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出境医 / 临床实验 / Characterization of the Microbiome in Cutaneous T Cell Lymphoma
Characterization of the Microbiome in Cutaneous T Cell Lymphoma
Study Description
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.
| Condition or disease |
|---|
| Cutaneous T Cell Lymphoma |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Characterization of the Microbiome in Cutaneous T Cell Lymphoma |
| Actual Study Start Date : | January 30, 2019 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
Arms and Interventions
| Group/Cohort |
|---|
| 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 |
Outcome Measures
Primary Outcome Measures :
- Bacterial diversity index [ Time Frame: 3 months ]Diversity analysis of microbiome samples (measured by number of bacteria species/sample)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations
Contacts
| Contact: Dermatology CTU | 312-503-5944 | NUdermatologyCTU@northwestern.edu |
Locations
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Dermatology CTU 312-503-5944 NUdermatologyCTU@northwestern.edu | |
| Principal Investigator: Alan Zhou, MD | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Alan Zhou, MD | Northwestern University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | February 18, 2019 | ||||
| First Posted Date | April 30, 2019 | ||||
| Last Update Posted Date | August 4, 2020 | ||||
| Actual Study Start Date | January 30, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Bacterial diversity index [ Time Frame: 3 months ] Diversity analysis of microbiome samples (measured by number of bacteria species/sample)
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Characterization of the Microbiome in Cutaneous T Cell Lymphoma | ||||
| Official Title | Characterization of the Microbiome in Cutaneous T Cell Lymphoma | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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. | ||||
| Condition | Cutaneous T Cell Lymphoma | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
300 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2020 | ||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 89 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
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| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03932279 | ||||
| Other Study ID Numbers | XZ05212018 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Xiaolong (Alan) Zhou, Northwestern University | ||||
| Study Sponsor | Northwestern University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Northwestern University | ||||
| Verification Date | August 2020 | ||||
