DiarrheaNCT02464098
Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients
An observational study of Diarrhea, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diarrhea
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2015to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Diarrhea
- Keywords
- Hematological Malignancies, Solid Tumors, Hematopoietic Stem Cell Transplantation (HSCT), Childhood Cancer, Polymerase Chain Reaction (PCR)
- Medical subject headings
- Diarrhea, Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants with diagnosis of hematological malignancy or solid tumor. | |
| Group 2 | Participants undergoing hematopoietic stem cell transplantation (HSCT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency by pathogen type of infectious pathogens
Descriptive statistics of infectious pathogens identified in diarrheal stools from PCR testing will be summarized.
Measured: 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.
Measured: at 12 months
Secondary outcomes (3)
Frequency of symptoms
Descriptive statistics of symptoms, clinical course, morbidity and mortality in patients with diarrhea will be summarized.
Measured: at 12 months
Proportion of symptoms
Descriptive statistics of symptoms, clinical course, morbidity and mortality in patients with diarrhea will be summarized.
Measured: 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.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start19 Nov 2015
- Primary completion6 Nov 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall T. Hayden, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464098
- Sponsor's protocol ID
- EPIGUT
- Status last verified
- Feb 2022
- First submitted
- 3 Jun 2015
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT02464098
- Acronym / sponsor ID
- EPIGUT
- Conditions
- Diarrhea
- Keywords
- Hematological Malignancies, Solid Tumors, Hematopoietic Stem Cell Transplantation (HSCT), Childhood Cancer, Polymerase Chain Reaction (PCR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Participants with diagnosis of hematological malignancy or solid tumor. |
| Group 2 | – | –Participants undergoing hematopoietic stem cell transplantation (HSCT). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Frequency of symptoms
Time frame: at 12 months
Proportion of symptoms
Time frame: at 12 months
Number of infectious pathogens identified by multiplex PCR assay versus standard tests
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall T. Hayden, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency by pathogen type of infectious pathogens (time frame: at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.