UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044400 |
|---|---|
| Receipt number | R000050542 |
| Scientific Title | Registry of female precocious puberty, aiming identification of predisposing factors, optimization of treatment strategy, and elucidation of prognosis |
| Date of disclosure of the study information | 2021/06/03 |
| Last modified on | 2022/06/04 16:16:29 |
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Basic information
Public title
Registry of female precocious puberty, aiming identification of predisposing factors, optimization of treatment strategy, and elucidation of prognosis
Acronym
Precocious puberty registry
Scientific Title
Registry of female precocious puberty, aiming identification of predisposing factors, optimization of treatment strategy, and elucidation of prognosis
Scientific Title:Acronym
Precocious puberty registry
Region
| Japan |
Condition
Condition
female central precocious puberty
Classification by specialty
| Endocrinology and Metabolism | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective patient registry, for girls with central precocious puberty, will be constructed.
Basic objectives2
Others
Basic objectives -Others
This study will register prospectively the consecutive female patients with central precocious puberty evaluated at Showa University Hospital. Data obtained from a large number of patients will contribute to reveal the predisposing factors. Analysis of long-term treatment will be useful to develop clinical guideline in future.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Information collected at the time of diagnosis: family history, maternal information during pregnancy, perinatal history, past history, social history, growth data, physical findings, endocrine test (LH, FSH, E2, DHEA-S, TSH, Free T3, Free T4, IGF-1), Bone age, ultrasonic findings of uterus and ovary, MRI findings in hypothalamo-pituitary region
2) Information collected during follow-up or treatment
For non-treatment patients: growth data, physical findings, bone age (every 6 months to 1 year until menarche)
For patients with LHRH analog treatment: growth data, physical findings, endocrine test, bone age, ultrasonic findings, treatment details
3) Information to be collected after the completion of treatment
growth data, physical findings, endocrine tests, ultrasonography (6-months and one year following the cessation)
Key secondary outcomes
Serum will be cryopreserved for each patient.
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
| 1 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Female
Key inclusion criteria
Female patients who will be diagnosed with central precocious puberty (gonadotropin-dependent precocious puberty) at Department of Pediatrics, Showa University Hospital after July 2021.
Key exclusion criteria
1) premature thelarche
2) central precocious puberty with organic origin
3) gonadotropin-independent precocious puberty
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Adachi |
Organization
Showa University School of Medicine
Division name
Department of Pediatrics
Zip code
142-8666
Address
Hatanodai 1-5-8, Shinagawa-ku, Tokyo
TEL
03-3784-8565
m0adachi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Adachi |
Organization
Showa University School of Medicine
Division name
Department of Pediatrics
Zip code
142-8666
Address
Hatanodai 1-5-8, Shinagawa-ku, Tokyo
TEL
03-3784-8565
Homepage URL
m0adachi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SURAC, Showa University
Address
Hatanodai 1-5-8, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.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 | 06 | Month | 03 | 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
| 2021 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observation period is as follows.
1) In the case of untreated follow-up, observation will be continued until menarche.
2) For cases treated with LHRH analog, observation will be continued 12 months after the end of treatment or until (re)start of menstruation.
Management information
Registered date
| 2021 | Year | 06 | Month | 02 | Day |
Last modified on
| 2022 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050542
