Characterization of the Microbiome in Cutaneous T Cell Lymphoma

NCT ID: NCT03932279

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-30

Study Completion Date

2028-08-31

Brief Summary

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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

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Conditions

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Cutaneous T Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stage IA-IIA cutaneous T cell lymphoma

No interventions assigned to this group

Stage IIB and above cutaneous T cell lymphoma

No interventions assigned to this group

CD30+ lymphoproliferative disorders

No interventions assigned to this group

Plaque psoriasis with BSA>5% on routine phototherapy

No interventions assigned to this group

Moderate to severe atopic dermatitis on routine bleach bath

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Xiaolong (Alan) Zhou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dermatology CTU

Role: CONTACT

312-503-5944

Facility Contacts

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Dermatology CTU

Role: primary

312-503-5944

Other Identifiers

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XZ05212018

Identifier Type: -

Identifier Source: org_study_id

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