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Characterization of the Microbiome in Cutaneous T Cell Lymphoma

ConditionCutaneous T Cell Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: Stage IA-IIA cutaneous T cell lymphoma
Group B: Stage IIB and above cutaneous T cell lymphoma
Group C: CD30+ lymphoproliferative disorders
Group D: Plaque psoriasis with BSA>5% on routine phototherapy
Group E: Moderate to severe atopic dermatitis on routine bleach bath
Group F: Healthy controls

Trial outcomes

Primary outcomes

1

Bacterial diversity index

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

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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