Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients

NCT02464098 | Completed

• 1 other identifier: EPIGUT
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Diarrhea is a common problem in the pediatric population. Children with cancer are especially at increased risk for gastrointestinal infection-related morbidity and mortality due to their ongoing immunosuppression. However, the epidemiology of diarrheal illnesses in immunocompromised children is poorly understood. In the past, many or most cases of gastroenteritis have gone undiagnosed, largely due to a lack of sensitive diagnostic tests and a presumption that a large proportion of cases are due to treatment, rather than infections. The availability of new diagnostic tests that detect many gastrointestinal pathogens simultaneously offers the first opportunity to gain a comprehensive picture of the causes of infectious diarrhea in children with cancer. Researchers at St. Jude Children's Research Hospital want to learn about the epidemiology of diarrheal diseases in pediatric oncology patients utilizing broadly multiplexed, automated PCR.

Conditions

Diarrhea

Keywords

Hematological Malignancies; Solid Tumors; Hematopoietic Stem Cell Transplantation (HSCT); Childhood Cancer; Polymerase Chain Reaction (PCR)

Outcome Measures

Primary Outcomes (2)

• Frequency by pathogen type of infectious pathogens

  Descriptive statistics of infectious pathogens identified in diarrheal stools from PCR testing will be summarized.

  at 12 months

• Proportion by pathogen type of infectious pathogens

  Descriptive statistics of infectious pathogens identified in diarrheal stools from PCR testing will be summarized.

  at 12 months

Secondary Outcomes (3)

• Frequency of symptoms

  at 12 months

• Proportion of symptoms

  at 12 months

• Number of infectious pathogens identified by multiplex PCR assay versus standard tests

  at 12 months

Study Arms (2)

Group 1

Participants with diagnosis of hematological malignancy or solid tumor.

Group 2

Participants undergoing hematopoietic stem cell transplantation (HSCT).

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be pediatric oncology patients including patients with recent diagnoses of solid tumor or hematologic malignancy, or patients undergoing hematopoietic stem cell transplant.

You may qualify if:

• Equal to or less than 18 years of age.
• GROUP 1: Patients diagnosed in the preceding 14 days with confirmed diagnosis at St. Jude of a new hematological malignancy or solid tumor in the preceding 14 days, OR patients diagnosed with a new hematological malignancy or solid tumor and has initiated chemotherapy within the previous 72 hours from enrollment.
• GROUP 2: Patients scheduled to receive conditioning for hematopoietic stem cell transplant (HSCT) in the subsequent 7 days.
• Parent or legal guardian willing and able to give informed consent and comply with study requirements.
• Anticipated to be available for all study visits.

You may not qualify if:

• Patients from GROUP 1 (diagnosed in the preceding 14 days with a new hematological malignancy or solid tumor) who underwent HSCT in the previous 12 months.
• Has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Biospecimen

Retention: SAMPLES WITH DNA

All stool, blood and respiratory samples will be saved frozen for future testing.

MeSH Terms

Conditions

Diarrhea; Hematologic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Randall T. Hayden, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: November 19, 2015
• Primary Completion: November 6, 2019
• Study Completion: December 31, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Locations

US (1)