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First Morning Voided Urinary Gonadotropin Measurements for the Early Screening, Diagnosis and Follow-up of CPP Patients

First Morning Voided Urinary Gonadotropin Measurements for the Early Screening, Diagnosis and Follow-up of CPP Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034464
Enrollment
Unknown
Registered
2020-07-05
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central precocious puberty

Interventions

Gold Standard:Clinical outcome by CPP diagnostic standards
Index test:morning urine GN

Sponsors

Department of Pediatrics, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: PP groups inclusion criterion is the appearance of secondary sexual characteristics before the age of 8 for girls and 9 for boys. The informed consent must be granted by all the participants and their guardian(s) Healthy pediatric population will also be enrolled to this Study, where its inclusion criterion will be healthy aged 6 to 12 patients without CPP, hepatopathy, nephropathy, congenital heart disease, and hereditary metabolic diseases. The informed consent must also be granted by these healthy participants and their guardian(s). Diagnosis of CPP The diagnosis for CPP used in this study will follow the following parameters: 1) The appearance of secondary sexual characteristics before the age of 8 for girls and 9 for boys, characterized by breast nodules in girls and increased testicular volume in boys; 2) Accelerated growth, much quicker than normal children; 3) Advanced bone age, one year or more prior to their actual age; 4) Enlarged gonads: Ultrasound examination of pelvis showing increase in uterine and ovarian volumes and multiple follicles with the diameter >4mm for girls, or testicular volume >=4ml for boys; 5) Activation of HPGA function; serum gonadotropin and sex hormones reaching the levels of puberty. (Meeting the criterion set in the 2015 year version of The Consensus on the Diagnosis and Treatment of Central Precocious Puberty )

Exclusion criteria

Exclusion criteria: Patients with peripheral PP due to tumors, exogenous factors, CAH, and Mccune-Albright syndrome, hepatopathy, nephropathy, congenital heart disease, and hereditary metabolic diseases will be excluded.

Design outcomes

Primary

MeasureTime frame
Urine Gn;Cut-off point (threshold);SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactXiaoping Luo

Department of Pediatrics, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

xpluo@tjh.tjmu.edu.cn+86 13387522645

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026