RECRUITING

NIAID Centralized Sequencing Protocol

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: Genetic testing called "sequencing" helps researchers look at DNA. Genes are made of DNA and are the instructions for our bodies to function. We all have thousands of genes. DNA variants are differences in genes between two people. We all have lots of variants. Most are harmless and some cause differences like blue or brown eyes. A few variants can cause health problems. Objective: To understand the genetics of immune disorders various health conditions, as well as outcomes of clinical genomics and genetic counseling services performed under this protocol. Eligibility: Participants in other NIH human subjects research protocols - either at the NIH Clinical Center (CC) or at Children s National Health System (CNHS) - (aged 0-99 years), and, in select cases, their biological relatives Design: Researchers will study participant s DNA extracted from blood, saliva, or another tissue sample, including previously collected samples we may have stored at the NIH. Researchers will look at participant s DNA in great detail. We are looking for differences in the DNA sequence or structure between participants and other people. Participants will receive results that: * Are important to their health * Have been confirmed in a clinical lab * Suggest that they could be at risk for serious disease that may affect your current or future medical management. Some genetic information we return to participants may be of uncertain importance. If genetic test results are unrelated to the participant s NIH evaluations, then we will not typically report: * Normal variants * Information about progressive, fatal conditions that have no effective treatment * Carrier status (conditions you don t have but could pass on) The samples and data will be saved for future research. Personal data will be kept as private as possible. If future studies need new information, participants may be contacted.

Official Title

NIAID Centralized Sequencing Protocol

Quick Facts

Study Start:2017-07-31
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03206099

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:1 Day to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must fulfill one of the following criteria:
  2. * Proband participants: must be individuals under investigation by another NIH protocol on which they are co-enrolled, or are referred from the GDMCC protocol "Defining the Genetic Etiology of Suppurative Lung Disease in Children and Adults" (NCT04702243). Probands may have a disease under investigation or be healthy volunteers
  3. * Biological relatives: biologically related to a proband participant.
  4. * Aged 0-99 years.
  5. * Participants must be willing to undergo genetic testing.
  6. * Participants must be willing to allow samples to be stored for future research.
  7. * Participants must be willing to have their de-identified genomic data shared, for example in a controlled access databases like the Database of Genotypes and Phenotypes (dbGaP).
  8. * To complete surveys and interviews:
  9. * Proficient with the English language.
  10. * Able to provide informed consent.
  11. * Adult healthy volunteers must be able to provide informed consent.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Morgan N Similuk
CONTACT
(301) 435-6691
morgan.similuk@nih.gov

Principal Investigator

Morgan N Similuk
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

Children's National Health System
Washington D.C., District of Columbia, 20010
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Morgan N Similuk, PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

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 Date2017-07-31
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2017-07-31
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

  • Phenotyping
  • Genetics
  • Sequencing
  • Inborn Errors of Immunity
  • Genomics
  • Natural History

Additional Relevant MeSH Terms

  • Atopy
  • Primary Immunodeficiency
  • Autoimmunity
  • Autoinflammation