- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040206
Risk Stratification of Nodal PTCL
August 5, 2019 updated by: Ho-Young Yhim, Chonbuk National University Hospital
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
405
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
-
-
-
Jeonju, Korea, Republic of, 561-712
- Chonbuk Nationla University Hospital
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Newly diagnosed, pathologically prove nodal PTCL (PTCN-NOS; AITL; ALCL, ALK-negative)
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Nodal PTCL
|
What is the study measuring?
Primary 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 disease relapse/progrression
|
5 year
|
Secondary 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ho-Young Yhim, Chonbuk National University Hospital
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 (Actual)
January 1, 2017
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
January 31, 2017
First Submitted That Met QC Criteria
February 1, 2017
First Posted (Estimate)
February 2, 2017
Study Record Updates
Last Update Posted (Actual)
August 7, 2019
Last Update Submitted That Met QC Criteria
August 5, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- nodal PTCL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Angioimmunoblastic T-cell Lymphoma
-
Navy General Hospital, BeijingChinese PLA General HospitalRecruitingRelapsed Angioimmunoblastic T-Cell Lymphoma | Refractory Angioimmunoblastic T-cell LymphomaChina
-
The Lymphoma Academic Research OrganisationCelgeneActive, not recruitingRelapsed Angioimmunoblastic T-Cell Lymphoma | Refractory Angioimmunoblastic T-cell LymphomaFrance, Denmark, United Kingdom, Austria, Belgium
-
Huijing WuBeijing Xisike Clinical Oncology Research Foundation; CSPC Pharmaceutical GroupRecruitingAngioimmunoblastic T-cell LymphomaChina
-
Sun Yat-sen UniversityNot yet recruitingAngioimmunoblastic T-cell LymphomaChina
-
Ruijin HospitalActive, not recruitingAngioimmunoblastic T-cell LymphomaChina
-
Peking Union Medical College HospitalBeijing Longfu HospitalNot yet recruitingAngioimmunoblastic T-cell LymphomaChina
-
University of NebraskaNational Cancer Institute (NCI); Spectrum Pharmaceuticals, IncCompletedPeripheral T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Hepatosplenic T-cell LymphomaUnited States
-
University of NebraskaNational Cancer Institute (NCI)CompletedAnaplastic Large Cell Lymphoma, ALK-Positive | Hepatosplenic T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | Anaplastic Large Cell Lymphoma, ALK-Negative | Stage II Angioimmunoblastic T-cell Lymphoma | Stage II Enteropathy-Associated T-Cell Lymphoma | Stage III Angioimmunoblastic... and other conditionsUnited States
-
Qingdao UniversityUnknownAngioimmunoblastic T-cell LymphomaChina
-
Ou Bai, MD/PHDSecond Hospital of Jilin University; China-Japan Union Hospital, Jilin UniversityRecruitingAngioimmunoblastic T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedChina