ClinicalTrials.gov
ClinicalTrials.gov Menu

Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02464098
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.


Condition or disease
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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients
Actual Study Start Date : November 19, 2015
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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



Primary Outcome Measures :
  1. Frequency by pathogen type of infectious pathogens [ Time Frame: at 12 months ]
    Descriptive statistics of infectious pathogens identified in diarrheal stools from PCR testing will be summarized.

  2. Proportion by pathogen type of infectious pathogens [ Time Frame: at 12 months ]
    Descriptive statistics of infectious pathogens identified in diarrheal stools from PCR testing will be summarized.


Secondary Outcome Measures :
  1. Frequency of symptoms [ Time Frame: at 12 months ]
    Descriptive statistics of symptoms, clinical course, morbidity and mortality in patients with diarrhea will be summarized.

  2. Proportion of symptoms [ Time Frame: at 12 months ]
    Descriptive statistics of symptoms, clinical course, morbidity and mortality in patients with diarrhea will be summarized.

  3. Number of infectious pathogens identified by multiplex PCR assay versus standard tests [ Time Frame: at 12 months ]
    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.


Biospecimen Retention:   Samples With DNA
All stool, blood and respiratory samples will be saved frozen for future testing.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464098


Contacts
Contact: Randall T. Hayden, MD 866-278-5833 referralinfo@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Randall T. Hayden, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Randall T. Hayden, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Randall T. Hayden, MD St. Jude Children's Research Hospital

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02464098     History of Changes
Other Study ID Numbers: EPIGUT
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Hematological Malignancies
Solid Tumors
Hematopoietic Stem Cell Transplantation (HSCT)
Childhood Cancer
Polymerase Chain Reaction (PCR)

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms