Clinical trial · Observational

Decision Impact Study of PreciseDx Breast

Prospective Clinical Utility / Decision Support Study of an AI-enabled Digital Breast Cancer Test (Precise Dx Breast, PDxBRTM) to Predict Early-stage Breast Cancer Recurrence Within 6 Years

NCT06309615CI-TRIAL-00090301PDxBRUTILITYnot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Standard of Care	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Standard of Care
description
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.
interventionNames
1. Other: Standard of Care
label
Standard of Care plus PreciseDx Breast test
description
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.
interventionNames
1. Other: Standard of Care

Primary outcomes (2)

measure
Decision Impact Study of PreciseDx Breast on treating Oncologist

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 23 Years

Show eligibility criteria text

Inclusion Criteria:

* Invasive breast cancer (ductal / mixed ductal-lobular)

Exclusion Criteria:

* Prior history of invasive breast cancer
* Neoadjuvant therapy

References

Publications (2)

BACKGROUNDFernandez G, Zeineh J, Prastawa M, Scott R, Madduri AS, Shtabsky A, Jaffer S, Feliz A, Veremis B, Mejias JC, Charytonowicz E, Gladoun N, Koll G, Cruz K, Malinowski D, Donovan MJ. Analytical Validation of the PreciseDx Digital Prognostic Breast Cancer Test in Early-Stage Breast Cancer. Clin Breast Cancer. 2024 Feb;24(2):93-102.e6. doi: 10.1016/j.clbc.2023.10.008. Epub 2023 Nov 2. PMID 38114366
RESULTFernandez G, Prastawa M, Madduri AS, Scott R, Marami B, Shpalensky N, Cascetta K, Sawyer M, Chan M, Koll G, Shtabsky A, Feliz A, Hansen T, Veremis B, Cordon-Cardo C, Zeineh J, Donovan MJ. Development and validation of an AI-enabled digital breast cancer assay to predict early-stage breast cancer recurrence within 6 years. Breast Cancer Res. 2022 Dec 20;24(1):93. doi: 10.1186/s13058-022-01592-2. PMID 36539895