Extranodal NK/T-cell Lymphoma, Nasal TypePINKNCT02386813
International Extranodal NK/T-cell Lymphoma Project
An observational study of Extranodal NK/T-cell Lymphoma, Nasal Type, run by Samsung Medical Center at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, Nasal Type
- How many people
- 770 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Seoul, 135-710
Samsung Medical Center
Seoul, 135710
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time between the date of diagnosis and any kinds of death
Measured: 5 year
Secondary outcomes (1)
Progression-free survival
Time between the date of diagnosis and any kinds of death or relapse/progression
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T-cell Lymphoma, Nasal TypeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seok Jin Kim, Consortium for Improving Survival of Lymphoma, Asia Lymphoma Study Group, Lymphoma Study Association, 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, Deok-Hwan Yang, Jae-Cheol Jo, Gyeong-Won Lee, Chul Won Choi, Won-Sik Lee, Tsai-Yun Chen, Kiyeun Kim, Sin-Ho Jung, Tohru Murayama, Yasuhiro Oki, Ranjana Advani, Francesco d'Amore, Norbert Schmitz, Cheolwon Suh, Ritsuro Suzuki, Yok Lam Kwong, Tong-Yu Lin
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Won Seog Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386813
- Sponsor's protocol ID
- 2013-03-071
- Acronym
- PINK
- Status last verified
- Apr 2017
- First submitted
- 6 Mar 2015
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Extranodal NK/T-cell Lymphoma Project: Prognostic Factors in the Era of Nonanthracycline-based Treatment
- ClinicalTrials.gov ID
- NCT02386813
- Acronym / sponsor ID
- PINK / 2013-03-071
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Seok Jin Kim, Consortium for Improving Survival of Lymphoma, Asia Lymphoma Study Group, Lymphoma Study Association, 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, Deok-Hwan Yang, Jae-Cheol Jo, Gyeong-Won Lee, Chul Won Choi, Won-Sik Lee, Tsai-Yun Chen, Kiyeun Kim, Sin-Ho Jung, Tohru Murayama, Yasuhiro Oki, Ranjana Advani, Francesco d'Amore, Norbert Schmitz, Cheolwon Suh, Ritsuro Suzuki, Yok Lam Kwong, Tong-Yu Lin
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 5 year
Time between the date of diagnosis and any kinds of death
1 secondary outcome
Progression-free survival
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Seog Kim, MD, PhD principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extranodal NK/T-cell Lymphoma, Nasal Type, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.