Clinical biomarker for early prediction of chemotherapy-induced peripheral neuropathy
Clinical biomarker for early prediction of chemotherapy-induced peripheral neuropathy
批准号:
10604018
负责人:
Simon Haroutounian
金额:
$40.32万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-09-19 至 2025-08-31
关键词:
AcuteAdherenceAdoptionAffectAgreementAlgorithmsAnalgesicsAntineoplastic AgentsArchitectureAreaBiological MarkersBiopsyCancer PatientCancer SurvivorCaringCharacteristicsChemotherapy-induced peripheral neuropathyChronicClinicalClinical TrialsColorectalColorectal CancerCommunicationComplicationDataData CollectionData ReportingData SetData Storage and RetrievalDevelopmentDevicesDoseDose LimitingEarly identificationEnvironmentEquipmentFeedbackFrequenciesGoalsHandHealth TechnologyHealth systemHomeHypersensitivityHypersensitivity skin testingImpairmentIndividualInterventionInterviewLegal patentLifeLogicMalignant neoplasm of gastrointestinal tractMeasuresMedical DeviceMetalsMethodsMorbidity - disease rateNeural ConductionOpioidOutcomePainPaperPatient Self-ReportPatient riskPatient-Centered CarePatient-Focused OutcomesPatientsPerformancePharmaceutical PreparationsPhasePreventionProspective StudiesQuality of lifeROC CurveRegimenReportingResource-limited settingResourcesRiskRodScheduleSelf AssessmentSensitivity and SpecificitySkinSmall Business Technology Transfer ResearchSystemTechnologyTemperatureTestingUniversitiesValidationWashingtonchemotherapyclinical biomarkersclinical decision supportclinical decision-makingcolorectal cancer treatmentcommercial applicationcommercializationcompliance behaviorcostdata managementdigital healthduloxetineearly detection biomarkersimplementation barriersimplementation evaluationimprovedmHealthmobile applicationnovelopioid useoxaliplatinpain symptompatient stratificationprediction algorithmpredictive markerprescription opioidpreventprospectiveprototypepublic health relevancerisk predictionrisk stratificationshared decision makingside effectsuccesssymptomatic improvementtechnological innovationtoolusabilityuser centered design
中文摘要
项目摘要/摘要
英文摘要
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.
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会议论文
5-HT3 receptor antagonists for neuropathic pain
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批准号:10339438
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项目类别:
-
资助金额:$42.31万
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财政年份:2018
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负责人:Simon Haroutounian
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依托单位:
海外基金