Clinical biomarker for early prediction of chemotherapy-induced peripheral neuropathy

早期预测化疗引起的周围神经病变的临床生物标志物

• 批准号: 10604018
• 负责人: Simon Haroutounian
• 金额: $ 40.32万
• 依托单位: NEWVENTUREIQ, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10604018
• 关键词: Acute; Adherence; Adoption; Affect; Agreement; Algorithms; Analgesics; Antineoplastic Agents; Architecture; Area; Biological Markers; Biopsy; Cancer Patient; Cancer Survivor; Caring; Characteristics; Chemotherapy-induced peripheral neuropathy; Chronic; Clinical; Clinical Trials; Colorectal; Colorectal Cancer; Communication; Complication; Data; Data Collection; Data Reporting; Data Set; Data Storage and Retrieval; Development; Devices; Dose; Dose Limiting; Early identification; Environment; Equipment; Feedback; Frequencies; Goals; Hand; Health Technology; Health system; Home; Hypersensitivity; Hypersensitivity skin testing; Impairment; Individual; Intervention; Interview; Legal patent; Life; Logic; Malignant neoplasm of gastrointestinal tract; Measures; Medical Device; Metals; Methods; Morbidity - disease rate; Neural Conduction; Opioid; Outcome; Pain; Paper; Patient Self-Report; Patient risk; Patient-Centered Care; Patient-Focused Outcomes; Patients; Performance; Pharmaceutical Preparations; Phase; Prevention; Prospective Studies; Quality of life; ROC Curve; Regimen; Reporting; Resource-limited setting; Resources; Risk; Rod; Schedule; Self Assessment; Sensitivity and Specificity; Skin; Small Business Technology Transfer Research; System; Technology; Temperature; Testing; Universities; Validation; Washington; chemotherapy; clinical biomarkers; clinical decision support; clinical decision-making; colorectal cancer treatment; commercial application; commercialization; compliance behavior; cost; data management; digital health; duloxetine; early detection biomarkers; implementation barriers; implementation evaluation; improved; mHealth; mobile application; novel; opioid use; oxaliplatin; pain symptom; patient stratification; prediction algorithm; predictive marker; prescription opioid; prevent; prospective; prototype; public health relevance; risk prediction; risk stratification; shared decision making; side effect; success; symptomatic improvement; technological innovation; tool; usability; user centered design

Project Summary / Abstract Chemotherapy induced peripheral neuropathy (CIPN) is a major side effect of oxaliplatin, a key drug in 1st line regimens for treating colorectal cancer. Dose-limiting CIPN prevents >25% of patients from receiving full, maximally effective dose of oxaliplatin. In addition, 10-40% of patients receiving oxaliplatin-based therapy for colorectal cancer with develop chronic CIPN, which is painful, impairs quality of life, and is associated with higher opioid use rates. Approaches for CIPN prevention have not yielded meaningful success. A biomarker that can help with early prediction of CIPN will be a major facilitator of shared decision making (i.e. changing chemotherapy intensity, frequency, or type) to prevent CIPN, and in stratifying patients to targeted clinical trials for CIPN prevention. To that end, we have recently characterized the Allo-ColdTM method for early prediction of CIPN, based on dynamic quantification of cold hypersensitivity. In preliminary studies, the method demonstrated promising sensitivity and specificity. It is non-invasive, scalable, and has a potential to be readily implementable, including in low-resource settings. Our main goal for this Phase I STTR proposal is to develop and test a user-centered mobile health system prototype for collecting, storing, aggregating and processing patient-reported data on palmar cold sensitivity to predict CIPN. In Aim 1, we will develop the Allo-Cold mobile health technology prototype using a user-centered design approach. We will use three-tier architecture to develop the patient user interface, data management and storage, and data logic components of a mobile app for CIPN risk prediction. We will iteratively test and refine the prototype. We will conduct interviews with cancer patients for feedback on prototype acceptability, and with clinicians to assess implementation barriers. In Aim 2, we will demonstrate adherence and predictive performance of Allo-Cold system in patients undergoing oxaliplatin-based chemotherapy. Twenty-four patients with stage III/IV colorectal cancer undergoing oxaliplatin-based therapy will use Allo-Cold, and self-report cold pain and cold unpleasantness daily for 10 weeks (5 cycles) of chemotherapy. We will determine patient adherence and the performance of our predictive algorithm in predicting dose-limiting CIPN. In this Phase I STTR proposal, we expect to determine the feasibility of the Allo-Cold system by confirming its usability, adherence, and predictive performance in the context of oxaliplatin-based therapy for colorectal cancer. Phase II STTR proposal will focus on completing full clinical and analytical validation of Allo-Cold as a predictive biomarker for CIPN, toward FDA approval and subsequent commercialization.

项目摘要/摘要