UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013875 |
|---|---|
| Receipt number | R000016122 |
| Scientific Title | Multi-institutional Survey of Patients with Cancer Pain for Gynecologic Cancer |
| Date of disclosure of the study information | 2014/05/02 |
| Last modified on | 2020/11/05 11:18:27 |
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Basic information
Public title
Multi-institutional Survey of Patients with Cancer Pain for Gynecologic Cancer
Acronym
Survey for Gynecologic Cancer Pain
Scientific Title
Multi-institutional Survey of Patients with Cancer Pain for Gynecologic Cancer
Scientific Title:Acronym
Survey for Gynecologic Cancer Pain
Region
| Japan |
Condition
Condition
Gynecologic Malignancies
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the present status of cancer pain (nociceptive pain/neoropathic pain/mixed pain)in gynecologic cancer patients
Basic objectives2
Others
Basic objectives -Others
reserch survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Patient demographics
2.Pain related
3.QOL related
4.Data of Cancer lesion causing the pain
5.Imaging
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
Female
Key inclusion criteria
1. Patients over 20 ages at study entry
2. Patients with clinical diagnosis of gynecological cancer
3. Patients with pain caused by gynecologic cancer or treatment for cancer
4. Patients not administered opioids at study entry
5. Patients able to communicate and assess his/her own symptoms
6. Patients assessed ECOG-PS as 0-3
7. Patients agreed with the written informed consent
Key exclusion criteria
none
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | SHINYA |
| Middle name | |
| Last name | SATO |
Organization
Tottori University School of medicine
Division name
Obstetrics and Gynecology
Zip code
683-8504
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6647
sshinya@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | SHINYA |
| Middle name | |
| Last name | SATO |
Organization
Tottori University School of medicine
Division name
Obstetrics and Gynecology
Zip code
683-8504
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6647
Homepage URL
sshinya@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University School of medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Palliative Medicine (JSGPM)
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
Institutional Review Board, Faculty of Medicine, Tottori University
Address
36-1 Nishi-cho, Yonago, Tottori
Tel
0859-33-1111
toridai-chiken@ml.med.tottori-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
| 2014 | Year | 05 | Month | 02 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Multi-institutional research survey of cancer related pain in patients with gynecologic cancer
Management information
Registered date
| 2014 | Year | 05 | Month | 02 | Day |
Last modified on
| 2020 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016122
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
