RECRUITING

Natural History and Development of Spondyloarthritis

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: \- Spondyloarthritis (SpA) is a group of bone and joint disorders that may cause back and joint pain and stiffness. In some cases, SpA can lead to abnormal bone growth affecting the joints and spine. Some patients have SpA without ever developing these growths, while others develop them after only a few years. Researchers are interested in studying people with SpA and their relatives to determine which people are more likely to develop more severe conditions. Objectives: \- To identify symptoms and medical tests that can help determine whether a person with SpA is at risk for developing more severe forms of the disease. Eligibility: * Individuals of any age who have been diagnosed with SpA. * Healthy volunteer relatives (at least 6 years of age) of the individuals with SpA. Design: * Participants will be screened with medical records and family medical histories, and will be invited to the clinical center for the study. * Participants with SpA will have a physical exam and medical history, including a study of joint movement, blood and urine tests, and questionnaires about pain and quality of life. * Participants with SpA will have imaging studies, including magnetic resonance imaging (MRI). Other samples such as skin tissue and bone marrow may also be collected for study. * Healthy volunteers will provide a blood sample and cheek cell samples. * No treatment will be provided, although treatment options will be discussed....

Official Title

Studies on the Natural History and Pathogenesis of Spondyloarthritis

Quick Facts

Study Start:2011-08-12
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01422694

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 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients less than 16 years of age will be considered to have SpA if they meet the ILAR criteria for ERA (without or with psoriasis or a positive family history of psoriasis), or modified NY criteria for AS.
  2. 2. Patients 16 years of age or older will be considered to have SpA if they have previously met ILAR criteria for ERA, or currently meet ESSG or Amor criteria for USpA, ASAS criteria for Axial SpA, or modified NY criteria for AS.
  3. 3. Family members of individuals included under items 1 and 2. Family members will not be asked to submit to bone marrow aspiration or interruption of therapy.
  4. 4. Controls for clinical, cellular, molecular, and biochemical assays, and genetic evaluation will be enrolled. Individuals who undergo phlebotomy specifically to provide a control specimen will be 6 years of age or older, and not pregnant.
  5. 5. Minor healthy volunteers undergoing imaging (SI and/or WB MRI) must be old enough to complete the procedure without sedation. Generally this requires that they be at least 6 years of age, so no healthy volunteers under age 6 will be enrolled.
  6. 6. Pregnant people with SpA are allowed to enrolled. Pregnant people will not be asked to undergo an MRI and will not be asked to submit to skin biopsy or bone marrow aspiration.
  1. 1. Inability to provide informed consent or, in the case of minors, unavailability of a parent or guardian.
  2. 2. Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.
  3. 3. Unavailability, or inability to comply with the schedule for follow-up visits.
  4. 4. Children under the age of 2 years old.

Contacts and Locations

Study Contact

April D Brundidge, R.N.
CONTACT
(301) 443-5407
brundidgea@mail.nih.gov
Sahar Lotfi-Emran, M.D.
CONTACT
(301) 443-8935
sahar.lotfi-emran@nih.gov

Principal Investigator

Sahar Lotfi-Emran, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  • Sahar Lotfi-Emran, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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 Date2011-08-12
Study Completion DateN/A

Study Record Updates

Study Start Date2011-08-12
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Sacroiliitis
  • Ankylosing Spondylitis
  • Spondyloarthritis
  • HLA-B27
  • Enthesitis-Related Arthritis
  • Natural History

Additional Relevant MeSH Terms

  • Arthritis
  • Spondylitis, Ankylosing