UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033641 |
|---|---|
| Receipt number | R000038358 |
| Scientific Title | A prospective cohort study of effect on sexuality after treatment among cervical cancer patients (JGOG9004) |
| Date of disclosure of the study information | 2018/08/06 |
| Last modified on | 2019/01/09 14:43:03 |
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Basic information
Public title
A prospective cohort study of effect on sexuality after treatment among cervical cancer patients (JGOG9004)
Acronym
Sexuality change among cervical cancer patients (JGOG9004)
Scientific Title
A prospective cohort study of effect on sexuality after treatment among cervical cancer patients (JGOG9004)
Scientific Title:Acronym
Sexuality change among cervical cancer patients (JGOG9004)
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Hematology and clinical oncology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal sexuality change after cancer treatment among Japanese cervical cancer patients using Female Sexual Function Index (FSFI) and Hospital Anxiety and Depression Scale (HADS).
Basic objectives2
Others
Basic objectives -Others
To clarify the factors related to sexual dysfunction after cancer treatment in Japanese primary cervical cancer patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
FSFI
-change from baseline to 12 months after treatment start
Key secondary outcomes
sexual activity
HADS
-change from baseline to 12 months after treatment start
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Patient who has pathologically diagnosed cervical cancer.
2) Patient who was diagnosed of cervical cancer within 3 months before registration.
3) FIGO IA - IIIB(FIGO 2008).
4) ECOG PS 0 - 1.
5) Aged 20 years and over and under 70
6) A patient who is a married woman.
7) A patient planning curative surgery or radical radiation therapy (including chemoradiotherapy) within 2 months after enrollment.
8) A patient whose consent was obtained in writing.
Key exclusion criteria
1) Patients who have judged that research researcher or research sharing doctor is inappropriate for participation in this study.
2) Patients planning preoperative chemotherapy.
3) Pregnant patient.
4) Patients with mental disease.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitomi Sakai |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2, Ohnohigashi, Osakasayama, Osaka, 589-8511, Japan
TEL
0723660221
sakai_h@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitomi Sakai |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2, Ohnohigashi, Osakasayama, Osaka, 589-8511, Japan
TEL
0723660221
Homepage URL
http://www.jgog.gr.jp/
sakai_h@med.kindai.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Gynecologic Oncology Group
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
Address
Tel
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
婦人科悪性腫瘍研究機構
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2018 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038358
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
