## Protocol Section
### Identification Module
**NCT ID:** NCT03932279

**Brief Title:** Characterization of the Microbiome in Cutaneous T Cell Lymphoma

**Official Title:** Characterization of the Microbiome in Cutaneous T Cell Lymphoma

#### Organization Study ID Info
**ID:** XZ05212018
#### Organization
**Class:** OTHER
**Full Name:** Northwestern University
### Status Module
#### Completion Date
**Date:** 2028-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-12

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-02-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-01-30

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2019-04-30
**Type:** ACTUAL
**Study First Submit Date:** 2019-02-18
**Study First Submit QC Date:** 2019-04-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Northwestern University

#### Responsible Party

**Investigator Affiliation:** Northwestern University

**Investigator Full Name:** Xiaolong (Alan) Zhou

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Cutaneous T Cell Lymphoma

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** Stage IA-IIA cutaneous T cell lymphoma

#### Arm Group 2

**Label:** Stage IIB and above cutaneous T cell lymphoma

#### Arm Group 3

**Label:** CD30+ lymphoproliferative disorders

#### Arm Group 4

**Label:** Plaque psoriasis with BSA>5% on routine phototherapy

#### Arm Group 5

**Label:** Moderate to severe atopic dermatitis on routine bleach bath

#### Arm Group 6

**Label:** Healthy controls

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Bacterial diversity index

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 89 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** NUderm-research@northwestern.edu

**Name:** Dermatology CTU

**Phone:** 312-503-5944

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** NUderm-research@northwestern.edu

- **Name:** Dermatology CTU

- **Phone:** 312-503-5944

- **Role:** CONTACT

***Contact 2:***

- **Name:** Alan Zhou, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Northwestern University

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60611

#### Overall Officials

**Official 1:**

**Affiliation:** Northwestern University

**Name:** Alan Zhou, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M18829

- Name: Lymphoma, T-Cell

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: M18833

- Name: Lymphoma, T-Cell, Peripheral

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: M18832

- Name: Lymphoma, T-Cell, Cutaneous

- Relevance: HIGH

- As Found: Cutaneous T-Cell Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T4496

- Name: Peripheral T-cell Lymphoma

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: T1689

- Name: Cutaneous T-cell Lymphoma

- Relevance: HIGH

- As Found: Cutaneous T-Cell Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000016399

- Term: Lymphoma, T-Cell

- ID: D000016411

- Term: Lymphoma, T-Cell, Peripheral

- ID: D000016410

- Term: Lymphoma, T-Cell, Cutaneous

### Misc Info Module

- Version Holder: 2024-05-24
