ESPE2023 Poster Category 1 Pituitary, Neuroendocrinology and Puberty (73 abstracts)
First interim analysis of the value of First Morning Voided（FMV）Urinary GnRH for the Diagnosis in China CPP Patients
Feng Ye 1 , Xiaoping Luo 1 , Guoqing Dong 2 , Ruimin Chen 3 , Zhiya Dong 4 , Wenli Lu 4 , Feihong Luo 5 , Chunxiu Gong 6 , Liya Wei 6 , Yu Yang 7 , Min Zhu 8 , Huamei Ma 9 , Qiuli Chen 9 , Xinran Cheng 10 & Peng Gou 10
1Tongji Hospital. Tongji Medical College. Huazhong University of Science&Technology, Wuhan, China. 2Shenzhen Maternity & Child Healthcare Hospital, Shenzhen, China. 3Fuzhou Children's Hospital of Fujian Province, Fuzhou, China. 4Ruijin Hospital. Shanghai Jiao Tong University Medical School, Shanghai, China. 5Children's Hospital of Fudan University, Shanghai, China. 6Beijing Children's Hospital, Capital Medical University, Beijing, China. 7Jiangxi Province Children's Hospital, Nanchang, China. 8Children's Hospital of Chongqing Medical University, Chongqing, China. 9First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. 10The affiliated Women's and Children's Hospital, School of Medicine. University of Electronic Science and Technology of China, Chengdu, China
Background: The gold standard for CPP diagnosis is gonadotropin releasing hormone stimulation test (GnRHST). However, this test is expensive, invasive and inconvenient for screening. Some recent studies have demonstrated that the FMV urinary luteinizing hormone (U-LH) has a strong correlation with LH peak value and serum basal LH, and a high consistency with Tanner staging results, but due to the lack of large-sample, multicenter clinical research data, a formal standard of FMV urinary Gn has not been established for CPP screening, diagnosis and treatment assessment yet.
Objective: To explore a reasonable cut-off value of FMV urinary Gn for CPP early screening, diagnosis and treatment assessment in China.
Patients and Methods: This is a multicenter, prospective and non-interventional study is being conducted across 10 sites in China to evaluate the value of FMV urinary Gn in screening, diagnosis and follow-up of CPP patients. This study comprises two cohorts: 6,000 healthy children (aged 6-12 years) are enrolled and classified at different Tanner stages to explore the ideal cut-off value of FMV U-LH, and U-LH/U-FSH as a screening indicator for clinically established puberty; 400 precocious puberty patients will also be enrolled to determine if FMV U-Gn correlates with GnRHST results, and the sensitivity and specificity of U-Gn for diagnosis of CPP at different cut-off values will be evaluated to determine the cut-off value. The CPP group will be followed up every three months for a year to evaluate the value of FMV U-Gn in follow-up assessment of CPP patients.
Results: Overall, 142 children diagnosed with CPP were included in this interim analysis; 92.3% female. FMV urinary LH(U-LH), basal serum LH were significantly positively correlated with GnRH-stimulated serum LH(r= 0.2, P<0.01; r= 0.39, P<0.001, respectively). The diagnostic ability of FMV urinary gonadotropins was assessed by receiver operating characteristic (ROC) curve analysis. The optimal cutoff values for positive GnRHST result prediction were determined to be 1.68 IU/L for FMV urinary LH (sensitivity, 57.9%; specificity, 84.4%; and AUC 0.700 (0.639-0.757); p < 0.0001), and 0.16 for the FMV urinary LH:FSH ratio (sensitivity, 69.2%; specificity, 87%; and AUC 0.843 (0.791–0.886); P< 0.0001).
Conclusion: The FMV urinary LH levels were significantly positively correlated with the pubertal response to the GnRHST. U-LH could be a potential biomarker for CPP auxiliary diagnosis and early screening.
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