Characterization of the Microbiome in Cutaneous T Cell Lymphoma

Recruiting

• Conditions: Cutaneous T Cell Lymphoma

• Registration Number: NCT03932279
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-30
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-04-28
• Study First Posted: 2019-04-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2028-02-28
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacterial diversity index	3 months	Diversity analysis of microbiome samples (measured by number of bacteria species/sample)

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States