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临床试验/CTRI/2021/06/034124
CTRI/2021/06/034124尚未招募不适用

Isosexual Precocious Puberty: Single- center experience

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
NOT APPLICABLE

研究概览

简要总结

INTRODUCTION:

Precociouspuberty (PP) is defined as the onset of secondary sexual characteristics before8 years in girls and 9 years in boys.(1)Observational data from the US show that at age 7, 10%ofwhite girls and 23% of black girls have started puberty.(2)

Precocious puberty is classified as gonadotrophindependent or central precocious puberty (CPP), and gonadotrophin independent orperipheral precocious puberty (PPP).Approximately 90% ofgirls and 25%-60% of boys with CPP have an idiopathic cause (3)(4). Rareassociation with genetic mutations in KISS1, KISS1R, MKRN3 and DLK1 have alsobeen described. Clinicallypatients present with early pubertal changes. LHconcentrations < 0.3 mIU/L are in the prepubertal range, and  >0.3 mIU/L are usually indicative ofpuberty (4)

 GnRHstimulation test should be done in clinically equivocal cases.In the GnRHstimulation test, pubertal individuals have a stimulated peak LH of at least~4-6 mIU/L, whereas prepubertal children will have a minimal increase frombaseline.(5)

   Otherthan arresting puberty, for physical and psychological reasons, preserving adultheight is an important long term goal(4)

Themost common treatment used for CPP is intramuscularleuprolide depot.

Forgonadotrophin-independent precocious puberty, treatment options includearomatase inhibitors, SERM, and androgen synthesis inhibitors likeketoconazole.

Surgeryis the treatment of choice for gonadal tumors.

 There are only a few studies reported from Indiadescribing this condition. Hence, we aim to retrospectively study patients’clinical, biochemical, and treatment profiles with precocious puberty from asingle center in Western India.

AIMS AND OBJECTIVES

·       Tostudy the clinical, biochemical, imaging, management, and outcome of patients withprecocious puberty.

TYPE OF STUDY:Retrospective study

SAMPLESIZE: All patients who had presented to endocrine OPDwillbe included in the study (approximately 100 patients).

INCLUSION CRITERIA:

·       Isosexualprecocious puberty

EXCLUSION CRITERIA:

·       Patientswith heterosexual forms of precocious puberty (e.g congenital adrenalhyperplasia).

·       Patientswith premature thelarche, premature puberache.

STUDY SETTINGS:

Thedata of patients with precocious puberty will be retrieved from medical recordsfrom January 2000 till February 2021 at Seth G.S. Medical college and KEMhospital, Parel, Mumbai.

Thiswill encompass clinical features, biochemical investigations, imaging,management, and outcome details.

METHODOLOGY:

Thisis a retrospective study conducted at a tertiary health care center. Data willbe collected (both baseline and follow up) from medical records of patients withprecociouspuberty. The clinical features (age of presentation, age of diagnosis, gender,family history, symptoms, examination findings), biochemical characteristics (FSH,LH, testosterone, estradiol, 17 OHP, basal cortisol, TFT, beta HCG, GnRHstimulation test), radiological investigations (Xray, USG pelvis, MRI brain etc.)will be recorded.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 20.00 Year(s)(—)
性别
All

入选标准

  • Patients with precocious puberty.

排除标准

  • heterosexual forms of precocious puberty.

结局指标

主要结局

NOT APPLICABLE

时间窗: NOT APPLICABLE

次要结局

  • NOT APPLICABLE(NOT APPLICABLE)

研究者

发起方
未提供

研究点 (1)

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