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NCT03932279 Clinical Trial

Characterization of the Microbiome in Cutaneous T Cell Lymphoma

Cutaneous T Cell Lymphoma Clinical Trial

Official title:
Characterization of the Microbiome in Cutaneous T Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03932279
Other study ID # XZ05212018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2019
Est. completion date August 31, 2028

Study information
Verified date March 2024
Source Northwestern University
Contact Dermatology CTU
Phone 312-503-5944
Email NUderm-research@northwestern.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigators plan to perform a pilot study that aims to characterize the microbiome of human cutaneous T cell lymphoma patients and compare this to the microbiome of age and sex matched controls.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date August 31, 2028
Est. primary completion date February 28, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - Group 1: Patients with stage IA-IIA cutaneous T cell lymphoma - Group 2: Patients with stage IIB and above cutaneous T cell lymphoma - Group 3: Patients with CD30+ lymphoproliferative disorder including lymphomatoid papulosis and cutaneous anaplastic large cell lymphoma - Group 4: Patients with plaque psoriasis with BSA>5% on routine phototherapy per standard of care - Group 5: Patients with moderate to severe atopic dermatitis on routine bleach bath therapy per standard of care - Group 6: Healthy individuals without the above skin conditions, similar age and sex distribution to the patients with cutaneous T cell lymphoma - All Groups: subjects who are age 18-89 years of age at time of enrollment - All Groups: Subjects who are able and willing to give informed consent for this study and the Dermatology Tissue Acquisition and Biorepository (STU00009443). Exclusion Criteria: - All Groups: Subjects who are younger than 18 years of age or older than 90 years of age - All Groups: Subjects who are unable to give consent - Patients currently on systemic antibiotics or recent (within past 4 weeks) exposure to systemic antibiotics - We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bacterial diversity index Diversity analysis of microbiome samples (measured by number of bacteria species/sample) 3 months
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