Tissue Repository: CTCL Collection Protocol

  • STATUS
    Recruiting
  • days left to enroll
    39
  • participants needed
    400
  • sponsor
    Columbia University
Updated on 14 May 2022
lymphoma
skin disorder
psoriasis
eczema
sezary syndrome
sezary cell count
Accepts healthy volunteers

Summary

This document is a protocol for a non-interventional human research study in which the investigator hopes to better understand the changes that take place in T cells in Cutaneous T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the collection and storage of tissue samples from patients with CTCL for future research studies. Collection and storage of tissue samples from control patients will also be carried out.

Description

CTCL is a heterogeneous group of non-Hodgkin's lymphomas characterized by chronic inflammation and accumulation of malignant T cells in the skin. In order to carry out research to expand the knowledge and develop more effective treatments, tissue samples from CTCL patients with presumed or known disorders are required and tissue samples from control patients will be required to compare the differences between affected and healthy populations.

Scientists will be able to test new ideas and new technologies that are not apparent or available at the present moment from this tissue repository in the future. This type of information will thus be of great advantage to future patients with these diseases.

Details
Condition Lymphoma, T-Cell, Cutaneous, Lymphomatoid Papulosis, Sézary Syndrome
Clinical Study IdentifierNCT02840747
SponsorColumbia University
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with CTCL or Lymphomatoid Papulosis (LYP): a clinical or histologic diagnosis of a) newly diagnosed, b) progressive, or c) relapsed CTCL or LYP who are initiating or changing therapy
Patients with Sézary Syndrome (SS) or stage IV B CTCL as defined by blood involvement on flow cytometry or morphology: (1) ≥1000/μL Sézary cells by morphology; (2) Cluster of differentiation 4 (CD4)/cluster of differentiation 8 (CD8) ratio ≥10; (3) CD4+cluster of differentiation 7 (CD7)- cells ≥40 percent; (4) or CD4+cluster of differentiation 26 (CD26)- cells ≥30 percent
Ability to understand and willing to sign a willing informed consent document
Age ≥ 18 years
Inclusion Criteria for Age and Sex Matched Controls
Matched for sex, and age +/- 10 years
Ability to sign informed consent document
Patients with or without benign inflammatory skin conditions including, but not limited to, eczema, psoriasis, or dermatitis or Patients without skin conditions requiring treatment with systemic immunosuppressive, biologic, or chemotherapeutic agents

Exclusion Criteria

Patients with a history of previous lymphoma other than CTCL or SS or LYP
Medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator
Current, viable pregnancy
Anemia with a documented hemoglobin laboratory value of <7.5 g/dl within the past 6 months
Exclusion Criteria for Age and Sex Matched Controls
Previous history of CTCL, SS, LYP, or any lymphoma
Previous history of Human Immunodeficiency Virus (HIV) infection
Anemia with a documented hemoglobin laboratory value of <7.5 g/dl within the past 6 months
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note