RECRUITING

International CIPN Assessment and Validation Study

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Conditions

Chemotherapy-induced Peripheral NeuropathyQuality of LifeclinimetricsbiomarkerPROoutcome measures

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study

Quick Facts

Study Start:2020-06-08
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04633655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

GUIDO CAVALETTI, MD
CONTACT
+ 39 02 6448 8039
guido.cavaletti@unimib.it
PAOLA ALBERTI, MD, PhD
CONTACT
+39 02 6448 8154
paola.alberti@unimib.it

Principal Investigator

GUIDO CAVALETTI, MD
STUDY_CHAIR
University of Milano Bicocca
PAOLA ALBERTI, MD
PRINCIPAL_INVESTIGATOR
University of Milano Bicocca

Study Locations (Sites)

Birmingham School of Nursing, University of Alabama
Birmingham, Alabama, 35294
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
JHU
Baltimore, Maryland, 21224
United States
University of Michigan School of Nursing
Ann Arbor, Michigan, 48109
United States
Columbia University Irving Medical Center
New York, New York, 10027
United States
Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division
Columbus, Ohio, 43220
United States
Dartmouth-Hitchcock Medical Center
Lebanon, Pennsylvania, 03756
United States
University of Vermont Medical Center
Burlington, Vermont, 05445
United States

Collaborators and Investigators

Sponsor: University of Milano Bicocca

  • GUIDO CAVALETTI, MD, STUDY_CHAIR, University of Milano Bicocca
  • PAOLA ALBERTI, MD, PRINCIPAL_INVESTIGATOR, University of Milano Bicocca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-08
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2020-06-08
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

  • clinimetrics
  • biomarker
  • PRO
  • outcome measures

Additional Relevant MeSH Terms

  • Chemotherapy-induced Peripheral Neuropathy
  • Quality of Life