UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054887 |
|---|---|
| Receipt number | R000062714 |
| Scientific Title | Exploratory study of genetic polymorphisms associated with onset and severity of chemotherapy-induced peripheral neuropathy by nanoparticle albumin-bound paclitaxel |
| Date of disclosure of the study information | 2024/07/05 |
| Last modified on | 2024/07/05 14:14:06 |
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Basic information
Public title
Exploratory study of genetic polymorphisms associated with onset and severity of chemotherapy-induced peripheral neuropathy by nanoparticle albumin-bound paclitaxel
Acronym
Exploratory study of genetic polymorphisms associated with onset and severity of chemotherapy-induced peripheral neuropathy by nanoparticle albumin-bound paclitaxel
Scientific Title
Exploratory study of genetic polymorphisms associated with onset and severity of chemotherapy-induced peripheral neuropathy by nanoparticle albumin-bound paclitaxel
Scientific Title:Acronym
Exploratory study of genetic polymorphisms associated with onset and severity of chemotherapy-induced peripheral neuropathy by nanoparticle albumin-bound paclitaxel
Region
| Japan |
Condition
Condition
Pancreatic cancer, gastric cancer, non-small cell lung cancer, or breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate association between chemotherapy-induced peripheral neuropathy by nanoparticle albumin-bound paclitaxel and genetic polymorphisms
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between interpatient variability of time to onset of chemotherapy-induced peripheral neuropathy from starting nanoparticle albumin-bound paclitaxel and genetic polymorphisms
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient who are diagnosed as pancreatic cancer, gastric cancer, non-small cell lung cancer, or breast cancer, and planed chemotherapy with nanoparticle albumin-bound paclitaxel (nabPTX)
2) More than fourteen days are passed from last chemotherapy administration in patient who were previously treated
3) Patient who is older than 20 years old at the starting nabPTX
4) Patient with Eastern Cooperative Oncology Group Performance status 0 to 2
5) Patient whose life expectancy is more than 3 months
6) Patient who do not have severe organ disorder and applicable to following criteria;
Neutrophil count is more than 1,500/mm3,
Platelet count is more than 75,000/mm3,
Hemoglobin concentration is more than 9.0g/dL,
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are twice of upper limit of normal or less; if patient involves liver metastasis, AST and ALT are allowed
until 5 times of upper limit of normal or less,
Serum creatinine value is 1.5mg/dL or less
7) Patient who provided written informed consent to participate in the study
Key exclusion criteria
1) Patient with interstitial pneumonia or lung fibrosis
2) Patient with serious infection
3) Patient with sensory neuropathy; however, patient who was previously received chemotherapy is allowed to participate in the study if chemotherapy-induced peripheral neuropathy has been recovered grade 1 on Common Terminology Criteria for Adverse Event or less
4) Patient who previously received paclitaxel or nabPTX
5) Patient who suffered from unstable angina or acute myocardial infarction within 3 months
6) Patient with serious disease, i.e. uncontrollable diabetes, liver cirrhosis, etc
7) Patient with active synchronous cancer
8) Patient with active viral hepatitis; however, patient is allowed to participate regardless serological positive for hepatitis B antigen in the study if HBV-DNA level is less than measuring sensitivity
9) Patient who is unsuitable to participate in the study due to mental or neurological disorder
10) Woman with pregnant, lactating women or who wish to pregnant, or man who wish to have children
11) Patient with serious allergy to medicine
12) Patient with unsuitable condition to participate in the study due to any reason by physician's judgement
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Ishida |
Organization
Showa University
Division name
Division of Medical Oncology, Department of Internal Medicine, Showa University Northern Yokohama Hosipital
Zip code
224-8503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
045-949-7000
hishida@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Ishida |
Organization
Showa University
Division name
Division of Medical Oncology, Showa University Northern Yokohama Hospital
Zip code
224-8503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
045-949-7000
Homepage URL
hishida@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2024 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062714
