An observational study in Breast Cancer, sponsored by Precise Dx, Inc.. Not yet recruiting. Open to female participants aged 23 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Precise Dx, Inc. · Observational
The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC.
Female breast cancer (BC) has surpassed lung cancer as the most commonly diagnosed cancer worldwide, which translates into 24.5% of all cancer diagnoses and 15.5% of all cancer death. In the United States, it is estimated that 290,560 Americans will be diagnosed with breast cancer in 2022 and 43,780 will die of disease. Given these statistics, the 2022 National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and College of American Pathologists (CAP) clinical practice guidelines continue to stress the critical importance of the pathology assessment at diagnosis to establish extent of disease and features that reflect a biological potential for recurrence such as histologic grade and stage.
Precise Dx Breast Assay (PDxBR™) is an in vitro prognostic clinically approved test by the NYSDOH to predict breast cancer recurrence for patients diagnosed with early-stage IBC. The test utilizes a digital scan of a representative H\&E-stained resection specimen from the patient. Using advances in applied artificial intelligence (AI) outcome-based image analysis, selected features of the invasive cancer are acquired and combined with clinical variables to produce a risk score predicting likelihood of having breast cancer recurrence within 6-years. With the advent of computational methods, the investigator's investigated whether AI interrogation of whole slide images (WSI) could be used to improve on the characterization and accuracy of IBC histopathology. The approach was based on the generation of quantitative, discreet morphology features within a tissue section (Morphology Feature Array, MFA) and the use of machine learning to create AI models that predict risk of recurrence in early-stage disease. The investigator's developed a test that improves risk stratification of IBC relative to the use of clinical features as well as re-classification of standard breast histologic grade into low- and high-risk groups using MFA-enabled AI models.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 300 is above the median of 184 across 2,643 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Precise Dx, Inc. as lead sponsor.
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Accepting all patients newly diagnosed with early stage breast cancer and scheduled for a resection.
Exclusion Criteria:
Patients with a diagnosis of early-stage invasive breast cancer, post-surgery, in the process of developing a treatment plan. After a period of 2-4 weeks, patient and provider will receive the PreciseDx breast test results with follow up questionnaires to assess change in care path.
Other: Standard of Care
Patients with a diagnosis of early-stage invasive breast cancer, post-surgery, in the process of developing a treatment plan. In addition to standard of care the patient and their provider will also receive the results from the PreciseDx breast test. Questionnaires will be utilized to assess impact on decision making and planned care path.
Other: Standard of Care
To use the patients age, tumor size, grade, and lymph node status and any genomic tests (i.e. OncotypeDx, MammaPrint etc to determine risk of recurrence,
Decision Impact Study of PreciseDx Breast on treating Oncologist
Proportion (target; 20%) of medical oncologists who utilized the PDxBR results in their management of patients with IBC including any of the following decisions / actions: i. overall confirmation or adjustment of original management plan, ii. order / defer genomic testing, iii. adjust type, dose, or regimen of endocrine therapy, iv. introduction of chemotherapy in addition to endocrine treatment, v. use radiotherapy etc.
Time frame: 6-12 months
Decision Impact Study of PreciseDx Breast on Diagnostic Pathologist
Proportion (target: 20%) of pathologists who utilized the PDxBR results in their routine diagnostic assessment of IBC including any of the following: i. supported and or changed their diagnostic histologic grade (based on the AI-grade provided by the PDxBR assay), ii. provided additional useful information in the histologic assessment of the IBC including the presence of lymphocytes, stromal content etc. iii. found the interactive smart phone accessible digital feature display tool helpful in their understanding and use of the test results in their assessment process.
Time frame: 6-12 months
Decision Impact on long term outcomes
Use of NPV, PPV, Sensitivity, Specificity, HR for predicting local-regional, distant metastasis or overall survival.
Time frame: 2-5 years
No study locations are listed for this record.
Plan to share: Undecided — Currently there is no plan to make IPD available to other researchers. As this is a multi-site study - depending on patient. numbers - we will collectively evaluate impact on decision making.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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