UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054421 |
|---|---|
| Receipt number | R000062160 |
| Scientific Title | Cross-sectional study on neuropathic pain in cancer patients |
| Date of disclosure of the study information | 2024/05/20 |
| Last modified on | 2025/08/07 17:55:29 |
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Basic information
Public title
Cross-sectional study on neuropathic pain in cancer patients
Acronym
Cross-sectional study on neuropathic pain in cancer patients
Scientific Title
Cross-sectional study on neuropathic pain in cancer patients
Scientific Title:Acronym
Cross-sectional study on neuropathic pain in cancer patients
Region
| Japan |
Condition
Condition
Neuropathic pain in cancer patients
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the proportion of cancer patients with possible neuropathic pain. Furthermore, the actual treatment status and satisfaction with treatment of pain and quality of life will be examined.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with possible neuropathic pain.
Key secondary outcomes
Location of pain, NRS of pain, where to consult for pain, communication with health care providers, impact on life, percentage of patients with possible neuropathic pain by cancer type
Percentage of patients with possible neuropathic pain by stage
Breakdown of analgesics used and satisfaction with each of them
EQ-5D-5L (quality of life score)
Percentage of patients scoring 9 or higher on S-LANSS (overall, cancer type, stage)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been notified of their cancer and whose stage is II or higher
2) Patients who are 18 years of age or older at the time consent is obtained.
3) Patients who are able to understand the procedures of this study, are able to respond appropriately to questions in Japanese without assistance, and are able to give their free and voluntary consent to participate in the study.
Key exclusion criteria
No setting in this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshi |
| Middle name | |
| Last name | Yasuda |
Organization
DAIICHI SANKYO CO., LTD.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo
TEL
03-6225-1111
yasuda.yoshi.gn@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Haruhiko |
| Middle name | |
| Last name | Seki |
Organization
INTAGE Healthcare Inc.
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai Chiyoda-ku, Tokyo
TEL
03-5295-1579
Homepage URL
haruhiko.seki@intage.com
Sponsor or person
Institute
DAIICHI SANKYO CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3, Kichijoji-kitamachi, Musashino-shi, Tokyo,180-0001, Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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 | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1093/jjco/hyaf116
Number of participants that the trial has enrolled
930
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary Endpoint
Calculate the proportion of patients with possible neuropathic pain and its 95% confidence interval.
Other endpoints
Calculate the proportion of patients with possible neuropathic pain by cancer type and stage, and its 95% confidence interval. In addition, calculate the number and proportion of patients who responded to each item to be selected
Management information
Registered date
| 2024 | Year | 05 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062160
