| 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
|
|
|
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
|
|
|
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. |