RECRUITING

GpCRC Pediatric Gastroparesis Registry 2

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Conditions

GastroparesisGastroparesis-like SyndromeFunctional Disorder of Gastrointestinal TractGastro-Intestinal Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of the Pediatric Gastroparesis Registry 2 is to create a national prospective registry of children, adolescents, and young adults with gastroparesis and gastroparesis-like syndrome (symptoms of gastroparesis but normal gastric emptying).

Official Title

GpCRC Pediatric Gastroparesis Registry 2: Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric, Adolescent, and Young Adult Participants With Symptoms of Gastroparesis

Quick Facts

Study Start:2024-12-15
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05981300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form and assent, as age appropriate.
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * 8 to 25 years of age at the time of enrollment
  4. * Symptoms of Gp of at least 12 weeks duration: constellation of some combination of:
  5. * Have undergone a gastric emptying scintigraphic study of solids using 4-hour Egg Beaters protocol (or equivalent generic liquid egg white meal) within the last 12 months who fall into one of the two categories:
  6. * Delayed gastric emptying-defined as an abnormal 2-hour (\>60% retention) and/or 4- hour (\>10% retention) result based on a 4-hour scintigraphic gastric emptying study
  7. * Gastric emptying that is not delayed but who have symptoms of Gp (designated in this study as GLS) or have previously participated in the Pediatric Gastroparesis Registry (PGpR) study
  8. * An etiology of either diabetic or idiopathic Gp or GLS
  1. * Inability to comply with or complete the scintigraphic gastric emptying test (including allergy to eggs)
  2. * Pregnancy
  3. * Autism spectrum disorder, significant developmental delay, psychosis (because of inability to complete questionnaires)
  4. * Use of narcotic analgesics greater than three days per week.
  5. * Presence of conditions associated with GI mucosal disease (e.g., inflammatory bowel disease, known eosinophilic gastroenteritis or eosinophilic esophagitis, gastric ulcer, peptic ulcer, celiac disease)
  6. * Presence of any other condition that could case delayed gastric emptying
  7. * Gastrointestinal construction confirmed by upper endoscopy (EGD), upper gastrointestinal series (UGI), or abdominal CT
  8. * Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious legions
  9. * Acute or chronic renal failure (abnormal creatinine for age) and /or on hemodialysis or peritoneal dialysis
  10. * Acute liver failure
  11. * Advanced liver disease (features of portal hypertension)
  12. * Clinically significant congenital heart disease (i.e., vaginal injury during cardiac repair)
  13. * History of esophageal, gastric or bowel surgery.
  14. * Metabolic disease including mitochondrial disease and inborn errors of metabolism
  15. * Chronic lung disease (including cystic fibrosis)
  16. * A serious chronic medical condition (e.g., inflammatory bowel disease)
  17. * Use of medications that can affect motility during the gastric emptying study
  18. * Any other condition, which in the option of the investigator, could explain the symptoms or could interfere with study requirements.

Contacts and Locations

Study Contact

Laura Miriel
CONTACT
410-955-4165
laura.miriel@jhu.edu
Peggy Adamo
CONTACT
410-502-9137
madamo1@jhu.edu

Principal Investigator

Robert J Shulman, MD
STUDY_CHAIR
Baylor College of Medicine
David Shade, JD
PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Texas Tech University Health Science Center
El Paso, Texas, 79905
United States
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Johns Hopkins Bloomberg School of Public Health

  • Robert J Shulman, MD, STUDY_CHAIR, Baylor College of Medicine
  • David Shade, JD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-15
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-12-15
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Functional Disorder of Gastrointestinal Tract
  • Gastro-Intestinal Disorder

Additional Relevant MeSH Terms

  • Gastroparesis
  • Gastroparesis-like Syndrome