NCT03040206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

January 31, 2017

Last Update Submit

August 5, 2019

Conditions

Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell LymphomaAnaplastic Large Cell Lymphoma, ALK-negative

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

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

    5 year

Secondary Outcomes (1)

  • overall survival

    5 year

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed, pathologically prove nodal PTCL (PTCN-NOS; AITL; ALCL, ALK-negative)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk Nationla University Hospital

Jeonju, 561-712, South Korea

Location

MeSH Terms

Conditions

Lymphoma, T-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, Anaplastic

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathy

Study Officials

  • Ho-Young Yhim

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 2, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)