R21CA268428

Adapting a machine learning algorithm to predict thyroid cytopathology in LMIC - Abstract

Pathology expertise and services in low and middle income countries (LMIC) are severely inadequate and limited. One area in which pathology is especially critical for diagnosis and clinical decision making is thyroid related disease and cancers. The incidences of thyroid nodules and cancers have increased worldwide.

A fundamental part of the clinical assessment for thyroid nodules is ultrasound-guided fine needle aspiration biopsy (FNAB). Unfortunately, this cytopathology expertise is scarce in LMIC and many nodules are surgically removed for diagnosis. Since 90-95% of these nodules are without malignancy, many patients undergo unnecessary surgery with the associated risks, financial costs, and stressing already limited resources.

What is critically needed is a means to provide cytopathology expertise to interpret thyroid FNAB in LMIC. The overall goal of this proposal is to implement our ML approach into low resource settings to provide accurate and timely cytopathology analysis of FNAB specimens.

This R21/33 proposal focuses on MLA adaptation using smartphones for LMIC (R21) and subsequent capacity building and implementation (R33) through well-established LMIC research partnerships in tertiary centers in Tanzania and Vietnam.

We hypothesize that our MLA can use smartphone captured images to assess probability of malignancy in thyroid FNAB that is comparable to trained cytopathologists. Our aims are:

R21: Adaptation of a smartphone approach to capture cytopathology images for MLA analysis. Archived FNAB samples used at different international institutions will be used to train and adapt the MLA with these images. Furthermore, we would train local personnel in LMIC to image capture using this new setup. The results from this phase will be an adapted MLA using smartphone images that has comparable sensitivity and specificity to the original MLA.

R33: Implementation of the smartphone MLA approach into LMIC clinical settings. A prospective implementation of this approach in tertiary centers in Tanzania and Vietnam will be conducted. FNAB samples obtained would undergo standard of care pathology assessment as well as be analyzed with the MLA protocol. Local cytopathologist assessment will be compared with the MLA analysis. Outcome measures include MLA assessment of slides, technical slide review and image capture, concordance with pathology between MLA and expertise both in US and LMIC.

The expected outcome will lead to a cost-effective method to implement MLA for thyroid FNAB that can be used in LMIC. This approach will not only assist in early diagnosis of thyroid cancers but also improve the utilization of limited resources through effectively identifying those that need surgery from those that do not.

Duke University

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

Durham, North Carolina 27710 United States

Single Zip Code

Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional) (PAR-19-376)

Amendment Since initial award the End Date has been extended from 07/31/23 to 07/31/24 and the total obligations have increased 38710% from $1,000 to $388,100.