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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013875
Receipt No. 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

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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
Obsterics 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
Email 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
Email sshinya@med.tottori-u.ac.jp

Sponsor
Institute Tottori University School of medicine
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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