International CIPN Assessment and Validation Study (ICAVS)
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ClinicalTrials.gov Identifier: NCT04633655 |
Recruitment Status :
Recruiting
First Posted : November 18, 2020
Last Update Posted : May 25, 2023
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Tracking Information | |||||||||
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First Submitted Date | June 9, 2020 | ||||||||
First Posted Date | November 18, 2020 | ||||||||
Last Update Posted Date | May 25, 2023 | ||||||||
Actual Study Start Date | June 8, 2020 | ||||||||
Estimated Primary Completion Date | May 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | International CIPN Assessment and Validation Study | ||||||||
Official Title | International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study | ||||||||
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. | ||||||||
Detailed Description | The study will be performed at all participating centers and will consist of the following assessments: Core study (assessments at baseline and at the end of treatment)
Extended study (at all available sites - any combination of assessment methods is allowed, minimum at baseline and at the end of treatment)
Rationale: Within a multi-center international collaboration among experienced neurologists, oncologists, nurses and symptom scientists, the principal aim of this study is to evaluate responsiveness of a set of outcome measures for CIPN evaluation in order to define the gold standard for its assessment. The assessment of CIPN will be performed at different levels of investigation. The Core study will allow the evaluation of subjects with common devices, so that an assessment can be performed at any medical site (expected time for questionnaires completion 15 minutes). The Extended study will add any combination of the listed assessment methods/biological sample collection, in order to ascertain whether this approach can provide a more careful and clinically-relevant estimate of the peripheral nervous system damage. Comparison between healthcare evaluation and subjects' report of CIPN severity using established questionnaires will be performed in both Core and Extended studies. 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:
Study Design: 1000 patients who are candidates for neurotoxic chemotherapy for any cancer with non-investigational drugs (including immune checkpoint inhibitors and "targeted" drugs) will be enrolled from participating centers. A trained investigator in each participating center will perform the selected healthcare-assessed scales and supervise the patient-completed measures as presented in Table 1. Subjects will be examined at least at baseline and end of treatment (Core Study) and at additional intermediate and follow-up timepoints (Extended study), according to their treatment plan. Study Treatments: There are no study-specified treatments, as subjects will receive only their standard of care chemotherapy. The investigators will not influence decisions regarding treatment duration nor supply medication for this study. However, all treatment regimens will be registered. Participating Centers minimum requirements: Participating Centers should:
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples Without DNA Description: Serum samples for neurofilament light chain detection
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Sampling Method | Non-Probability Sample | ||||||||
Study Population | Consecutive patients candidated to neurotoxic chemotherapy | ||||||||
Condition |
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Intervention | Other: outcome measures for CIPN testing
questionnaires administration, physician based scales for CIPN data collection
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Study Groups/Cohorts | Patients who are receiving a neurotoxic chemotherapy
List of neurotoxic drugs eligible for enrolment
Intervention: Other: outcome measures for CIPN testing
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
1000 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | October 1, 2025 | ||||||||
Estimated Primary Completion Date | May 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
Subjects presenting with any of the following will not be included in the study:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Australia, Austria, Bangladesh, Brazil, Canada, Denmark, France, Germany, Greece, Italy, Kenya, Korea, Republic of, Portugal, Spain, Switzerland, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04633655 | ||||||||
Other Study ID Numbers | ICAVS | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | University of Milano Bicocca | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | University of Milano Bicocca | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | University of Milano Bicocca | ||||||||
Verification Date | May 2023 |