RECRUITING

CHIP/CCUS Natural History 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: Clonal Hematopoiesis of Indeterminate Potential (CHIP) is a change in a person s DNA that can increase a person s risk of developing blood cancers or cardiovascular disease. CHIP occurs mostly occurs in older people. Clonal cytopenia of undetermined significance (CCUS) occurs when one or more blood cell types is lower than it should be and is associated with a change in their DNA. Researchers want to learn more about how CHIP and CCUS progress. Objective: To examine the natural history of people in a study of CHIP and CCUS to (1) verify the association of myeloid somatic mutations with atherosclerosis and blood cancers, and (2) find new potential clinical associations. Eligibility: Adults 18 and older with CHIP with a somatic pathogenic variant associated with blood cancers. Adults with CCUS are also needed. Design: Potential participants will be screened with gene testing. For this, they will give a blood sample. They will also be enrolled in NHLBI screening protocol #97-H-0041. Those who pass this screening will visit the NIH Clinical Center for more screening tests. For this, they will give a blood sample. They will have a physical exam. They will give their medical history. They may give a urine sample. Those with CCUS will have bone marrow taken. Eligible participants will give blood and urine samples. Their heart activity will be monitored and tested. The arteries in their neck will be assessed using ultrasound. They will have liver and heart scans. They will have a bone mineral density scan. They will have lung function tests. They will have the inside of their cheek swabbed or have a skin punch biopsy. They will have the option to have advanced scans done of their heart and full body but this is not required. Participants will have yearly follow-up visits for 10 years. They will repeat the above procedures every 1-3 years depending on the procedure.

Official Title

Investigation of the Natural Progression of Clonal Hematopoiesis of Indeterminate Potential and Clonal Cytopenia of Undetermined Significance.

Quick Facts

Study Start:2020-03-03
Study Completion:2033-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04102423

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 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Greater than or equal to 18 years of age
  2. * Willingness and capacity to provide written informed consent
  3. * Presence of a somatic pathogenic variant associated with hematological malignancy
  4. * Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant
  1. * Known diagnosis of a hematological malignancy or bone marrow failure syndrome (excluding MGUS or MBL)
  2. * Presence of a cytopenia:
  3. * Pregnant at the time of recruitment
  4. * Treatment with previous chemotherapy or radiotherapy

Contacts and Locations

Study Contact

Tania R Machado
CONTACT
(301) 661-1505
tania.machado@nih.gov
Emma M Groarke, M.D.
CONTACT
(301) 496-5093
emma.groarke@nih.gov

Principal Investigator

Emma M Groarke, M.D.
PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

  • Emma M Groarke, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

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 Date2020-03-03
Study Completion Date2033-09-15

Study Record Updates

Study Start Date2020-03-03
Study Completion Date2033-09-15

Terms related to this study

Keywords Provided by Researchers

  • Cytopenia
  • Myelodysplastic Syndrome
  • Somatic Mutations
  • Natural History

Additional Relevant MeSH Terms

  • Clonal Hematopoiesis of Indeterminate Potential
  • Clonal Cytopenia of Undetermined Significance