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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044400
Receipt No. 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 2021/06/02

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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
Email 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
Email m0adachi@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

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
Email 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 Preinitiation
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
2021 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050542

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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