RECRUITING

Evaluation of Patients With Gastrointestinal Disease

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

Background: Ongoing and future research projects that study gastrointestinal diseases depend on access to biological samples and clinical data. Researchers want to study people who are seen and treated for these diseases. This may help them assess and treat these diseases better in the future. Objective: To collect data and samples from people being seen and/or treated for gastrointestinal problems at NIH, to use in future research. Eligibility: Adults aged 18 and older who have known or suspected gastrointestinal disorders or need screening, treatment, or follow-up per current medical guidelines. Design: Participants will be screened with a physical exam. Their medical records will be reviewed. Participants will be seen by doctors based on the ailment they have. Their condition will be treated just like it would at a doctor s office. But the data and samples collected will be used for future research. Participants may give blood, urine, and/or stool samples. If participants have an endoscopy or colonoscopy as part of their standard care and samples are taken, they may be asked to give their leftover samples to NIH. Or, they may be asked to have extra samples taken for NIH to use. These samples may include gastric acid and/or tissue from the lining of the stomach or intestines. If samples are not taken as part of their standard care, they may be asked to have samples taken for NIH to use. Data will be stored at NIH. The data systems are password protected. Samples will be coded. Participants will take part in the study for as long as they agree to be seen for their disease....

Official Title

Evaluation of Patients With Gastrointestinal Disease

Quick Facts

Study Start:2022-01-04
Study Completion:2035-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05041374

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:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female, aged \>= 18 years of age
  2. 2. Known or suspected gastrointestinal disorders or requiring clinical screening, management and/or treatment and follow-up per current American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE) or the American Association for the Study of Liver Disease (AASLD).
  1. 1. Significant medical illnesses that the investigators feel may interfere with potential evaluations.
  2. 2. Absence of a referring community physician who would be able to manage care outside of the NIH.
  3. 3. Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient.
  4. 4. Inability to provide informed consent.

Contacts and Locations

Study Contact

Beverly E Niles
CONTACT
(301) 451-0659
beverly.niles@nih.gov
Sheila Kumar, M.D.
CONTACT
(301) 496-9730
sheila.kumar@nih.gov

Principal Investigator

Sheila Kumar, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Sheila Kumar, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 Date2022-01-04
Study Completion Date2035-12-31

Study Record Updates

Study Start Date2022-01-04
Study Completion Date2035-12-31

Terms related to this study

Keywords Provided by Researchers

  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Small Bowel Disease
  • Upper GI Disease
  • Natural History

Additional Relevant MeSH Terms

  • Lower GI Disease
  • Gastrointestinal Diseases