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CTRI Number  CTRI/2020/05/025080 [Registered on: 08/05/2020] Trial Registered Prospectively
Last Modified On: 06/04/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   RETROSPECTIVE 
Study Design  Other 
Public Title of Study   Retrospective analysis of the phenotypic and genotypic spectrum of mutation proven POU1F1 patients and to compare them with the published literature. 
Scientific Title of Study   Retrospective analysis of the phenotypic and genotypic spectrum of mutation proven POU1F1 patients and to compare them with the published literature. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anurag Ranjan Lila 
Designation  Associate Professor 
Affiliation  KEM Hospital, Department of Endocrinology 
Address  Department of Endocrinology, OPD 103, First Floor, OPD Building, Seth GSMC and KEM Hospital, Parel, Mumbai. Acharya Donde Marg, Parel, Mumbai - 400012. Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9323065346  
Fax    
Email  anuraglila@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anurag Ranjan Lila 
Designation  Associate Professor 
Affiliation  KEM Hospital, Department of Endocrinology 
Address  Department of Endocrinology, OPD 103, First Floor, OPD Building, Seth GSMC and KEM Hospital, Parel, Mumbai. Acharya Donde Marg, Parel, Mumbai - 400012. Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9323065346  
Fax    
Email  anuraglila@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anurag Ranjan Lila 
Designation  Associate Professor 
Affiliation  KEM Hospital, Department of Endocrinology 
Address  Department of Endocrinology, OPD 103, First Floor, OPD Building, Seth GSMC and KEM Hospital, Parel, Mumbai. Acharya Donde Marg, Parel, Mumbai - 400012. Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9323065346  
Fax    
Email  anuraglila@gmail.com  
 
Source of Monetary or Material Support  
Department of Endocrinology, Seth G.S.Medical college and KEM hospital,Acharya Dhonde marg, Parel,Mumbai,400012 
 
Primary Sponsor  
Name  Department of Endocrinology 
Address  Department of Endocrinology, Seth G.S.Medical college and KEM hospital, Acharya Dhonde marg, Parel,Mumbai 400012 
Type of Sponsor  Other [Department academic study] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anurag Lila  KEM hospital  Department of Endocrinology, Seth G.S.Medical college and KEM hospital, Acharya Dhonde marg,Parel,Mumbai, MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA 
9323065346

anuraglila@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E230||Hypopituitarism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients with growth hormone who visited the Endocrine OPD from Jan 2002 till Dec 2019. 
 
ExclusionCriteria 
Details  1.Mutations other than POU1F1.
2.Inadequate data
3.Insufficient Diagnosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
clinical co-relation of Genotype and Phenotype in POU1F1 Patient.  01 Year 
 
Secondary Outcome  
Outcome  TimePoints 
None  01 Year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/05/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Introduction:

Combined pituitary hormone Deficiency (CPHD) is a condition classically characterized by a deficiency of growth hormone (GH) and at least one other pituitary hormone. The prevalence of CPHD is estimated to be 1 in 8000 individuals worldwide.1 POU1F1 is one of the earliest gene described in 1990 in pathogenesis of CPHD with  prevalence of 2.8% in CPHD patients with 84 % having no causative gene found.2 First described in1990 Snell (dw/dw) and Jackson (dwj/dwj) dwarf mice, harboring POU1F1 mutations, presented with greatly reduced size and hypothyroidism.3 POU1F1 mutation carriers display hypoplastic or normal adenohypophysis with normal pituitary stalk and posterior pituitary. 4,5,6

A total of 30 different variants in POU1F1 have been described, and they are generally recessive with pituitary hypoplasia and CPHD. Herein, we plan to study our cohort of patients and do a systematic review of the published literature, with the aim of analysing phenotypic and genotypic spectrum of POU1F1 patients worldwide.

 

Aim:  

To study thephenotypic and genotypic spectrum of mutation proven POU1F1 patients in our cohort and to compare them with the published literature.

Type of study: Retrospective

Methodology:

A retrospective case record analysis of patients diagnosed with Growth Hormone deficiency or Combined Pituitary Hormone Deficiency of POU1F1 mutation proven patients (cohort 1)from Jan 2002 - Dec 2019 will be conducted at Endocrine OPD of a tertiary health care centre.Data will be collected (both baseline and follow up) from medical record of patients all genetically diagnosed cases of POU1F1.Patient details including birth history, age at present, family history of short stature and consanguinity, anthropometric data (Patient height, patient height SDS, patient weight, patient weight SDS, US:LS Ratio, arm span, mother’s height, mother’s height SDS, father’s height, father’s height SDS, MPH, MPH SDS), SMR, phenotypic features associated with growth hormone deficiency, biochemical investigations (IGF-1, IGFBP3, T3, T4, FT3, FT4, TSH, 8am cortisol, prolactin, FSH, LH, testosterone), peak GH concentration based on GH stimulation tests (clonidine stimulation test, insulin tolerance test or glucagon stimulation test), skeletal maturity and MRI findings (anterior pituitary height, location of posterior pituitary, morphology of pituitary stalk, optic nerves and midline brain structures) will be recorded in an approved case record form. Additionally, anthropometric data, SMR, skeletal maturity and biochemical investigations will be documented for follow-up visits. Approximately 20 case records will be reviewed for this study. Genetic analysis was offered to patients with Growth Hormone deficiency at the department as a standard of care. Some patients have borne the cost of genetic analysis, while some have been offered help through donations or trust funds. The genetic testing from K.E.M is usually out sourced to Medgenome Laboratories.

Cohort 2 would comprise of systematic review of published literature (up to Dec 2019) will be done on MEDLINE and Scopus search engines employing following search terms: POU1F1, pit 1, CPHD and GHD.

All original and review articles published in English were reviewed for inclusion. Only publications describing mutation proven POU1F1 will be included. A secondary search for relevant publications was carried out by hand searching through the reference lists of selected publications.

Definitions and Cut offs:

Diagnosis of GHD is based on peak GH concentration < 7ng/ml in children and <3ng/ml in adults (>18 years) on at-least one GH stimulation test (clonidine stimulation test, insulin tolerance test or glucagon stimulation test) with low serum IGF-1 levels.

Hypothyroidism is defined as low serum free/total T4 with low or inappropriately normal TSH levels.

Hypocortisolism is defined as 8.00am cortisol 5μg/dl and/or serum cortisol < 18 μg/dl at the time of hypoglycaemia during insulin tolerance test (where available).

Hypogonadism is defined as the clinical absence pubertal onset/progression with low or inappropriately normal serum FSH and LH levels in individuals with bone age > 13 years in females and >14 years in males.

Hypoplastic pituitary is defined as less than -2 SD of normal when maximum height of the pituitary is measured perpendicular to the sella turcica.

Inclusion Criteria:

All patients with growth hormone who visited the Endocrine OPD from Jan 2002 till Dec 2019.

Exclusion Criteria:

1.      Mutations other than POU1F1.

2.      Inadequate data

3.      Insufficient Diagnosis


Statistical analysis:

All categorical variables will be expressed in actual numbers and percentages. All continuous variables will be expressed as mean and standard deviation. Categorical parameters will be compared with chi square test. P value < 0.05 will be considered statistically significant.





 

 


 
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