UMIN-CTR Clinical Trial

Basic information
Public title	Outcomes of oncofertility care in adolescent and young adult cancer patients with Japan Oncofertility Registry
Acronym	Outcomes with JOFR
Scientific Title	Outcomes of oncofertility care in adolescent and young adult cancer patients with Japan Oncofertility Registry
Scientific Title:Acronym	Outcomes with JOFR
Region	Japan

Condition
Condition	Cancer
Classification by specialty	Endocrinology and Metabolism Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Pediatrics Ophthalmology Dermatology Oto-rhino-laryngology Orthopedics Urology Radiology Oral surgery Neurosurgery Nursing Adult Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To monitor and clarify the outcomes (prognosis and pregnancy rate, etc) of oncofertility care in adolescent and young adult cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cancer prognosis, pregnancy rate
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with malignancy, autoimmune diseases, ovarian tumors etc., whose treatment may deteriorate their reproductive function, and 1) who had counseling or treatments for fertility preservation, such as cryopreservation of oocytes, embryos, ovarian tissue, sperm, or testicular tissue, 2) who expressed a written informed consent
Key exclusion criteria	Patients who lacked a sense of judgement
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Takai
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Obstetrics and Gynecology
Zip code	3508550
Address	1981 Kamoda, Kawagoe
TEL	0492283681
Email	yastakai@saitama-med.ac.jp

Public contact
Name of contact person	1st name Yasushi Middle name Last name Takai
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Obstetrics and Gynecology
Zip code	3508550
Address	1981 Kamoda, Kawagoe
TEL	0492283681
Homepage URL	http://www.j-sfp.org/about/jofr.html
Email	yastakai@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Administration Center of Saitama Medical Center
Address	1981 Kamoda, Kawagoe
Tel	049-228-3400
Email	irbsmc@saitama-med.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	2020 Year 06 Month 13 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	Open public recruiting
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2018 Year 11 Month 01 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Analysis of JOFR data

Management information
Registered date	2020 Year 06 Month 12 Day
Last modified on	2020 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046519