UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective cohort study of effect on sexuality after treatment among cervical cancer patients (JGOG9004)
Title of the study (Brief title)	Sexuality change among cervical cancer patients (JGOG9004)
Region	Japan

Condition
Condition	cervical cancer
Classification by specialty	Hematology and clinical oncology Obsterics 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	Hitomi Sakai
Organization	Kindai University Faculty of Medicine
Division name	Department of Medical Oncology
Address	377-2, Ohnohigashi, Osakasayama, Osaka, 589-8511, Japan
TEL	0723660221
Email	sakai_h@med.kindai.ac.jp

Public contact
Name of contact person	Hitomi Sakai
Organization	Kindai University Faculty of Medicine
Division name	Department of Medical Oncology
Address	377-2, Ohnohigashi, Osakasayama, Osaka, 589-8511, Japan
TEL	0723660221
Homepage URL	http://www.jgog.gr.jp/
Email	sakai_h@med.kindai.ac.jp

Sponsor
Institute	Japanese Gynecologic Oncology Group
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 07 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038358