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Characterization of the Microbiome in Cutaneous T Cell Lymphoma

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Northwestern University

Status

Enrolling

Conditions

Cutaneous T Cell Lymphoma

Study type

Observational

Funder types

Other

Identifiers

NCT03932279
XZ05212018

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

300 participants in 6 patient groups

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

Trial contacts and locations

1

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Central trial contact

Dermatology CTU

Data sourced from clinicaltrials.gov

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