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Completed

NCT Number: NCT03040206

Risk Stratification of Nodal PTCL

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.

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Key information

Conditions

Peripheral T-Cell Lymphoma, Not Otherwise Specified Anaplastic Large Cell Lymphoma, ALK-negative Angioimmunoblastic T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonbuk Nationla University Hospital

Jeonju, 561-712, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. progression-free survival

    Time frame: 5 year

    Time between the date of diagnosis and any kinds of death or disease relapse/progrression

Secondary outcomes

  1. overall survival

    Time frame: 5 year

    Time between the date of diagnosis and any kinds of death

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Collaborators

  • Chonnam National University Hospital
  • Chungnam National University Hospital
  • Dong-A University Hospital
  • Inje University
  • Keimyung University Dongsan Medical Center
  • Korea University Anam Hospital
  • Korea University Guro Hospital
  • Kyungpook National University Hospital
  • Pusan National University Hospital
  • Samsung Medical Center
  • Yeungnam University Hospital

Registry information

Official study title

Multicenter Study to Assess the Prognostic Significances of NCCN-IPI and Post-treatment PET Results in Patients With Newly Diagnosed Nodal PTCL

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2017
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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