UMIN-CTR Clinical Trial

Basic information
Public title	Outcomes of oncofertility care in adolescent and young adult cancer patients with Japan Oncofertility Registry which is linked with patient-reported outcomes and national cancer registry
Acronym	Outcomes with revised JOFR
Scientific Title	Outcomes of oncofertility care in adolescent and young adult cancer patients with Japan Oncofertility Registry which is linked with patient-reported outcomes and national cancer registry
Scientific Title:Acronym	Outcomes with revised JOFR
Region	Japan

Condition
Condition	cancer, autoimmune diseases
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Cardiology Pneumology Endocrinology and Metabolism Hematology and clinical oncology Nephrology Neurology Clinical immunology Infectious disease Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Pediatrics Ophthalmology Dermatology Psychiatry Oto-rhino-laryngology Orthopedics Urology Radiology Anesthesiology Oral surgery Neurosurgery Cardiovascular surgery Plastic surgery Aesthetic surgery Operative medicine Rehabilitation medicine 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 childhood, adolescent and young adult patients with cancer and autoimmune diseases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	treatment 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
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	IRB of Tohoku University Hospital
Address	2-1 Seiryocho, Aoba-ku, Sendai
Tel	022-728-4105
Email	ec@rinri.hosp.tohoku.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	2021 Year 09 Month 29 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	Preinitiation
Date of protocol fixation	2021 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date	2021 Year 11 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	none

Management information
Registered date	2021 Year 08 Month 28 Day
Last modified on	2021 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051731