International CIPN Assessment and Validation Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Milano Bicocca
Study ID
NCT04633655
Status
Recruiting
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Conditions

  • Chemotherapy-induced Peripheral Neuropathy
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • outcome measures for CIPN testing — OTHER
    questionnaires administration, physician based scales for CIPN data collection

Study Details

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.

Key Dates

Start date
Jun 8, 2020
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Patients who are receiving a neurotoxic chemotherapy
    List of neurotoxic drugs eligible for enrolment * Platinum drugs * Taxanes * Vinca alkaloids * Epothilones * Proteasome inhibitors * Thalidomide * Vedotin-based drugs * checkpoint inhibitors * Any combination of the aforementioned drugs

Primary Outcome Measure

Chemotherapy-induced peripheral neurotoxicity as assessed by change in NCI-CTC v.5 sensory and motor grade [ Time Frame: 5 YEARS ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Birmingham School of Nursing, University of AlabamaBirminghamAlabama35294
Ellen M. Lavoie Smith, PhD
[email protected]
Northside HospitalAtlantaGeorgia30342
Guilherme Cantuaria, MD, PhD
[email protected]
Margaret Ferreira
JHUBaltimoreMaryland21224
Khoshnoodi Mohammad, MD
[email protected]
410-502-7683
University of Michigan School of NursingAnn ArborMichigan48109
Ellen Lavoie Smith, PhD
[email protected]
734-936-1267
Columbia University Irving Medical CenterNew YorkNew York10027
Thomas III H Brannagan, MD
[email protected]
212-305-0405
Cancer Center/Wexner Medical Center - Ohio State Medical Oncology DivisionColumbusOhio43220
Maryam Lustberg, MD, MPH
[email protected]
410-299-1044
Dartmouth-Hitchcock Medical CenterLebanonPennsylvania03756
Victoria H Lawson, MD
[email protected]
603-650-5104
University of Vermont Medical CenterBurlingtonVermont05445
Noah Kolb, MD
[email protected]
978-886-2828

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By research site
Birmingham School of Nursing, University of Alabama· Birmingham, ALNorthside Hospital· Atlanta, GAJHU· Baltimore, MDUniversity of Michigan School of Nursing· Ann Arbor, MIColumbia University Irving Medical Center· New York, NYCancer Center/Wexner Medical Center - Ohio State Medical Oncology Division· Columbus, OH

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