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NCT01663571 · ClinicalTrials.gov registry record
STAT3 in T Cells: At The Crossroads of Inflammation and Cancer
A clinical trial, sponsored by NYU Langone Health.
- Terminated
- Registry status
- 35
- Enrollment target
NCT01663571 is a clinical trial that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 35 participants.
The verdict
NCT01663571 was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- 35 participants
- Enrollment target
Study Summary
Protocol Summary Constitutive STAT3 activity is implicated in many malignancies including Cutaneous T Cell Lymphoma. It is also essential for Th17 differentiation, a subset of CD4 effector T cell, implicated in chronic inflammatory conditions and possibly CTCL. HDAC inhibitors have shown activity in CTCL but their exact mechanism of action is not known. It is known that HDAC inhibitors regulate STAT3 transcriptional activity and hence can potentially be active in CTCL through modulation of the STAT3 pathway. The hypothesis is that Th17 cytokines contribute to the initiation of cancer by creating a pro-inflammatory microenvironment that predisposes cells to neoplastic transformation. To probe this, the investigators will compare the differences in cytokine production and gene expression in the skin resident T cells from patients with benign dermatoses and CTCL as well as in the blood/circulating lymphocytes of healthy donors and Sezary syndrome (SS). The investigators will also investigate whether HDAC inhibitors have a direct impact on the number of Th17 cells, the cytokine production by these cells and phosphorylated STAT3 protein in CTCL with subsequent treatment cycles. The objectives of this study are 1. Observe the epigenetic, transcriptional and phenotypic changes that take place in T cell during malignant transformation 2. Understand the mechanism of action of HDAC inhibitors in CTCL. Methods: Skin biopsy specimens from cutaneous T cell lymphoma (CTCL) patients and benign skin conditions namely eczema, dermatitis and psoriasis will be obtained through a standard punch biopsy procedure from the skin lesion. Additionally, 15 ml of peripheral blood from CTCL patients who have Sezary syndrome (SS) and from patients with benign skin condition will be collected. CTCL patients, who are starting treatment with HDAC Inhibitors namely Vorinostat and Romidepsin, will have a total of 3 skin biopsies and/or blood draws. The first procedure would be before starting tr
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2012-05-01 |
| Est. Completion | 2016-11-21 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01663571
The ClinicalTrials.gov registry entry for NCT01663571 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01663571 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01663571 about?
NCT01663571 is a clinical study titled "STAT3 in T Cells: At The Crossroads of Inflammation and Cancer". Protocol Summary Constitutive STAT3 activity is implicated in many malignancies including Cutaneous T Cell Lymphoma. It is also essential for Th17 differentiation, a subset of CD4 effector T cell, implicated in chronic inflammatory conditions and possibly CTCL. HDAC inhibitors have shown activity i...
What is the current status of trial NCT01663571?
This trial is currently terminated. The enrollment target is 35 participants. The study started on 2012-05-01. Estimated completion is 2016-11-21.
Who is sponsoring clinical trial NCT01663571?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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