Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cohort of Peripheral T Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02364466
Recruitment Status : Recruiting
First Posted : February 18, 2015
Last Update Posted : February 18, 2015
Sponsor:
Collaborators:
Samsung Medical Center
Asan Medical Center
Keimyung University Dongsan Medical Center
Kosin University Gospel Hospital
Dankook University
Soonchunhyang University Hospital
Ajou University School of Medicine
Yeungnam University Hospital
Ulsan University Hospital
Inje University
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Hallym University Medical Center
Hanyang University Seoul Hospital
Seoul National University Hospital
Pusan National University Hospital
National Health Insurance Service Ilsan Hospital
Hanyang University
Information provided by (Responsible Party):
Sujin Kang, Korea Cancer Center Hospital

Brief Summary:
Prospective, observational cohort study of peripheral T cell lymphoma. Purpose is to investigate the complication including febrile neutropenia in the era of pegylated G-CSF prophylaxis.

Condition or disease
Lymphoma, T-Cell, Peripheral Febrile Neutropenia

Detailed Description:
Prospective evaluation of frequencies of febrile neutropenia or infectious complications in a homogeneous population of patients with peripheral T cell lymphoma

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2019 Years
Official Title: Multicenter Prospective Cohort Study of Peripheral T Cell Lymphoma
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019





Primary Outcome Measures :
  1. Febrile neutropenia [ Time Frame: 2 years after the last enrollment ]
    Incidence and severity of febrile neutropenia


Secondary Outcome Measures :
  1. Infectious complication [ Time Frame: 2 years after the last enrollment ]
    incidence, severity, microbiology of infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Peripheral T-cell lymphoma as followings:

Anaplastic large cell lymphoma angioimmunoblastic T cell lymphoma Peripheral T cell lymphoma-NOS Enteropathy-associated T cell lymphoma Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma Primary cutaneous gamma-delta T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotropic lymphoma

Criteria

Inclusion Criteria:

  1. Treatment naive peripheral T cell lymphoma

    Subtypes are as followings:

    Anaplastic large cell lymphoma angioimmunoblastic T cell lymphoma Peripheral T cell lymphoma-NOS Enteropathy-associated T cell lymphoma Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma Primary cutaneous gamma-delta T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotropic lymphoma

  2. Scheduled to receive chemotherapy of curative intent
  3. 19 years old or over
  4. Expected survival is more than 6 months
  5. Informed consent

Exclusion Criteria:

  1. Other histology than those described above

    • Extranodal NK/T cell lymphoma
    • Other than peripheral T cell lymphoma
  2. Other combined malignancy
  3. Previous history of chemotherapy or radiation therapy
  4. No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364466


Contacts
Layout table for location contacts
Contact: Dong-Yeop Shin, M.D. +82-2-970-1246 baramg@hanmail.net

Locations
Layout table for location information
Korea, Republic of
Dankook University Hospital Not yet recruiting
Cheonan, Korea, Republic of
Keimyung University Dongsan Hospital Not yet recruiting
Daegu, Korea, Republic of
Contact: Young Rok Do         
Yeungnam University Hospital Not yet recruiting
Daegu, Korea, Republic of
Hanyang University Guri Hospital Not yet recruiting
Guri, Korea, Republic of
Inje University Ilsan Paik Hospital Not yet recruiting
Ilsan, Korea, Republic of
National Health and Insurance Service Ilsan Hospital Not yet recruiting
Ilsan, Korea, Republic of
Kosin Universithy Gospel Hospital Not yet recruiting
Pusan, Korea, Republic of
Pusan National University Hospital Not yet recruiting
Pusan, Korea, Republic of
Korea Cancer Center Hospital Recruiting
Seoul, Korea, Republic of, 139-706
Contact: Dong-Yeop Shin, M.D.    +82-2970-1246    baramg@hanmail.net   
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Dok Hyun Yoon, M.D.,Ph.D.         
Choong Ang University Hospital Not yet recruiting
Seoul, Korea, Republic of
Hallym University Hospital Not yet recruiting
Seoul, Korea, Republic of
Hanyang University Hospital Not yet recruiting
Seoul, Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Won Seog Kim, M.D., Ph.D.         
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Soonchunhyang University Hospital Not yet recruiting
Seoul, Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Seong Hyun Jeong, M.D.,Ph.D.         
Ulsan University Hospital Not yet recruiting
Ulsan, Korea, Republic of
Sponsors and Collaborators
Korea Cancer Center Hospital
Samsung Medical Center
Asan Medical Center
Keimyung University Dongsan Medical Center
Kosin University Gospel Hospital
Dankook University
Soonchunhyang University Hospital
Ajou University School of Medicine
Yeungnam University Hospital
Ulsan University Hospital
Inje University
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Hallym University Medical Center
Hanyang University Seoul Hospital
Seoul National University Hospital
Pusan National University Hospital
National Health Insurance Service Ilsan Hospital
Hanyang University
Investigators
Layout table for investigator information
Principal Investigator: Won Seog Kim, M.D., Ph.D. Samsung Medical Center

Additional Information:

Layout table for additonal information
Responsible Party: Sujin Kang, CRA, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT02364466     History of Changes
Other Study ID Numbers: Giraffe-T
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neutropenia
Febrile Neutropenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases