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Risk Stratification of Nodal PTCL

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ClinicalTrials.gov Identifier: NCT03040206
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Chonnam National University Hospital
Kyungpook National University
Keimyung University Dongsan Medical Center
Korea University Anam Hospital
Korea University Guro Hospital
Dong-A University Hospital
Pusan National University Hospital
Yeungnam University Hospital
Inje University
Chungnam National University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
Ho-Young Yhim, Chonbuk National University Hospital

Brief Summary:
This study is to investigate the prognostic significance of enhanced International Prognostic Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL patients.

Condition or disease
Peripheral T-Cell Lymphoma, Not Otherwise Specified Angioimmunoblastic T-cell Lymphoma Anaplastic Large Cell Lymphoma, ALK-negative

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Study Type : Observational
Actual Enrollment : 405 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter Study to Assess the Prognostic Significances of NCCN-IPI and Post-treatment PET Results in Patients With Newly Diagnosed Nodal PTCL
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017


Group/Cohort
Nodal PTCL
  1. newly-diagnosed, pathologically-proven nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma [ALCL], anaplastic lymphoma kinase [ALK]-negative) between January 1, 2005 and Jun 30, 2016
  2. initially treated with curative intent
  3. Standard PET or PET-CT data available at the time of diagnosis and at the end of primary treatment



Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 5 year ]
    Time between the date of diagnosis and any kinds of death or disease relapse/progrression


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 year ]
    Time between the date of diagnosis and any kinds of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed, pathologically prove nodal PTCL (PTCN-NOS; AITL; ALCL, ALK-negative)
Criteria

Inclusion Criteria:

  • Patients diagnosed with nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma [ALCL], anaplastic lymphoma kinase [ALK]-negative)
  • Patients diagnosed with between January 1, 2004 and April 30, 2016
  • initially treated with curative intent
  • Patients with standard 18F-fluorodeoxyglucose (FDG) PET or PET-CT data at the time of diagnosis and at the end of primary treatment

Exclusion Criteria:

  • Patients diagnosed with extranodal PTCLs, including followings (extranodal NK/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; EBV-positive T-cell lymphoproliferative childhood disorders, and primary cutaneous lymphomas)
  • Patients with ALCL-ALK+
  • Patients who do not have 18F-FDG PET or PET-CT data either at diagnosis or at the end of treatment available for review

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): NCT03040206


Locations
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Korea, Republic of
Chonbuk Nationla University Hospital
Jeonju, Korea, Republic of, 561-712
Sponsors and Collaborators
Chonbuk National University Hospital
Chonnam National University Hospital
Kyungpook National University
Keimyung University Dongsan Medical Center
Korea University Anam Hospital
Korea University Guro Hospital
Dong-A University Hospital
Pusan National University Hospital
Yeungnam University Hospital
Inje University
Chungnam National University Hospital
Samsung Medical Center
Investigators
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Principal Investigator: Ho-Young Yhim Chonbuk National University Hospital

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Responsible Party: Ho-Young Yhim, Assistant professor, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03040206     History of Changes
Other Study ID Numbers: nodal PTCL
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphadenopathy