Characterization of the Microbiome in Cutaneous T Cell Lymphoma

NCT03932279 | Recruiting

• 1 other identifier: XZ05212018
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Bacterial diversity index

  Diversity analysis of microbiome samples (measured by number of bacteria species/sample)

  3 months

Study Arms (6)

Stage IA-IIA cutaneous T cell lymphoma

Stage IIB and above cutaneous T cell lymphoma

CD30+ lymphoproliferative disorders

Plaque psoriasis with BSA>5% on routine phototherapy

Moderate to severe atopic dermatitis on routine bleach bath

Healthy controls

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cutaneous T cell lymphoma, atopic dermatitis, and psoriasis and healthy individuals without any of these conditions will be enrolled at Northwestern Memorial Hospital Dermatology outpatient clinic.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alan Zhou, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dermatology CTU

CONTACT

312-503-5944; NUderm-research@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: April 30, 2019
• Study Start: January 30, 2019
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2025-04

Locations

US (1)