Oi Kwan Joyce Chung, Dr

This study aims to translate the original English version of Resilience Scale for Children (RS10) into traditional Chinese. It will then test the psychometric properties of the newly translated RS10.

It has been well documented that cancer and its treatment may have adverse effects on the physical and psychological well-being of children with cancer. Such adverse effects may start from diagnosis and continue for months or even years after the completion of therapy. Cancer and its treatments may also have long-term effects on the psychological well-being of children with cancer, such as decreased self-esteem, increased anxiety and depression that can adversely affect their quality of life.

Numerous studies indicated that resilience effectively prevents the development of mental health problems and is associated with positive mental health outcomes in children and adolescents, such as reduced levels of anxiety, depression and obsessive compulsive symptoms. Assessing resilience in children with cancer is therefore crucial for a thorough understanding of their responses to stress and adversity, which is an essential prerequisite for the design of an appropriate psychological intervention to enhance their resilience and foster the development of their coping mechanisms and positive mental well-being.

This study aims to translate the original English version of Resilience Scale for Children (RS10) into traditional Chinese. It will then test the psychometric properties of the newly translated RS10. In addition, the factorial structure of RS10 will be examined using confirmatory factor analysis (CFA).

Psychometric Evaluation of the Chinese Version of the Resilience Scale-10 for Cancer Children

The Resilience Scale for Children (RS10) was developed to measure a child's capacity to respond to the life changes. The RS10 measures the child's resilience capacity along five core elements: (1) Sense of purpose and meaning, (2) Authenticity, (3) Equanimity, (4) Self-Reliance, and (5) Perseverance.

The subjects' depressive symptoms will be assessed using the Chinese version of the CES-DC. The CES-DC comprises 20 fully standardized items to evaluate depressive symptoms. All items are evaluated on a four-point self-report scale in relation to their incidence during the last week, which were scored from 0 to 3, with total possible scores ranging from 0 to 60, with higher scores indicating greater symptomatology.

The subjects' self-esteem will be assessed using the Chinese version of the RSES. The RSES is designed to measure the global self-esteem of children and adolescents. The scale comprises 10 items, rated using a 4-point Likert scale ranging from 1 to 4, with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem.

The University of Hong Kong

Symptoms and General Pathology

All Conditions

Disease Susceptibility

Genetic Predisposition to Disease

Disease Attributes

* Collection of blood sample or saliva
* Collection of a tumor sample taken before the participation of the patient in study
* Collection of blood sample if tumor sample is not available

Collection of blood sample or saliva

Collection of a tumor sample taken before the participation of the patient in study

Collection of blood sample if tumor sample is not available

Elsa BERARDI

Catherine DEVOLDERE, MD

Isabelle PELLIER, PU-PH

Virginie BUBIEN, MD

Julie TINAT, MD

Liana-Stefania CARAUSU, MD

Christine FRANCANNET, MD

Laurence OLIVIER-FAIVRE, PU-PH

Dominique PLANTAZ, PU-PH

Sophie LEJEUNE, MD

Christophe PIGUET, MD

Nadege CORRADINI, MD

Delphine SIGAUDY, MD

Carole COZE, MD

Stéphanie HAOUY, MD

Bruno LEHEUP, MD

Bertrand ISIDOR, MD

Marilyne DUPUY, MD

Franck BOURDEAUT, MD

Hélène MARTELLI, PU-PH

Sabine SARNACKI, PU-PH

Vincent COULOIGNER, PU-PH

Hélène BOUTROUX, MD

Philippe DENIZEAU, MD

Pascale SCHNEIDER, PU-PH

Jean-Louis STEPHAN, MD

Catherine PAILLARD, PU-PH

Marion GILLIBERT-YVERT, MD

Léa GUERRINI-ROUSSEAU, MD

Yves REGUERRE, MD

Isabelle PELLIER, Pr

Other than high-dose radiation and previous chemotherapy, few strong risk factors have been identified as causes of childhood cancer. Geneticists estimate that 5 to 10% of all cancers diagnosed during the paediatric period occur in children born with a genetic mutation, increasing their lifetime risk of neoplasia. Such genetic risk is higher in children with congenital anomalies and specific genetic syndromes. Some germline genetic alterations are well known (e.g. P53 protein (P53), Neurofibromatosis type 1(NF1)), however many children with none of these mutations have clinical presentations that strongly suggest the involvement of a genetic predisposition. Comprehensive genetic testing for all such patients is an important factor for improving disease surveillance. Such opportunities are now available thanks to whole exome sequencing (WES). In oncology, an important clinical application of WES will be to routinely identify mutations associated with inherited cancer predispositions and to guide cancer risk-management decisions.

Our project is a national translational multicenter genetics study aimed at identifying genes involved in paediatric cancer predisposition by WES in a very select population of children with both developmental delay and cancer. Our project relies on the TED register (Tumeur Et Développement), an initiative by the French organisation SFCE (Société Française de lutte contre les Cancers et les leucémies de l'Enfant et de l'Adolescent) involving 30 child cancer units in France. This database includes the information of more than 500 paediatric cancer patients with congenital abnormalities. The investigators plan to sequence the germline and tumour exome of 100 patients with developmental delay in a trio-design consisting of 300 people and 100 tumours.

The investigators believe that the ExoCaRe project will provide answers to the genetic origins of certain particular childhood cancers. The ExoCaRe project relies on a genetic study to identify genetic risk factors for rare forms of childhood cancer and aims to establish more personalised treatment. It is aimed at improving genetic counselling for families and will be fully integrated in the genetic counselling process. The information provided by our study will be used to improve the management approach to an initial cancer by clarifying the risks of other cancers in related families. The investigators hope to identify new germline genes predisposing to cancer that will be of interest in understanding tumour biology.

-Primary objective : Our aim is to identify new mutations and genes involved in paediatric cancer predisposition associating developmental delay by WES of a sub-cohort of patients included in the TED database.

-Secondary objectives :

1. Describe inherited predisposition to cancer.
2. Improve genetic counselling processes.
3. Initiate clinical exome sequencing in childhood cancer treatment.

prospective multicenter study, not therapeutic,

EXOme Rare Cancers in Children (EXOCARE)

An Investigation of Susceptibility Genes for Rare Cancers in Children by Exome Sequencing

WES and RNA sequence data will be used to identify and characterise germline and somatic genetic variants of pathological significance and associated with the disease.

Descriptive statistics, such as counts and proportions of variants of pathological significance risk will be computed within each patient and family.

The deleterious mutations that the investigators will identify in genes related to childhood cancer predisposition will help to have a comprehensive framework of biological pathways involved in childhood cancer predisposition.

Success is defined by the combined successes of quality interpretable genomic data are generated from sequencing tumor and germline tissues, and communicating genomic test results to the primary oncologist and the patient and his/her parents.

Descriptive statistics, such as counts and proportions of success by clinical presentation of the disease, by cancer types, by features of developmental delay, and, by class of age.

University Hospital, Angers

Wounds and Injuries

Blood and Lymph Conditions

Behaviors and Mental Disorders

Rare Diseases

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Granulocytopenia

* Visit 1 : At inclusion (day 1 of chemotherapy treatment)
* Visit 2 : Onset of aplasia
* Visit 3a : day 1 of the 1st febrile aplasia
* Visit 3b : day 3 of the 1st febrile episode
* Visit 3c : day 8 of the 1st febrile episode
* Visit 4a : second febrile episode (after 7 days)
* Visit 4b : day 3 of the second febrile episode (after 7 days)

Collection of blood sample

Marianne ROUMY

Coralie MALLEBRANCHE, Dr

Febrile aplasia is a common occurrence in children/adults treated with chemotherapy for malignant blood diseases or solid cancers.

This acquired deficiency of immunity mainly causes susceptibility to bacterial and fungal infections, pathogens normally recognized by specific receptors of innate immunity (Pattern Recognition Receptor, PRR).

Thus, the febrile episodes in the context of post-chemotherapy neutropenia can be bacterial or fungal etiology, but can also frequently be related to viral infections, toxic phenomena or other etiologies. In the absence of a discriminating marker, treatment for all these children is based on early, broad-spectrum antibiotic therapy in hospital. Septic shock or even death by refractory septic shock remain, even if they are rare, real complications in pediatric oncology, requiring discriminatory markers for effective management, While trying to reduce the number and duration of hospitalizations for children at low risk for severe febrile aplasia.

It is therefore necessary to identify other markers allowing the earliest possible classification of episodes of febrile aplasia.

A previous study, conducted by our team, PTX3 and febrile aplasia, studied pentraxin 3 (PTX3), a soluble PRR of the pentraxin family that plays a key role in immune surveillance against pathogens. Preliminary results obtained from samples from a cohort of patients treated in adult hematology and pediatric onco-hematology support a prognostic character of PTX3 in the severity of aplasia, with higher elevations of serum protein during episodes of severe sepsis or septic shock (ongoing analyses and interpretations for the adult population). The available data to date on the pediatric cohort are insufficient to conclude on the value of using PTX3. The investigators therefore wish to create a new paediatric cohort, in order to evaluate the PTX3 levels for the paediatric population and also to perform the assay of a new marker, clusterin.

Clusterin (CLU) is an extracellular chaperone protein of constitutive expression. The Innate Immunity team of the National Institute of Health and Medical Research (INSERM) "1307-Scientific Research National Center (CNRS) 6075" unit has shown that Clu binds to extracellular histones and inhibits their inflammatory, thrombotic and cytotoxic properties. The investigators also observed (i) that in adults without severe sepsis neutropenics, low serum levels of Clu at intake and lack of normalization of rates are associated with higher mortality and (ii) Clu levels are inversely correlated with circulating histone levels. All these data suggest that Clu would have a protective role for histone-induced lesions during sepsis independently of antibiotic treatment, opening an innovative therapeutic pathway in the management of severe sepsis.

CluPPFeN is based on the hypothesis that, in a pediatric population with episodes of febrile aplasia, serum Clu and serum PTX3 levels would discriminate between febrile episodes caused by bacterial infection and other etiologies and, As a result, would reduce the consumption of antibiotics, which provide resistance, and the length of hospitalization.

-Primary objective :

Evaluate serum levels CLU levels during febrile neutropenia in children followed for cancer.

-Secondary objective :

1. Evaluate serum levels of CLU at the beginning of non-febrile aplasia and during a possible 2nd febrile peak
2. Evaluate serum PTX3 levels during febrile neutropenia in children followed for cancer
3. Explore the association between CLU, PTX3 and the severity of the aplasia episode
4. Evaluate the association between CLU and PTX3 levels and the type of pathogen found during febrile aplasia
5. Exploration of the diagnostic contribution of CLU and PTX3 in relation to other known parameters of inflammation (including C reactive protein (CRP), procalcitonin (PCT), fibrinogen, interleukin 1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-α), CXCL8, IL17)
6. Exploration of genetic polymorphisms predisposing to bacterial and fungal infections (including PTX3 and CLU gene polymorphisms) in the context of febrile aplasia

Clusterin, Ptx3 and Pediatric Febrile Neutropenia (CluPPFeN)

Evaluation of Serum Clusterin and Serum PTX3 Assay During Febrile Aplasia in Children Treated in Pediatric Oncology

Serum CLU levels will be estimated at day 1, day 3 and day 8 of febrile aplasia (PNN \< 500/mm3). These assessments will also be performed at day 1 of the aplasing chemotherapy course (prior to chemotherapy administration, this value will be considered the reference value). The unit of analysis will be the number of CLU samples included in each scheduled visit.

An estimate of CLU levels at the beginning of non-febrile aplasia (PNN \< 500/mm3) as well as after a second episode of fever (2nd febrile peak) beyond day 7 will be made. An estimate of serum CLU levels will also be made at day 3 of the 2nd febrile peak

Serum levels of PTX3 will be evaluated using the same pattern and assessment methods previously described for CLU.

Neoplasms

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

All subjects in the intervention group will receive a weekly 45-minute lesson, one-to-one musical training for 52 weeks.

a weekly 45-minute lesson, one-to-one musical training

Musical Training Program

Joyce Chung

We aim to conduct a feasibility study to determine the feasibility and suitability of implementing a musical training program for children surviving brain tumours. This study will demonstrate the feasibility of implementing a musical training program in improving the neurocognitive functioning of surviving brain tumours.

Brain tumour is the second most common childhood cancer in Hong Kong. Evidence shows that cancer and its treatments have long-term and lasting adverse effects on the neurocognitive functioning of paediatric brain tumour survivors, including the impairment of intellectual development and deficits in attention, working memory, processing speed and executive functions. There has been an increase in the use of musical training to promote the neuro-rehabilitation of patients suffering from stroke and Parkinson's disease, and to improve reading skills and academic achievement in young poor readers, and to enhance children's cognitive development. We conducted a randomized controlled trial (RCT) from 2017 to 2018 to examine the effectiveness of musical training on psychological outcomes and quality of life in Chinese paediatric brain tumour survivors. The results showed that participants who received a weekly 45-min lesson on musical training for 52 weeks (intervention group) reported statistically significant fewer depressive symptoms, higher levels of self-esteem, and better quality of life than those who received placebo intervention (control group) at 12-month demonstrating the effectiveness of musical training intervention. Nevertheless, it is unclear whether musical training can also be used to improve neurocognitive functioning, in particular the attention, processing speed, and executive functions of children surviving brain tumours.

The overall aim of this proposed study will be to assess the feasibility of a musical training program in improving the neurocognitive functioning of children surviving brain tumours. The objectives of this feasibility study are as follows:

1. To ascertain the feasibility of recruitment and data collection in the outpatient clinic of the Hong Kong Children's Hospital;
2. To assess the response and retention rates of the study;
3. To examine the content of the proposed musical training program for its appropriateness, comprehensiveness and duration to the target participants;
4. To evaluate the appropriateness and feasibility of using various assessment tools in measuring the intelligence, attention, processing speed and executive functions of the paediatric brain tumour survivors; and
5. To assess any changes in neurocognitive functioning of children surviving brain tumours after receiving musical training for 52 weeks.

Musical Training Programme to Improve Neurocognitive Functioning of Children Surviving Brain Tumours

Feasibility Study of a Musical Training Program in Improving the Neurocognitive Functioning of Children Surviving Brain Tumours

the proportion of subjects who are eligible and invited and consent to participate.

The proportion of subjects who complete the questionnaires and assessments at baseline and 12 months after starting the intervention

The proportion of subjects who complete the whole intervention from baseline to 12 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Psychometric Evaluation of the Chinese Version of the Resilience Scale-10 for Cancer Children	NCT03544190	Cancer Childhoo...		7 Years - 14 Years	The University of Hong Kong
EXOme Rare Cancers in Children (EXOCARE)	NCT03472807	Predisposition,... Cancer Childhoo... Development Del...	Collection of b... Collection of a... Collection of b...	-	University Hospital, Angers
Clusterin, Ptx3 and Pediatric Febrile Neutropenia (CluPPFeN)	NCT05584930	Cancer Childhoo... Febrile Neutrop...	Collection of b...	- 18 Years	University Hospital, Angers
Musical Training Programme to Improve Neurocognitive Functioning of Children Surviving Brain Tumours	NCT05202925	Cancer Childhoo... Brain Tumor	Musical Trainin...	7 Years - 16 Years	The Hong Kong Polytechnic University
Musical Training Programme to Improve Neurocognitive Functioning of Children Surviving Brain Tumours	NCT05202925	Cancer Childhoo... Brain Tumor	Musical Trainin...	7 Years - 16 Years	The Hong Kong Polytechnic University
Psychometric Evaluation of the Chinese Version of the Resilience Scale-10 for Cancer Children	NCT03544190	Cancer Childhoo...		7 Years - 14 Years	The University of Hong Kong
Clusterin, Ptx3 and Pediatric Febrile Neutropenia (CluPPFeN)	NCT05584930	Cancer Childhoo... Febrile Neutrop...	Collection of b...	- 18 Years	University Hospital, Angers

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