Infections

All Conditions

Symptoms and General Pathology

Neoplasms

Rare Diseases

Communicable Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Disease Attributes

Neuroepithelioma

10 children with neuroblastoma. Inclusion after verification of diagnosis and informed consent.

Sampling of fecal microbiome (Initial microbiome, microbiome under chemotherapy, final microbiome), fecal volatile organic compounds (initial fecal volatile organic compounds, fecal volatile organic compounds under chemotherapy and final fecal volatile organic compounds) and breath organic volatile compounds (initial breath organic compounds, breath volatile organic compounds under chemotherapy and final breath volatile organic compounds).

Samples will be taken after verifying diagnosis before initiation of chemotherapy, 1 week after completion of each cycle and 3 weeks after the end of chemotherapy.

10 children without gastro-intestinal or pulmonary disease as age and sex matched controls to the neuroblastoma group. Patients will be recruited from paediatric surgery. Inclusion after informed consent.

Sampling of fecal microbiome (initial fecal microbiome), fecal volatile organic compounds (initial fecal volatile organic compounds) and breath organic volatile compounds (initial breath volatile organic compounds).

Samples will be taken as age and sex matched controls for the neuroblastoma group. Sampling will be done once after obtaining informed consent.

Stool sampling for fecal microbiome analysis by 16S rDNA pyrosequencing. Neuroblastoma group and Control group.

Initial fecal microbiome

Volatile organic compound analysis of stool samples by gas chromatography/mass spectroscopy Neuroblastoma group and Control group.

Initial fecal volatile organic compounds

Breath sampling for organic compound analysis by gas chromatography/mass spectroscopy Neuroblastoma group and Control group.

Initial breath volatile organic compounds

Stool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to Société Internationale d´Onclogie Pediatrique Neuroblastoma Group (SIOPEN) guidelines

Microbiome under chemotherapy

Stool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines.

Neuroblastoma group

Fecal volatile organic compounds under chemotherapy

Breath sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines.

Neuroblastoma group

Breath volatile organic compounds under chemotherapy

Stool sampling 3 weeks after completion of chemotherapy Neuroblastoma group

Final microbiome

Final fecal volatile organic compounds

Breath sampling 3 weeks after completion of chemotherapy Neuroblastoma group

Final breath volatile organic compounds

Christoph Castellani, MD

Georg Singer, MD

Daniela Sperl, MD

Background: Malignant tumors may lead to a catabolic state with loss of muscle and adipose tissue. The full picture of catabolism is termed cachexia and is associated with significant morbidity and mortality of cancer patients. Although the full picture is rarely observed up to 50% of children with cancer suffer from significant malnourishment. Additionally to tumor-induced catabolism, side-effects of chemotherapy may be problematic for the patients. In this regard up to 60% of children suffer from gastrointestinal mucositis presenting with nausea, vomiting, diarrhea or constipation and abdominal pain. In the worst case, mucositis may lead to bacterial translocation with life-threatening inflammatory response. Clinically this may require a reduction of the dosage or the number of chemotherapy cycles resulting in reduced effectivity. Up to now the therapy of mucositis is only symptomatic. Recent research of the applicant has shown a significant reduction of Lactobacilli in mice with neuroblastoma (a malignant childhood tumor). The dysbiosis was associated with catabolism, increased gut permeability and inflammation. Astonishingly, chemotherapy alone also leads to a significant reduction of Lactobacilli compared to sham mice, which may be linked to the development of mucositis clinically. Overall, the intestinal microbiome seems to play an essential role in the development of tumor-associated catabolism and chemotherapy-induced mucositis.

Aim: The aim of this project is to determine if the changes in the intestinal microbiome observed in mice can also be seen in children with neuroblastoma.

Methods: One part of the study will include 10 children with neuroblastoma (inclusion after verification of the diagnosis) and 10 healthy controls. The fecal microbiome will be determined by 16S-ribosomal deoxyribonucleic acid (rDNA) pyrosequencing. Volatile organic compounds in the breath will be sampled and measured by Gas Chromatography/Mass Spectroscopy. A basic science human work package will address the question if there are differences.

In the second part serial investigations in children with neuroblastoma will assess whether or not these patients show alterations of the intestinal microbiome under chemotherapy.

Neuroblastoma group: Children with neuroblastoma enrolled after verification of diagnosis. Sampling before initiation of chemotherapy and under chemotherapy.

Control group: healthy children without gastro-intestinal or pulmonary disease recruited from paediatric surgery.

Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma

Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma - a Pilot Study

Alpha and beta diversity, relative bacterial abundance at different levels in percent.

Body weight (in kg) and height (in m) will be determined to calculate the body mass index (BMI in kg/m\^2).

Body weight (in kg) and height (in m) will be determined to calculate the Body mass index (BMI in kg/m\^2).

Assessment of the mucositis score according to the WHO criteria (WHO handbook for reporting results of cancer Treatment; WHO Offset publication no 48) The score contains 5 subitems which are evaluated separately. At the end a total score is derived by adding the results of all items.

Subitem 1: oral mucosa; range 0 (best) to 4 (worst) Subitem 2: nausea and vomiting; range from 0 (best) to 4 (worst) Subitem 3: diarrhea; range from 0 (best) to 4 (worst) Subitem 4: constipation; range from 0 (best) to 4 (worst) Subitem 5: abdominal pain; range from 0 (best) to 4 (worst)

Volatile organic compounds in ppb in the exhaled breath.

Volatile organic compounds in ppb in stool samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma	NCT03545542	Microbial Colon... Neuroblastoma Children, Only	Initial fecal m... Initial fecal v... Initial breath ... Microbiome unde... Fecal volatile ... Breath volatile... Final microbiom... Final fecal vol... Final breath vo...	1 Month - 8 Years	Medical University of Graz
Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma	NCT03545542	Microbial Colon... Neuroblastoma Children, Only	Initial fecal m... Initial fecal v... Initial breath ... Microbiome unde... Fecal volatile ... Breath volatile... Final microbiom... Final fecal vol... Final breath vo...	1 Month - 8 Years	Medical University of Graz

Spots Global Cancer Trial Database for final microbiome