Cutaneous T Cell LymphomaNCT03932279
Characterization of the Microbiome in Cutaneous T Cell Lymphoma
An observational study of Cutaneous T Cell Lymphoma, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous T Cell Lymphoma
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2019to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Dermatology CTU, 312-503-5944, NUderm-research@northwestern.edu
Alan Zhou, MD
About this study
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
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stage IA-IIA cutaneous T cell lymphoma | Not described | |
| Stage IIB and above cutaneous T cell lymphoma | Not described | |
| CD30+ lymphoproliferative disorders | Not described | |
| Plaque psoriasis with BSA>5% on routine phototherapy | Not described | |
| Moderate to severe atopic dermatitis on routine bleach bath | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial diversity index
Diversity analysis of microbiome samples (measured by number of bacteria species/sample)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start30 Jan 2019
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolong (Alan) Zhou, Northwestern University
- Investigators
- Alan Zhou, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932279
- Sponsor's protocol ID
- XZ05212018
- Status last verified
- Apr 2025
- First submitted
- 18 Feb 2019
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Microbiome in Cutaneous T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03932279
- Acronym / sponsor ID
- XZ05212018
- Conditions
- Cutaneous T Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial diversity index
Time frame: 3 months
Diversity analysis of microbiome samples (measured by number of bacteria species/sample)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Zhou, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous T Cell Lymphoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dermatology CTU (312-503-5944, NUderm-research@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial diversity index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.