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STAT3 in T Cells: At The Crossroads of Inflammation and Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Amy Sun, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01663571
First received: August 9, 2012
Last updated: July 7, 2014
Last verified: July 2014

August 9, 2012
July 7, 2014
May 2012
April 2015   (final data collection date for primary outcome measure)
Measure the levels of Th 17 cytokines namely Il-17 and Il-22 in CTCL [ Time Frame: 2 -3 years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01663571 on ClinicalTrials.gov Archive Site
Identify STAT3 mutations in CTCL [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
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STAT3 in T Cells: At The Crossroads of Inflammation and Cancer
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 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 treatment with either of these HDAC inhibitors. Two more skin biopsies and/or blood draws will be performed after first and second cycle of treatment.

Levels of Th17 cytokines, IL-17, IL -22 and pSTAT3 protein will be determined by IHC staining in the skin and cytokine levels in the blood will be assayed by sandwich ELISA method.The investigators will also assay the mRNA levels of the transcription factors of the different T effector cells by qPCR.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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. The investigators will assay the mRNA levels of the transcription factors of the different T effector cells by qPCR.

Non-Probability Sample

Patients with Cutaneous T cell Lymphoma (CTCL), either newly diagnosed or with progression of disease. Patients with Eczema, psoriasis and dermatitis are also eligible for the study

Cutaneous T Cell Lymphoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with CTCL that are starting new form of treatment and adult patients with benign dermatoses.

Exclusion Criteria:

  • patients with lymphomas other than CTCL or leukemia
Both
18 Years and older
No
Contact: Amy L Sun, BS 2122637663 amy.sun@nyumc.org
Contact: Sergei B Koralov, PhD 2122637663 sergei.koralov@nyumc.org
United States
 
NCT01663571
11-01293
Not Provided
Amy Sun, New York University School of Medicine
New York University School of Medicine
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Principal Investigator: Sergei Koralov, PhD NYU School of Medicine
New York University School of Medicine
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP