International Extranodal NK/T-cell Lymphoma Project (PINK)

April 8, 2017 updated by: Won Seog Kim, Samsung Medical Center

International Extranodal NK/T-cell Lymphoma Project: Prognostic Factors in the Era of Nonanthracycline-based Treatment

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.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a retrospective cohort study using anonymized information from patients with ENKTL. The following criteria are required: (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. The pathology of initial diagnosis was reviewed by designated pathologists.

Study Type

Observational

Enrollment (Actual)

770

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 135710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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
  • Chemotherapy not including anthracycline such as doxorubicin (e.g. SMILE, VIPD) The type of salvage treatment will not be a criterion for exclusion. Thus, patients who had received various kinds of salvage treatment including anthracycline-containing regimens can be included. Patients who had undergone autologous or allogeneic stem cell transplantation can also be included in the analysis if they satisfy the above-mentioned inclusion criteria.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 year
Time between the date of diagnosis and any kinds of death
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 5 year
Time between the date of diagnosis and any kinds of death or relapse/progression
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Consortium for Improving Survival of Lymphoma
Lymphoma Study Association
Deok-Hwan Yang
Ranjana Advani
Cheolwon Suh
Seok Jin Kim
Asia Lymphoma Study Group
Dok Hyun Yoon
Arnaud Jaccard
Wee Joo Chng
Soon Thye Lim
Huangming Hong
Yong Park
Kian Meng Chang
Yoshinobu Maeda
Fumihiro Ishida
Dong-Yeop Shin
Jin Seok Kim
Seong Hyun Jeong
Jae-Cheol Jo
Gyeong-Won Lee
Chul Won Choi
Won-Sik Lee
Tsai-Yun Chen
Kiyeun Kim
Sin-Ho Jung
Tohru Murayama
Yasuhiro Oki
Francesco d'Amore
Norbert Schmitz
Ritsuro Suzuki
Yok Lam Kwong
Tong-Yu Lin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (ESTIMATE)

March 12, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 8, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-03-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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