Underweight, Overweight, and Linear Growth of Childhood Cancer Patients - the Growth Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12,150
- 试验地点
- 11
- 主要终点
- Body Mass Index z-score, Height z-score, Weight z-score
研究概览
简要总结
The Growth study investigates nutritional status, BMI, and linear growth trajectories from birth to adulthood in childhood cancer patients and survivors. Specifically, it aims to identify the predictors driving these distinct growth and weight trajectories and evaluate the consistency of these findings across multiple European countries.
The study will make use of routine collected clinical data from oncology centres. Additional information about diagnoses, treatments, sociodemographic, and lifestyle data are obtained by linkages with disease and population registries, and with previously conducted questionnaire studies among survivors.
The study will provide insights into the nutritional status of childhood cancer patients and survivors and improve understanding of growth patterns in this population.
详细描述
Background: Underweight, overweight, and obesity occur frequently after childhood cancer diagnosis, and are common during and after cancer treatment. Childhood is a critical period for growth and development, which can be disrupted by cancer, treatment side effects, and increased physical demands. Poor nutritional status before and during treatment can in turn lead to complications, including infections, treatment-related toxicities, and reduced survival. However, scientific evidence on weight status and growth trajectories in childhood cancer patients and survivors remains limited. Previous studies have been small, focused on specific cancer types, or lacked objectively measured longitudinal data.
Electronic health records (EHRs) are routinely collected during clinical visits in hospitals. They provide an opportunity for clinical research, as they guarantee repeated and reliable records of clinically relevant factors, such as height, weight, and treatments received. In many European countries, such as Switzerland, Portugal, and Slovenia, hospitals and clinical data warehouses are making EHRs available and linkable to additional data sources (e.g., registries) via unique identifiers. The availability of standardized, semantically interoperable routine data from paediatric hospitals offers an unprecedented opportunity to investigate nutritional status across all childhood cancer types, treatment regimens, and critical time windows.
Objectives: The study will investigate nutritional status, body mass index (BMI), and linear growth trajectories from birth to adulthood in childhood cancer patients and survivors. It will identify predictors associated with distinct growth and weight trajectories and assess the consistency of findings across European countries.
Methods: The Growth study will collect routinely recorded sociodemographic, clinical, and anthropometric data from children and adolescents cancer patients (aged <20 years) diagnosed between 2004-2026, by linking data from the Swiss Childhood Cancer Registry (ChCR), the Swiss Childhood Cancer Survivor Study (SCCSS), the Swiss Federal Statistical Office (FSO), and oncology clinics in Switzerland, Portugal, and Slovenia. Deterministic linkage of data sources (ChCR, SCCSS, and oncology clinics) and probabilistic linkage with FSO data using patients' names, sex, and age will be performed.
The investigators will calculate age- and sex-specific z-scores for weight, height, and BMI based on country-specific and World Health Organization growth references. Group-based trajectory modelling will be applied to identify distinct growth and weight trajectories and to detect subgroups at increased risk of growth impairment. The investigators will use multinomial logistic regression models to identify predictors of impaired growth.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cancer at age <20 years
- •Diagnosed between 2004 and 2026
- •Treated in one of the participating cancer centres:
- •Switzerland: patients who visited one of the cancer centres in Switzerland: Aarau, Basel, Bellinzona, Bern, Geneva, Lausanne, Lucerne, St. Gallen, Zurich.
- •Portugal: patients diagnosed between 2012-2026 at the Portuguese paediatric oncology centres Instituto Português de Oncologia do Porto Francisco Gentil - IPO-PORTO or at the Instituto Português de Oncologia Francisco Gentil - IPOLFG.
- •Slovenia: patients diagnosed between 2011-2026 at the paediatric oncology clinic University Medical Center Ljubljana.
排除标准
- 未提供
研究组 & 干预措施
Childhood cancer patients and survivors
Children diagnosed with cancer before age 20 between 2004-2026, who visited at a participating clinic in Switzerland, Portugal, or Slovenia
结局指标
主要结局
Body Mass Index z-score, Height z-score, Weight z-score
时间窗: Through study completion, an expected average of 20 years
Body Mass Index calculated as weight in kg divided by height in meters, squared. z-scores calculated according to country-specific and international growth references. Height z-scores and weight z-scores calculated according to country-specific and international growth references.
次要结局
- Risk factors associated with underweight, overweight, and impaired linear growth in childhood cancer patients and survivors(Through study completion, an expected average of 20 years)
研究者
Fabiën Belle
PD Dr.
University of Bern