UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045292 |
|---|---|
| Receipt number | R000051731 |
| 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 |
| Date of disclosure of the study information | 2021/09/29 |
| Last modified on | 2021/09/29 17:12:08 |
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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 |
| Obstetrics 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
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
yastakai@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051731
