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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03545542
Date of registration:	07/05/2018
Prospective Registration:	Yes
Primary sponsor:	Medical University of Graz
Public title:	Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma
Scientific title:	Investigating the Microbiome and Volatile Organic Compound Profile of Children With Neuroblastoma - a Pilot Study
Date of first enrolment:	May 7, 2018
Target sample size:	20
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03545542
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Austria

Contacts

Name:	Christoph Castellani, MD
Address:
Telephone:	+43/316/385
Email:	christoph.castellani@medunigraz.at
Affiliation:

Name:	Christoph Castellani, MD
Address:
Telephone:
Email:
Affiliation:	Department of Paediatric and Adolescent Surgery, Medical University of Graz, Austria

Name:	Christoph Castellani, MD
Address:
Telephone:	+43/316/385
Email:	christoph.castellani@medunigraz.at
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 2-8 years

- Neuroblastoma group: verified neuroblastoma

- Control group: absence of pulmonary or gastro-intestinal disease

- Written parental informed consent obtained

Exclusion Criteria:

- Active gastro-intestinal or pulmonary disease

- Antibiotic or probiotic treatment within 3 weeks before sampling

- Negative parental informed consent

Age minimum: 1 Month
Age maximum: 8 Years
Gender: All

Health Condition(s) or Problem(s) studied

Microbial Colonization

Children, Only

Neuroblastoma

Intervention(s)

Diagnostic Test: Fecal volatile organic compounds under chemotherapy

Diagnostic Test: Breath volatile organic compounds under chemotherapy

Diagnostic Test: Final breath volatile organic compounds

Diagnostic Test: Final microbiome

Diagnostic Test: Microbiome under chemotherapy

Diagnostic Test: Initial breath volatile organic compounds

Diagnostic Test: Final fecal volatile organic compounds

Diagnostic Test: Initial fecal microbiome

Diagnostic Test: Initial fecal volatile organic compounds

Primary Outcome(s)

Change of alpha and beta diversity, relative abundance of fecal bacteria at different levels (phylum, class, order, family and genus levels) under chemotherapy in the neuroblastoma group [Time Frame: Within 48h after diagnosis, before initiation of chemotherapy; 1 week after each chemotherapy cycle and 3 weeks after the end of chemotherapy.]

Difference of alpha and beta diversity, relative abundance of fecal bacteria at different levels (phylum, class, order, family and genus levels) between neuroblastoma and control group [Time Frame: Neuroblastoma group: within 48h after diagnosis, before initiation of chemotherapy. Control group: within 24h after obtaining informed consent.]

Secondary Outcome(s)

Difference of stool volatile organic compounds between neuroblastoma and control group. [Time Frame: Neuroblastoma group: within 48h after diagnosis. Control group: within 24h after obtaining informed consent.]

Change of anthropometric data under chemotherapy in the neuroblastoma group [Time Frame: Within 48h after diagnosis, before initiation of chemotherapy; 7 days after completion of each chemotherapy cycle and 3 weeks after the end of chemotherapy.]

Change of breath volatile organic compounds under chemotherapy in the neuroblastoma group. [Time Frame: Within 48h after diagnosis, before initiation of chemotherapy; 1 week after each chemotherapy cycle and 3 weeks after the end of chemotherapy.]

Change of stool volatile organic compounds under chemotherapy in the neuroblastoma group. [Time Frame: Within 48h after diagnosis, before initiation of chemotherapy; 1 week after each chemotherapy cycle and 3 weeks after the end of chemotherapy.]

Difference of anthropometric data between neuroblastoma and control group. [Time Frame: Neuroblastoma group: within 48h after diagnosis. Control group: within 24h after obtaining informed consent.]

Change of mucositis score under chemotherapy in the neuroblastoma group. [Time Frame: Within 48h after diagnosis, before initiation of chemotherapy; 7 days after completion of each chemotherapy cycle and 3 weeks after the end of chemotherapy.]

Difference of breath volatile organic compounds between neuroblastoma and control group. [Time Frame: Neuroblastoma group: within 48h after diagnosis. Control group: within 24h after obtaining informed consent.]

Secondary ID(s)

0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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