UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000016122