Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedNCT03040206
Risk Stratification of Nodal PTCL
An observational study of Peripheral T-Cell Lymphoma, Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-negative
- How many people
- 405 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Dec 2017
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Newly diagnosed, pathologically prove nodal PTCL (PTCN-NOS; AITL; ALCL, ALK-negative)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Study to Assess the Prognostic Significances of NCCN-IPI and Post-treatment PET Results in Patients With Newly Diagnosed Nodal PTCL
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.
- Conditions
- Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-negative
- Medical subject headings
- Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Time between the date of diagnosis and any kinds of death or disease relapse/progrression
Measured: 5 year
Secondary outcomes (1)
overall survival
Time between the date of diagnosis and any kinds of death
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 posted2 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedStudies of the same condition, open and under way.
- 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
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chonnam National University Hospital, Kyungpook National University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Korea University Guro Hospital, Dong-A University Hospital, Pusan National University Hospital, Yeungnam University Hospital, Inje University, Chungnam National University Hospital, Samsung Medical Center
- Responsible party
- Principal investigator, Ho-Young Yhim, Chonbuk National University Hospital
- Investigators
- Ho-Young Yhim, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040206
- Sponsor's protocol ID
- nodal PTCL
- Status last verified
- Aug 2019
- First submitted
- 31 Jan 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study to Assess the Prognostic Significances of NCCN-IPI and Post-treatment PET Results in Patients With Newly Diagnosed Nodal PTCL
- ClinicalTrials.gov ID
- NCT03040206
- Acronym / sponsor ID
- nodal PTCL
- Conditions
- Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-negative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- Chonnam National University Hospital, Kyungpook National University Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Korea University Guro Hospital, Dong-A University Hospital, Pusan National University Hospital, Yeungnam University Hospital, Inje University, Chungnam National University Hospital, Samsung Medical Center
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Feb 2017 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed, pathologically prove nodal PTCL (PTCN-NOS; AITL; ALCL, ALK-negative)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
progression-free survival
Time frame: 5 year
Time between the date of diagnosis and any kinds of death or disease relapse/progrression
1 secondary outcome
overall 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 7 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Ho-Young Yhim principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral T-Cell Lymphoma, Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma, run by Chonbuk National University Hospital at 1 site 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 4 inclusion and 3 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
progression-free 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 7 Aug 2019.