Characterization of the Microbiome in Cutaneous T Cell Lymphoma

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03932279

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous T Cell Lymphoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Characterization of the Microbiome in Cutaneous T Cell Lymphoma

Actual Study Start Date :

Jan 30, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Bacterial diversity index [3 months]
Diversity analysis of microbiome samples (measured by number of bacteria species/sample)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator: Alan Zhou, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaolong (Alan) Zhou, Principal Investigator, Northwestern University

ClinicalTrials.gov Identifier:

NCT03932279

Other Study ID Numbers:

XZ05212018

First Posted:

Apr 30, 2019

Last Update Posted:

Oct 5, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, T-Cell, Cutaneous

Study Results

No Results Posted as of Oct 5, 2021