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Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer (REaCT-Algorith)

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ClinicalTrials.gov Identifier: NCT04131933
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage breast cancer. These range from free and publicly available mathematical algorithms, through to expensive genomic tests. It is not known how the use of these different scores affects physician decision making with respect to ordering genomic tests, nor how well these algorithms predict for the results of Oncotype DX ® in the real-world setting. This pragmatic study will help to answer these questions.

Condition or disease
Breast Cancer

Detailed Description:

A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage hormone receptor positive, Her2 negative breast cancer. These range from free and publicly available mathematical algorithms (e.g. NHS Predict, Magee formulae, Gage and Tennessee equations) that incorporate standard pathology results, through to expensive genomic tests (e.g. Oncotype DX ® and Endopredict ®). It is not known how the use of these different scores affects physician decision making with respect to ordering genomic tests, nor how well these algorithms predict for the results of Oncotype DX ® in the real-world setting. This pragmatic study will help to answer these questions.

In summary: Month 1 to 3: pathology and chemotherapy data is collected, no physician questionnaires given. Month 4 to 6: pathology and chemotherapy data collected, plus physician questionnaire administered. Intervention teaching after 6 months of study activation. Month 7 to 9: pathology and chemotherapy data collected, PREDICT 2.1 tool used, no physician questionnaire given. Month 10 to 12: pathology and chemotherapy data collected, PREDICT 2.1 tool used, plus physician questionnaire administered.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-centre, Prospective, Observational Study Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Rate of requests for Oncotype DX testing [ Time Frame: 12 Months ]
    To assess whether providing individual patient prognostic and predictive scores from PREDICT 2.1 affects the rate of subsequent requests for Oncotype DX ® testing. This will be the proportion of patients for which Oncotype DX ® is ordered, defined as the number of patients with Oncotype DX ® ordered divided by the number of patients eligible for Oncotype DX ® testing.


Secondary Outcome Measures :
  1. Routine availability of PREDICT 2.1 [ Time Frame: 12 Months ]
    To assess whether routine availability of PREDICT 2.1 affects adjuvant treatment (chemotherapy, radiation therapy and endocrine therapy). This will be done by identifying the time to starting chemotherapy, endocrine therapy or radiation therapy.

  2. Oncotype DX ® cost [ Time Frame: 12 Months ]
    Prognostic risk scores, including Magee formulae, Gage and Tennessee equations will be calculated using patient and tumour characteristics. These scores will be compared with Oncotype DX ® scores when performed. These will be used to determine Oncotype DX ® cost and total health system costs and subsequent health care utilization.

  3. Physician survey [ Time Frame: 3 months and 9 months ]
    A physician survey will be used to assess physician comfort when making systemic therapy decisions.It will determine whether the routine availability of PREDICT 2.1 score in the clinic enhanced their comfort with systemic therapy decision-making.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that are eligible for Oncotype DX ® testing under current funding parameters with complete pathology reports for newly diagnosed early stage breast cancer will be eligible for this prospective trial.
Criteria

Inclusion Criteria:

  • Histologically confirmed primary breast cancer
  • No prior chemotherapy
  • Eligible for Oncotype DX ® testing as per current Ontario funding criteria including: ER positive, PR positive or negative, HER2 negative, lymph node status negative or micro-invasive disease, tumor >1 cm in size (or if equal or <1 cm, must be grade 2/3 or have lymph node micrometastasis).

Exclusion Criteria:

  • Neoadjuvant treatment including window of opportunity trials
  • Recurrent breast cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131933


Contacts
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Contact: Lisa Vandermeer 613-737-7700 ext 73039 lvandermeer@toh.ca
Contact: Deanna Saunders 613-737-7700 ext 79425 cstober@toh.ca

Locations
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Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada
Contact: Lisa Vandermeer    613-737-7700 ext 73039    lvandermeer@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Arif Awan, MD Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04131933    
Other Study ID Numbers: REaCT-Algorithm
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Predict 2.1
Oncotype DX
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases