NCT04012632

Brief Summary

There was a worldwide early trend in girls'age for puberty onset. The timing of puberty onset varies greatly among individuals, and much of this variation is modulated by genetic factors. This study was designed to explored the association of polymorphisms in KISS1/GPR54 pathway genes and the risk of early puberty in Chinese Han girls.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
628

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

July 5, 2019

Last Update Submit

July 9, 2019

Conditions

Puberty, Precocious

Keywords

SNPkisspeptinGPR54

Outcome Measures

Primary Outcomes (1)

  • the polymorphism in the KISS1/GPR54 pathway genes

    functional SNP loci of the KISS1/GPR54 pathway genes KISS1, KISSIR, PLCB1, PRKCA, and ITPR1 were selected and detected.

    3 months

Study Arms (2)

cases

Early puberty cases of Han Chinese

controls

Controls were matched to cases at 1:1 by age (± 3 months)

Other: this study was an observational study and no interventions were given to the participants

Interventions

this study was an observational study and no interventions were given to the participantsOTHER

the participants were recruited and the data as well as blood sample were collected.

controls

Eligibility Criteria

Age7 Years - 10 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen

You may qualify if:

  • \- Clinical diagnosis of central precocious puberty or early and fast puberty.

You may not qualify if:

  • The participants who were not the first visit to the hospital and had been treated before.
  • The participants who were with endocrine disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li D, Wu Y, Cheng J, Liu L, Li X, Chen D, Huang S, Wen Y, Ke Y, Yao Y, Su Z, Zhou L. Association of Polymorphisms in the Kisspeptin/GPR54 Pathway Genes With Risk of Early Puberty in Chinese Girls. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz229. doi: 10.1210/clinem/dgz229.

    PMID: 32160304DERIVED

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 9, 2019

Study Start

September 1, 2016

Primary Completion

May 20, 2018

Study Completion

July 4, 2019

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share