NCT02386813

Brief Summary

This study is to explore risk factors for poor progression-free survival (PFS) and overall survival (OS) in ENKTL, and establish a prognostic model for ENKTL patients treated with non-anthracycline based treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
770

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

March 6, 2015

Last Update Submit

April 8, 2017

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Time between the date of diagnosis and any kinds of death

    5 year

Secondary Outcomes (1)

  • Progression-free survival

    5 year

Study Arms (2)

Training cohort

1. Patients diagnosed with ENKTL, nasal type between January 1, 1995 and December 31, 2013; 2. Patients treated with non-anthracycline based therapy as an initial treatment.

Validation cohort

1. Patients diagnosed with ENKTL, nasal type between January 1, 1998 and December 31, 2014; 2. Patients treated with non-anthracycline based therapy as an initial treatment.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1. Patients diagnosed with ENKTL, nasal type between January 1, 1995 and December 31, 2014; 2. Patients treated with non-anthracycline based therapy as an initial treatment.

You may qualify if:

  • Patients diagnosed with ENKTL, nasal type
  • Patients diagnosed between January 1, 1995 and December 31, 2014
  • Patients treated with nonanthracycline-based therapy as the initial treatment after diagnosis
  • Nonanthracycline-based therapy includes the following treatments:
  • Radiotherapy including concurrent chemoradiation

You may not qualify if:

  • Patients who had received anthracycline-based therapy, such as CHOP or CHOP-like regimens, as the initial treatment.
  • Patients who do not have pathology slides available for central review.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Samsung Medical Center

Seoul, 135710, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Won Seog Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 12, 2015

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

KR(2)