Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Influenza, Human

Virus Diseases

Communicable Diseases

Respiratory Tract Infections

Orthomyxoviridae Infections

RNA Virus Infections

Respiratory Tract Diseases

Children and young adults identified as having influenza infections by the St. Jude Children's Research Hospital diagnostic microbiology will be approached to participate in the study. Biological samples will be collected on Day 0 within 72 hours of the diagnosis of influenza, and at 7, 14, 21, and 28 days later.

Interventions: Symptom checklist, Blood sample, Nasal swab, Oropharyngeal swab, Stool sample.

Blood samples will be drawn and analyzed at Day 0, 7, 14, 21, and 28

Blood sample

Nasal swab

Oropharyngeal swab

Stool sample

Symptom checklist

Elisabeth E. Adderson, MD, MSc

The purpose of the proposed study is to gather critical information that may be useful in designing effective prevention and treatment strategies for control of seasonal influenza and an influenza pandemic. In particular, the critical questions are related to the virus' ability to adapt to efficient replication and spread in humans.

Influenza is a contagious respiratory illness caused by influenza A and B viruses. Influenza infections result in about 230,000 hospitalizations and 36,000 deaths annually in the United States. Children with cancer are more likely to have serious influenza and complications than those who have no underlying medical problems. They are also more likely to have prolonged influenza illnesses and to shed influenza viruses from their noses for long periods of time (sometimes for months). Recent studies suggest that influenza viruses may also be carried and shed from the gastrointestinal tract. New types of influenza viruses emerge frequently through mutations that occur when the viruses replicate. These mutations allow the virus to escape from killing by the immune system and are, in large part, responsible for seasonal epidemics of influenza that occur in the fall or winter months. It is possible that viruses can mutate when they are carried in the respiratory or gastrointestinal tracts for long periods, potentially giving rise to viruses that spread more easily to other persons, cause more severe disease, lead to new influenza epidemics or make the viruses resistant to drugs used to treat influenza.

Researchers at St. Jude Children's Research Hospital want to learn about how influenza viruses mutate in immunocompromised children. They will investigate how long children with cancer carry influenza viruses in their nose, throat and gastrointestinal tract and the characteristics of any mutations that are found in these viruses.

Participants will have nasal, oral and stool specimens obtained at the time they are diagnosed with influenza infections, and 7, 14, 21 and 28 days later. The genome of influenza viruses that are isolated from these participants will be sequenced and compared to one another and to standard influenza strains.

PRIMARY OBJECTIVE:

* To determine the proportion of pediatric oncology patients with nasal and oropharyngeal shedding of influenza viruses at 7, 14, 21 and 28 days following the diagnosis of infection.

SECONDARY OBJECTIVES:

* To determine the proportion of gastrointestinal shedding of human influenza viruses.
* To determine the frequency and pattern of mutations in influenza viruses isolated from pediatric oncology patients.
* To explore the biological consequences of mutations in influenza viruses isolated from pediatric oncology patients.

A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with nasal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of pediatric oncology patients with oropharyngeal shedding of influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of gastrointestinal shedding of human influenza viruses and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided. Frequency of gastrointestinal shedding of human influenza virus and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as proportion of human influenza viruses with mutations and its 95% confidence interval at days 7, 14, 21, and 28 days will be provided.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the type of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days will be provided to show the pattern of mutations. Genetic variants are defined to meet a minimum minor allele frequency of 20%.

Day 0 is collected within 72 hours of diagnosis of influenza. Descriptive statistics, such as the proportion of mutations observed in human influenza viruses at days 7, 14, 21, and 28 days that are associated with antiviral resistance will be provided to show the biological consequences. Two-sample t-tests or Wilcoxon rank-sum tests will be performed as appropriate to compare isolates to parental influenza isolates from the same patients.

St. Jude Children's Research Hospital

Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently inserted less than one inch into the anterior nare (nostril) until resistance is met at turbinate. Then it is rotated several times against nasal wall and repeated in other nostril using the same swab.

Nasal Swab

The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently rubbed along the inside of the participant's cheek for 5-10 seconds.

Oral Swab

A stool collection kit will be sent home with each participant. It will include instructions on how to collect the stool specimen and how to return the kit.

Stool Collection

Study of microbial communities found in and on the human body.

Microbiome analysis

Secure, long term storage of an individual's genetic material.

DNA Banking

Gentle rubbing of the swab will be applied to the skin on the dorsal part of the hand.

Skin Swab

Taher Abu Hejleh, MBBS

To characterize the fecal, skin, nasal and oral microbiome and metabolome in patients with lung cancer and other malignancies, and correlate to treatment response and toxicities of various therapies including immunotherapy, chemotherapy and targeted therapy, etc.

Patients will be asked to provide nasal, oral and skin swabs, as well as stool samples during their regular clinic visits, at the baseline before desired therapy is given, and at the time when treatment is changed due to either disease progression or unbearable toxicities leading to treatment stop/change. If treatment stop/held is due to toxicities, a 3rd set of samples will be collected when toxicities reduce to less than grade 1. The samples will be subjected to DNA extraction followed by 16S rRNA and/or shotgun sequencing metagenomic analysis. The data will be correlated to clinical response from treatments, toxicities, clinical data (use of antibiotics, PPIs, lab parameters, etc.) and tissue genetic/immunological characteristics (mutations, PDL1 expression, etc.) for review of response. This is not data to be used for treatment of these subjects.

Bacterial DNA will be isolated from oral, skin, and nasal swabs, as well as stool samples. The extracted DNA will be subsequently used for microbiome analysis.

Microbiome in Lung Cancer and Other Malignancies

The Role of Microbiome in Lung Cancer and Other Malignancies

Bacterial DNA will be isolated from stool/swab samples using standard protocol. Fecal micobiota will be examined based on an 16S rRNA amplicon.

Correlate data from samples with patient clinical information regarding overall response rates.

Record from each clinical visit the AEs from immunotherapy or its combination with chemotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents	NCT02352389	Influenza, Huma...	Blood sample Nasal swab Oropharyngeal s... Stool sample Symptom checkli...	- 21 Years	St. Jude Children's Research Hospital
Microbiome in Lung Cancer and Other Malignancies	NCT03688347	Lung Cancer Cancer Malignancy	Nasal Swab Oral Swab Stool Collectio... Microbiome anal... DNA Banking Skin Swab	18 Years - 100 Years	University of Iowa
A Pilot Study of Influenza Viruses Isolated From Immunocompromised Children and Adolescents	NCT02352389	Influenza, Huma...	Blood sample Nasal swab Oropharyngeal s... Stool sample Symptom checkli...	- 21 Years	St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for nasal swab

Every month we try and update this database with for nasal swab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nasal swab

Every month we try and update this database with for nasal swab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nasal swab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.