RECRUITING

Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis

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: \- Coccidioidomycosis is caused by a fungus that grows in the southwest United States and parts of Mexico and South America. This disease is caused by breathing dust containing the fungus. It can lead to serious lung and breathing problems. Rarely, the fungus can infect other body parts. This is called disseminated coccidioidomycosis (DCM). If the fungus stays in the lungs for more than 6 months, it is called refractory coccidioidomycosis (RCM). People with DCM or RCM may have difficulty fighting off infection because of immune system problems. Researchers want to study the immune systems of people with DCM or RCM, to learn more about the disease and the best ways to treat it. They also want to learn more about the types of people that get DCM or RCM and about the fungus that causes it. Objectives: \- To learn more about DCM and RCM, the fungus that causes these diseases, and the people who get them. Eligibility: \- People over age 2 with DCM or RCM. Design: * Participants will be screened with a review of their medical records. * At the initial visit, participants will have: * Medical history and physical exam * Blood and urine tests. Some blood may be used for genetic testing. The samples will not include participants names. Participants will be notified only if the tests show something urgent about their DCM/RCM. Researchers think this sort of problem will be rare. * Questionnaire about their DCM/RCM * Sputum (mucus) collection. They will spit into a cup. * Participants will have 1 follow-up visit per year. They will have blood tests. They may have other procedures to treat their DCM/RCM.

Official Title

The Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis

Quick Facts

Study Start:2014-09-02
Study Completion:2029-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02190266

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:2 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age greater than or equal to 2 years old.
  2. 2. Have a positive Coccidioides antigen load or culture proven (a) refractory pulmonary coccidioidomycosis or (b) disseminated coccidioidomycosis.
  3. 1. Refractory pulmonary coccidioidomycosis must have occurred for at least 6 months and includes progressive pulmonary involvement without significant pulmonary cavitation.
  4. 2. Disseminated CM is coccidioidomycosis infection in one or more regions outside of the chest.
  5. 3. Agree to undergo genetic testing.
  6. 4. Allow their samples to be stored for future research.
  1. 1. HIV infection
  2. 2. Currently taking more than 20 mg/day of prednisone or undergoing active immunosuppressive therapy in the opinion of the investigator
  3. 3. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent.

Contacts and Locations

Study Contact

Dawn E Shaw, R.N.
CONTACT
(301) 401-4740
dawn.shaw2@nih.gov
Steven M Holland, M.D.
CONTACT
(301) 402-7684
sholland@mail.nih.gov

Principal Investigator

Steven M Holland, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

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

Collaborators and Investigators

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

  • Steven M Holland, M.D., 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 Date2014-09-02
Study Completion Date2029-07-31

Study Record Updates

Study Start Date2014-09-02
Study Completion Date2029-07-31

Terms related to this study

Keywords Provided by Researchers

  • Extrapulmonary
  • Immunodeficiency
  • Genetics
  • Infection
  • Fungal
  • Natural History

Additional Relevant MeSH Terms

  • Coccidioidomycosis