Recruiting

Observational Study

Sponsor:

Northwestern University

Code:

NCT03932279

Conditions

Cutaneous T Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT03932279

Start date

Jan 30, 2019

Status verified date

Apr, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Bacterial diversity index [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Dermatology CTU

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

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Dermatology CTU

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

Principal Investigator:

Alan Zhou, MD

More Information

Sponsor

Northwestern University

Last update posted

May 1, 2026

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-01.