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CTRI Number  CTRI/2024/04/065718 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 25/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assessment of hormonal problems among children less than 18 years who have recovered from cancer. 
Scientific Title of Study   Chronic endocrinopathies among childhood cancer survivors exposed to radiotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranay Agarwal 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Paediatrics, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7838805882  
Fax    
Email  pranayagarwal10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Koushik H 
Designation  Associate Professor, Department of Paediatrics 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Paediatrics, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9242308804  
Fax    
Email  koushik.h@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Emine Rahiman 
Designation  Assistant Professor, Division of Paediatric Hematology and Oncology,  
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Division of Paediatric Hematology and Oncology, Ground Floor, Women and Child Block,Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9878169259  
Fax    
Email  emine.rahiman@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India 
 
Primary Sponsor  
Name  Not Applicable 
Address  Not applicable 
Type of Sponsor  Other [Not Applicable] 
 
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 Pranay Agarwal  Kasturba Hospital  Department of Paediatrics, Women and Child Block, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka
Udupi
KARNATAKA 
7838805882

pranayagarwal10@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E349||Endocrine disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All childhood cancer survivors, less than 18 years age, who have been exposed to cranial/craniospinal/total body irradiation/ neck /pelvic radiotherapy at least 1 year back. 
 
ExclusionCriteria 
Details  Children whose parents deny consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the growth and evaluate for any endocrine deficiencies among childhood cancer survivors exposed to radiotherapy.  At the time of diagnosis, at the time of enrolment, and after 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) 28/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
All childhood cancer survivors, <18 years age, who have been exposed to cranial/craniospinal/total body irradiation/ neck /pelvic radiotherapy at least 1 year back will be screened for endocrinopathies, as part of standard of care. Recruitment will take place from the Paediatric Endocrinology Clinic, Department of Paediatrics, Kasturba Medical College, Manipal, and from the Division of Paediatric Hematology and Oncology, Kasturba Medical College, Manipal. Informed consent will be obtained from the parents of the study participants. Assent for older children (12 years and above) will be additionally taken, apart from their parents consent. Details of primary diagnosis, detailed anthropometry, examination will be documented in predesigned proforma. Details of treatment received, chemotherapy regimen, surgery (if underwent), radiation dose, duration, site, and fractions will be documented. GROWTH ASSESSMENT-Height at enrolment will be compared with sex and age matched growth chart and mid parental height. Height velocity <25th centile for age, sex, population (as measured on HV charts by Khadilkar et al) indicative of growth failure. Height < 3rd centile/<2SD – will be considered as short stature. Body segments will be compared to age-appropriate norms. Height velocity will be checked after 6 months. In cases of growth failure or short-stature growth hormone stimulation test will be done. THYROID ASSESSMENT TFT will be done at enrolment and interpreted. ACTH/CORTISOL AXIS At enrolment, 8AM cortisol will be done. If <20 microgram/dl, post ACTH cortisol will be collected. After ACTH stimulation: >20microgram/dl-normal, if <20 microgram/dl hypocortisolism. PUBERTAL ASSESSMENT –Delayed puberty – No thelarche by 13 years/Testicular volume <4ml by 14 years. Whenever delayed puberty is suspected, 8 AM LH/FSH/Testosterone/Estradiol, USG pelvis will be sent and interpreted. Arrested puberty - Among those who are already into puberty, not progressing into subsequent stage of puberty over 6 months. CCS with arrested puberty will be evaluated in a similar line as delayed puberty. Precocious puberty – Thelarche at <8 years/Testicular volume ≥4 ml < 9 years. LH/FSH/Testosterone/Estradiol, USG pelvis will be done and interpreted. In case of obesity(>5 years, BMI >27 adult equivalent centiles, overweight-BMI>23 adult equivalent centiles as per IAP growth charts, <5 years, Overweight - weight/height- +2 to +3SD, Obesity- >+3SD, as per WHO MGRS charts) – Fasting blood sugar, fasting lipid profile, Waist circumference (measured at the mid-point between the subcostal margin and iliac crest), Hip circumference (largest circumference around hips), Waist Hip ratio will be measured, and diagnosis of metabolic syndrome will be made, based on International Obesity Task Force (IOTF) criteria. Metabolic syndrome will be considered if the child has central obesity and meets the criteria for any 2 of the other 4 parameters: Triglycerides, HDL-C, BP, Glucose. Children will be followed up 6 months later to measure their height and ascertain their height velocity.
 
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