Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 10/6/2018 |
| Start Date: | November 19, 2015 |
| End Date: | December 31, 2021 |
| Contact: | Randall T. Hayden, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
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.
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.
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.
- 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.
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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Randall T. Hayden, MD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
Click here to add this to my saved trials
