跳至主要内容
临床试验/CTRI/2024/04/065718
CTRI/2024/04/065718已完成不适用

Chronic endocrinopathies among childhood cancer survivors exposed to radiotherapy

Not Applicable1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
To measure the growth and evaluate for any endocrine deficiencies among childhood cancer survivors exposed to radiotherapy.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Children whose parents deny consent.

结局指标

主要结局

To measure the growth and evaluate for any endocrine deficiencies among childhood cancer survivors exposed to radiotherapy.

时间窗: At the time of diagnosis, at the time of enrolment, and after 6 months.

次要结局

  • Not applicable(Not applicable)

研究者

申办方类型
Other [Not Applicable]
责任方
Principal Investigator
主要研究者

Pranay Agarwal

Kasturba Medical College, MAHE, Manipal

研究点 (1)

Loading locations...

相似试验

尚未招募
Unknown
Assessment of hormonal problems among children less than 18 years who have recovered from cancer.
CTRI/2024/04/065718ot Applicable
招募中
不适用
Malignant endocrine tumors in childhood and adolescenceC73D35D44.0D44.6D44.7D44.8C74C75C75.8C80D13C25C18C34C34.2C37C17C17.3C53C54Malignant neoplasm of thyroid glandBenign neoplasm of other and unspecified endocrine glandsThyroid glandCarotid bodyAortic body and other paragangliaPluriglandular involvementMalignant neoplasm of adrenal glandMalignant neoplasm of other endocrine glands and related structuresPluriglandular involvement, unspecifiedMalignant neoplasm, without specification of siteBenign neoplasm of other and ill-defined parts of digestive systemMalignant neoplasm of pancreasMalignant neoplasm of colonMalignant neoplasm of bronchus and lungMiddle lobe, bronchus or lungMalignant neoplasm of thymusMalignant neoplasm of small intestineMalignant neoplasm of cervix uteriMalignant neoplasm of corpus uteriMeckel diverticulum
DRKS00026731niversitätskinderklinik200
招募中
不适用
KETO-TUMOR: a Study on Brain Tumors and Central Obesity
NCT07396896Meyer Children's Hospital IRCCS30
招募中
不适用
Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Microscopy
NCT07313878University of Erlangen-Nürnberg Medical School30
尚未招募
不适用
Correlation Between Nutritional Status of Childhood Neurological Tumors and Quality of Life
NCT07264023Nanfang Hospital, Southern Medical University93
Assessment of hormonal problems among children less... | 临床试验