of surgery (lumpectomy or mastectomy).
Change History Complete list of historical versions of study NCT02239315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2015)
  • The prognostic ability of RDA score [ Time Frame: An expected average of 6 months ]
    The capacity of RDA score to predict pCR to neoadjuvant chemotherapy will be assessed by exploring for a cut point on the RDA score to differentiate subjects with a high likelihood of achieving pCR versus those who are less likely to achieve pCR.
  • The association between RDA score and clinical response (cR) [ Time Frame: An expected average of 6 months ]
    The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and clinical response to neoadjuvant chemotherapy treatment will be evaluated.
  • Patients' perception of fine needle aspiration biopsy (FNAB) and of breast cancer care [ Time Frame: An expected average of 12 months ]
    We shall seek to understand the experiences of patients with the FNAB procedure and with the cancer care they received while participating in the study by conducting qualitative interviews of study subjects.
  • The cost-effectiveness of using RDA score [ Time Frame: An expected average of 6 months ]
    The cost-effectiveness of using RDA score to guide neoadjuvant chemotherapy will be evaluated by measuring the cost-effectiveness of monitoring pCR to neoadjuvant chemotherapy through the RDA score and in modifying the neoadjuvant chemotherapy regimen for non-pCR patients accordingly.
  • The association between RDA score and Disease-Free Survival (DFS) [ Time Frame: An expected average of 5 years ]
    The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and DFS will be evaluated. DFS will be measured as the time from patient's enrollment to the event of cancer metastasis or recurrence, or death, whatever comes first.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
  • The prognostic ability of RDA score to predict pCR [ Time Frame: An expected average of 6 months ]
    A cut point on RDA score will be explored which will be used to differentiate subjects with a high likelihood of achieving pCR versus those who are less likely to achieve pCR, focusing on the negative predictive value (NPV). The NPV represents the proportion of subjects who do not have pCR among those predicted not to have pCR
  • The association between RDA score and clinical response (cR) [ Time Frame: An expected average of 6 months ]
    To evaluate an association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and clinical response to neoadjuvant chemotherapy treatment.
  • Patients' perception of the fine needle aspiration biopsy (FNAB) procedure and of the cancer care they received [ Time Frame: An expected average of 4 months ]
    To understand the experiences of patients with the FNAB procedure and with the cancer care they received while participating in the study by conducting qualitative interviews of study subjects.
  • The cost-effectiveness of using RDA score to guide neoadjuvant chemotherapy [ Time Frame: An expected average of 6 months ]
    To evaluate the cost-effectiveness of monitoring pCR through the RDA score in monitoring the pCR of breast cancer patients to neoadjuvant chemotherapy and in modifying the neoadjuvant chemotherapy regimen for non-pCR patients accordingly.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tumor RNA Disruption Assay™ (RDA)
Official Title  ICMJE Study of Tumor RNA Disruption Assay™ (RDA) and Its Association With a Response to Neoadjuvant Chemotherapy in Breast Cancer - A Prospective Mixed-Methods Study
Brief Summary The purpose of this study is to find out if the pathological complete response (pCR) to chemotherapy given before surgery (neoadjuvant chemotherapy) could be predicted by the evaluation of the RNA (ribonucleic acids) disruption pattern (RNA Disruption Assay or RDA score) obtained from a biopsy of the tumor 7 - 14 days after the first, second and third cycles of chemotherapy treatment. If we can determine the optimal time during neoadjuvant chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast cancer management.
Detailed Description

When administering neoadjuvant chemotherapy, the current practice of monitoring response to treatment is by measuring the size of the breast tumor after each cycle of chemotherapy. The drawback to this method is, it will take several weeks before we can actually measure a significant change in size; and the initial response to chemotherapy is often evident as a softening of the tumor without an apparent decrease of the tumor size. Finding a reliable way to identify early response to chemotherapy would be helpful to enable matching of chemotherapy to an individual's need.

In a previous trial of breast cancer treated with neoadjuvant chemotherapy, researchers have identified that the pCR to a full treatment of chemotherapy could be predicted by the change in RNA pattern obtained from a biopsy of the tumor half way through the chemotherapy course. [Parissenti et al. 2010] The purpose of this study is to determine if we can predict the pCR to neoadjuvant chemotherapy by examining the pattern of RNA disruption (RNA Disruption Assay or RDA score) from breast biopsy tissue obtained 7 to 14 days after the first, second and third cycle of chemotherapy. If we can determine the optimal time during neoadjuvant chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast cancer management. For example, if RDA score can identify non-responders earlier, we can switch to other chemotherapy agents and reduce the exposure to the unnecessary side-effects of ineffective treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Other: Tumor RNA Disruption Assay™ (RDA)
Tumor RNA Disruption Assay™ (RDA) to generate RDA score from fine needle aspiration biopsy samples of breast cancer obtained 7-14 days after the first, second and third cycles of neoadjuvant chemotherapy; and, if there is a change of chemotherapy regimen, after the first cycle of the new chemotherapy.
Other Name: Biomarker
Study Arms  ICMJE Experimental: Tumor RNA Disruption Assay™ (RDA)
Tumor RNA Disruption Assay™ (RDA) to generate RDA score from fine needle aspiration biopsy samples of breast cancer obtained 7-14 days after the first, second and third cycles of neoadjuvant chemotherapy; and, if there is a change of chemotherapy regimen, after the first cycle of the new chemotherapy.
Intervention: Other: Tumor RNA Disruption Assay™ (RDA)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 1, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2014)
220
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female,18 years or older;
  • Able to read and write in English:
  • With palpable cancer > 2cm (T2, T3) on clinical examination or clinical diagnosis of locally advanced breast cancer (LABC) (T3 or T4; or N2 or N3, according to TNM cancer staging including inflammatory breast cancer);
  • Must have histological proof of breast cancer (invasive ductal or infiltrating lobular);
  • Scheduled to receive neoadjuvant chemotherapy as part of their treatment plan;
  • Agree to have FNAB after the first, second and third cycle of chemotherapy, and if the chemotherapy regimen is changed, an additional FNAB after the first cycle of the new chemotherapy.

Exclusion Criteria:

  • Subjects who have had surgery, neoadjuvant chemotherapy or radiotherapy for the current breast cancer;
  • Subjects who are pregnant or breast feeding;
  • Subjects with Stage IV breast cancer;
  • Psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02239315
Other Study ID Numbers  ICMJE 495462
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Murray Krahn, University of Toronto
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE University Health Network, Toronto
Investigators  ICMJE
Principal Investigator: Murray Krahn, MD,MSc,FRCPC Director of THETA Collaborative, the F. Norman Hughes Chair in Pharmacoeconomics and Social and Administrative Pharmacy Division Head in the Faculty of Pharmacy, Professor at the University of Toronto
PRS Account University of Toronto
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP