Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients (NCT02464098) | Clinical Trial Compass
CompletedNot Applicable
Epidemiology of Diarrheal Diseases in Pediatric Oncology Patients
United States200 participantsStarted 2015-11-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency by pathogen type of infectious pathogens
Timeframe: at 12 months
2
Proportion by pathogen type of infectious pathogens