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Risk Stratification of Nodal PTCL

Sponsor
Chonbuk National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03040206
Collaborator
Chonnam National University Hospital (Other), Kyungpook National University Hospital (Other), Keimyung University Dongsan Medical Center (Other), Korea University Anam Hospital (Other), Korea University Guro Hospital (Other), Dong-A University Hospital (Other), Pusan National University Hospital (Other), Yeungnam University Hospital (Other), Inje University (Other), Chungnam National University Hospital (Other), Samsung Medical Center (Other)
405
Enrollment
1
Location
11
Actual Duration (Months)
36.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 1, 2017
    Actual Primary Completion Date :
    Jun 1, 2017
    Actual Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Nodal PTCL

    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 initially treated with curative intent Standard PET or PET-CT data available at the time of diagnosis and at the end of primary treatment

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [5 year]

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

    Secondary Outcome Measures

    1. overall survival [5 year]

      Time between the date of diagnosis and any kinds of death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonbuk Nationla University Hospital Jeonju Korea, Republic of 561-712

    Sponsors and Collaborators

    • Chonbuk National University Hospital
    • Chonnam National University Hospital
    • Kyungpook National University Hospital
    • 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

    • Principal Investigator: Ho-Young Yhim, Chonbuk National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ho-Young Yhim, Assistant professor, Chonbuk National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03040206
    Other Study ID Numbers:
    • nodal PTCL
    First Posted:
    Feb 2, 2017
    Last Update Posted:
    Aug 7, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral
    Lymphoma, Large-Cell, Anaplastic
    Immunoblastic Lymphadenopathy

    Study Results

    No Results Posted as of Aug 7, 2019