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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04633655




Registration number
NCT04633655
Ethics application status
Date submitted
9/06/2020
Date registered
18/11/2020
Date last updated
25/05/2023

Titles & IDs
Public title
International CIPN Assessment and Validation Study
Scientific title
International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study
Secondary ID [1] 0 0
ICAVS
Universal Trial Number (UTN)
Trial acronym
ICAVS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-induced Peripheral Neuropathy 0 0
Quality of Life 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - outcome measures for CIPN testing

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


Other interventions: outcome measures for CIPN testing
questionnaires administration, physician based scales for CIPN data collection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in NCI-CTC v.5 sensory and motor grade
Timepoint [1] 0 0
5 YEARS
Primary outcome [2] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in PRO-CTCAE
Timepoint [2] 0 0
5 YEARS
Primary outcome [3] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in Pain Intensity Numerical Rating Scale (PI-NRS)
Timepoint [3] 0 0
5 YEARS
Primary outcome [4] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in NPS-CIN scale
Timepoint [4] 0 0
5 YEARS
Primary outcome [5] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN20© scale
Timepoint [5] 0 0
5 YEARS
Primary outcome [6] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in FACT-GOG NTX v.4© scale
Timepoint [6] 0 0
5 YEARS
Primary outcome [7] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSn© scale
Timepoint [7] 0 0
5 YEARS
Primary outcome [8] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in PGIC scale
Timepoint [8] 0 0
5 YEARS
Primary outcome [9] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in OXA-NQ scale
Timepoint [9] 0 0
5 YEARS
Secondary outcome [1] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in EORTC CIPN15 scale
Timepoint [1] 0 0
7 YEARS
Secondary outcome [2] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in TNSc© scale
Timepoint [2] 0 0
7 YEARS
Secondary outcome [3] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in nerve conduction studies
Timepoint [3] 0 0
7 YEARS
Secondary outcome [4] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in Quantitative sensory testing (QST)
Timepoint [4] 0 0
7 YEARS
Secondary outcome [5] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in neurofilament light chain (NfL) levels
Timepoint [5] 0 0
7 YEARS
Secondary outcome [6] 0 0
Chemotherapy-induced peripheral neurotoxicity as assessed by change in DN4 scale
Timepoint [6] 0 0
7 YEARS

Eligibility
Key inclusion criteria
Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:

1. Subjects must be candidates for neurotoxic chemotherapy at doses expected to be potentially neurotoxic (a list of neurotoxic drugs is provided in Appendix 1).
2. Male and female subjects who are 18 years of age or older.
3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.
4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.
5. Subjects must have a Karnofsky performance score greater than or equal to 70.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:

1. Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.
2. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
3. Severe depression that in the opinion of the Investigator would complicate the assessments.
4. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.
5. Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure).
6. Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g. metronidazole, isoniazid, amiodarone, antiretroviral medications).
7. Subjects with any other condition, which, in the investigator's judgment, might decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
8. Previous neurotoxic chemotherapy.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Brain and Mind Center - Sidney
Recruitment postcode(s) [1] 0 0
- Sidney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Vermont
Country [9] 0 0
Austria
State/province [9] 0 0
Vienna
Country [10] 0 0
Bangladesh
State/province [10] 0 0
Dhaka
Country [11] 0 0
Brazil
State/province [11] 0 0
Salvador
Country [12] 0 0
Canada
State/province [12] 0 0
Ottawa
Country [13] 0 0
Denmark
State/province [13] 0 0
Aarhus
Country [14] 0 0
France
State/province [14] 0 0
Clamart
Country [15] 0 0
France
State/province [15] 0 0
Limoges
Country [16] 0 0
Germany
State/province [16] 0 0
Cologne
Country [17] 0 0
Greece
State/province [17] 0 0
Larissa
Country [18] 0 0
Greece
State/province [18] 0 0
Patras
Country [19] 0 0
Italy
State/province [19] 0 0
Mb
Country [20] 0 0
Italy
State/province [20] 0 0
Como
Country [21] 0 0
Italy
State/province [21] 0 0
Genova
Country [22] 0 0
Italy
State/province [22] 0 0
Messina
Country [23] 0 0
Italy
State/province [23] 0 0
Padova
Country [24] 0 0
Italy
State/province [24] 0 0
Verona
Country [25] 0 0
Kenya
State/province [25] 0 0
Nairobi
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Busan
Country [27] 0 0
Portugal
State/province [27] 0 0
Vila Nova de Gaia
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Switzerland
State/province [29] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Other
Name
University of Milano Bicocca
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04633655
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GUIDO CAVALETTI, MD
Address 0 0
University of Milano Bicocca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
GUIDO CAVALETTI, MD
Address 0 0
Country 0 0
Phone 0 0
+ 39 02 6448 8039
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04633655