ACTIVE_NOT_RECRUITING

Longitudinal Spatial Frequency Domain Imaging Study

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

Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently imprecise and subjective methods that varies amongst different doctors for the same patient are available to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS). Skin thickness and the amount of fibrosis can change over time due to disease progression or in response to therapy. In this research, longitudinal measurements will be taken to determine if spatial frequency domain imaging (SFDI) can detect changes in skin thickness that occur over time in response to therapy or from disease progression in scleroderma patients. This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness). SFDI information will also be compared with capillaroscopy (allows for non-invasive imaging of the nailfold capillaries) if available from the electronic medical record. If SFDI correlates well with other clinical outcome assessments, it may be used in the future as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients.

Official Title

Spatial Frequency Domain Imaging, Comparison of a Novel Method to Quantify Skin Fibrosis With Currently Used Methods in Scleroderma

Quick Facts

Study Start:2023-02-10
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05672992

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have SSc as defined by the American College of Rheumatology (SSc subjects only)
  2. * Suspected of having SSc based on clinical symptoms as determined by their physician (SSc subjects only)
  3. * Defined as a healthy control (does not have SSc or another known disease that in the opinion of the investigator could confound the results)
  1. * Diagnosis of skin malignancy within the previous 2 years, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ.
  2. * Presence of wounds or skin rashes at the site of Spatial frequency domain imaging (SFDI) measurement or skin biopsy
  3. * Presence of other co-morbid illnesses with an estimated median life expectancy \< 5 years.

Contacts and Locations

Principal Investigator

Andreea Bujor, MD, PhD
PRINCIPAL_INVESTIGATOR
BU Chobanian & Advesian School of Medicine

Study Locations (Sites)

Shapiro Outpatient Rheumatology Clinic at Boston Medical Center
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston University

  • Andreea Bujor, MD, PhD, PRINCIPAL_INVESTIGATOR, BU Chobanian & Advesian School of Medicine

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 Date2023-02-10
Study Completion Date2028-09

Study Record Updates

Study Start Date2023-02-10
Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

  • Spatial frequency domain imaging (SFDI)
  • modified Rodnan skin score (mRSS)
  • Skin biopsy
  • Skin fibrosis
  • Scleroderma skin patient reported outcome (SSPRO)
  • Durometry
  • Ultrasound

Additional Relevant MeSH Terms

  • Systemic Scleroderma