Puberty, PrecociousNCT04012632
Kisspeptin/GPR54 Pathway and Early Puberty
An observational study of Puberty, Precocious, run by Shenzhen Center for Disease Control and Prevention.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Puberty, Precocious
- How many people
- 628 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 4 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen
Who may be able to join
- Clinical diagnosis of central precocious puberty or early and fast puberty.
Who cannot join
- The participants who were not the first visit to the hospital and had been treated before.
- The participants who were with endocrine disorders.
About this study
Official title: Polymorphisms in the Kisspeptin/GPR54 Pathway Genes and the Risk of Early Puberty
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.
- Conditions
- Puberty, Precocious
- Being tested
- this study was an observational study and no interventions were given to the participants
- Keywords
- SNP, kisspeptin, GPR54
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| cases | Early puberty cases of Han Chinese | |
| controls | Controls were matched to cases at 1:1 by age (± 3 months) Receives: Other: this study was an observational study and no interventions were given to the participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Sep 2016
- Primary completion20 May 2018
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Puberty, PrecociousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Di Li, Shenzhen Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012632
- Sponsor's protocol ID
- szCDC_1
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32160304
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms in the Kisspeptin/GPR54 Pathway Genes and the Risk of Early Puberty
- ClinicalTrials.gov ID
- NCT04012632
- Acronym / sponsor ID
- szCDC_1
- Conditions
- Puberty, Precocious
- Keywords
- SNP, kisspeptin, GPR54
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Shenzhen Center for Disease Control and PreventionOther government
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | –Early puberty cases of Han Chinese |
| controls | – | Other: this study was an observational study and no interventions were given to the participantsControls were matched to cases at 1:1 by age (± 3 months) |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen
Key inclusion criteria (1 listed)
- Clinical diagnosis of central precocious puberty or early and fast puberty.
Key exclusion criteria (2 listed)
- The participants who were not the first visit to the hospital and had been treated before.
- The participants who were with endocrine disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this study was an observational study and no interventions were given to the participantsthe participants were recruited and the data as well as blood sample were collected. | Other | controls |
Primary outcome
the polymorphism in the KISS1/GPR54 pathway genes
Time frame: 3 months
functional SNP loci of the KISS1/GPR54 pathway genes KISS1, KISSIR, PLCB1, PRKCA, and ITPR1 were selected and detected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Derived from this study: PubMed 32160304Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Puberty, Precocious, run by Shenzhen Center for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the polymorphism in the KISS1/GPR54 pathway genes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04012632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.