Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea

Detailed Description

This study plans to enroll participants in two groups:

• GROUP 1: Participants with hematologic malignancies or solid tumors.

  • Participants who agree to take part in this research study will have stool samples collected at diagnosis (baseline sample) and each month thereafter for 12 months from the time of enrollment. Stool samples will be screened for different types of microbes that may be present. For participants who develop diarrhea during these 12 months, three additional stool samples will be collected on Day 0, Day 7 and Day 14; two blood samples and mid-turbinate nasal swab will be collected as well on Day 0 and Day 7 of the first observed diarrheal episode to screen for additional microbes that may be the cause of the diarrhea.

• GROUP 2: Participants who are hematopoietic stem cell transplant (HSCT) patients.

  • Participants who agree to take part in this research study will have stool samples collected within one week prior to conditional chemotherapy (baseline sample) and weekly thereafter for a total of 16 weeks (pre- and early post-engraftment periods), followed by monthly for 8 months. Stool samples will be screened for different types of microbes that may be present. For participants who develop diarrhea, three additional stool samples will be collected on Day 0, Day 7 and Day 14; two blood samples and mid-turbinate nasal swab will be collected as well on Day 0 and Day 7 of the first observed diarrheal episode to screen for additional microbes that may be the cause of the diarrhea. For GROUP 2 participants, two diarrheal episodes will be studied per patient: the first diarrheal episode during the pre-engraftment period, and the first diarrheal episode during the post-engraftment period.

Participants with a change in cancer treatment plan enrolled on study: Group 1 participants who experience a change in their cancer treatment plan necessitating an allogeneic stem cell transplant will be taken off study for group 1 and offered the opportunity to consent to group 2 Participants who chooses to then enroll on group 2 will complete the 12-month study requirements as defined in the protocol for group 2 participants.

General health information from participant medical records and other health-related information about symptoms will also be obtained at the time of collection of the samples.

PRIMARY OBJECTIVE:

• To assess the prevalence of microbial pathogens in the stool of pediatric oncology patients with diarrheal illness.

SECONDARY OBJECTIVES:

• To describe the clinical course, symptomatology, morbidity and mortality associated with diarrheal diseases in pediatric oncology patients at St. Jude Children's Research Hospital.
• Evaluate the performance of the multiplex polymerase chain reaction (PCR) assay for the diagnosis of infectious diarrhea in comparison to the standard of care methods.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1; Participants with diagnosis of hematological malignancy or solid tumor.
Group 2; Participants undergoing hematopoietic stem cell transplantation (HSCT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of symptoms	Descriptive statistics of symptoms, clinical course, morbidity and mortality in patients with diarrhea will be summarized.	at 12 months
Proportion of symptoms	Descriptive statistics of symptoms, clinical course, morbidity and mortality in patients with diarrhea will be summarized.	at 12 months
Number of infectious pathogens identified by multiplex PCR assay versus standard tests	Infectious pathogens of diarrheal stools identified by the multiplex PCR assay will be compared descriptively against those identified by standard testing, and McNemar's test will be applied.	at 12 months

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Randall T. Hayden, MD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2015
• Primary Completion (Actual): November 6, 2019
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Childhood Cancer; Solid Tumors; Hematological Malignancies; Polymerase Chain Reaction (PCR); Hematopoietic Stem Cell Transplantation (HSCT)
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: EPIGUT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No