International CIPN Assessment and Validation Study (ICAVS)

Active:	Yes
Cancer Type:		NCT ID:	NCT04633655
Trial Phases:		Protocol IDs:
Eligibility:	, Male and Female	Study Type:
Study Sponsor:	University of Milano Bicocca
NCI Full Details:

Summary

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

Objectives

Aims: The primary aim for this study is to test responsiveness of the different assessment methods used in the core study, in a multi-center, multi-regional International setting, comparing changes from baseline to end of treatment. Secondary aims are:

to evaluate responsiveness (changes from base line to end of treatment) also of the other outcome measures used in the Extended Study;
to evaluate mid-treatment data predictiveness of end of treatment neurological status for each outcome measure;
to evaluate recovery rate/modification of the neurological status for the follow up evaluations (3/6/12/24 months after treatment), stratifying data for different drugs.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

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