International Extranodal NK/T-cell Lymphoma Project

NCT ID: NCT02386813

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

770 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Extranodal NK/T-cell Lymphoma, Nasal Type

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seok Jin Kim

UNKNOWN

Sponsor Role collaborator

Consortium for Improving Survival of Lymphoma

OTHER

Sponsor Role collaborator

Asia Lymphoma Study Group

UNKNOWN

Sponsor Role collaborator

Lymphoma Study Association

OTHER

Sponsor Role collaborator

Dok Hyun Yoon

UNKNOWN

Sponsor Role collaborator

Arnaud Jaccard

UNKNOWN

Sponsor Role collaborator

Wee Joo Chng

UNKNOWN

Sponsor Role collaborator

Soon Thye Lim

UNKNOWN

Sponsor Role collaborator

Huangming Hong

UNKNOWN

Sponsor Role collaborator

Yong Park

UNKNOWN

Sponsor Role collaborator

Kian Meng Chang

UNKNOWN

Sponsor Role collaborator

Yoshinobu Maeda

UNKNOWN

Sponsor Role collaborator

Fumihiro Ishida

UNKNOWN

Sponsor Role collaborator

Dong-Yeop Shin

UNKNOWN

Sponsor Role collaborator

Jin Seok Kim

UNKNOWN

Sponsor Role collaborator

Seong Hyun Jeong

UNKNOWN

Sponsor Role collaborator

Deok-Hwan Yang

UNKNOWN

Sponsor Role collaborator

Jae-Cheol Jo

UNKNOWN

Sponsor Role collaborator

Gyeong-Won Lee

UNKNOWN

Sponsor Role collaborator

Chul Won Choi

UNKNOWN

Sponsor Role collaborator

Won-Sik Lee

UNKNOWN

Sponsor Role collaborator

Tsai-Yun Chen

UNKNOWN

Sponsor Role collaborator

Kiyeun Kim

UNKNOWN

Sponsor Role collaborator

Sin-Ho Jung

UNKNOWN

Sponsor Role collaborator

Tohru Murayama

UNKNOWN

Sponsor Role collaborator

Yasuhiro Oki

UNKNOWN

Sponsor Role collaborator

Ranjana Advani

UNKNOWN

Sponsor Role collaborator

Francesco d'Amore

UNKNOWN

Sponsor Role collaborator

Norbert Schmitz

UNKNOWN

Sponsor Role collaborator

Cheolwon Suh

UNKNOWN

Sponsor Role collaborator

Ritsuro Suzuki

UNKNOWN

Sponsor Role collaborator

Yok Lam Kwong

UNKNOWN

Sponsor Role collaborator

Tong-Yu Lin

UNKNOWN

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Won Seog Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Seog Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2013-03-071

Identifier Type: -

Identifier Source: org_study_id

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