- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07374068
Prognostic Model of Elderly Hodgkin Lymphoma in China
Clinical Characteristics and Prognostic Model Analysis of Elderly Patients With Hodgkin Lymphoma in China
This multicenter observational cohort study is based on a patient registry designed to systematically collect uniform real-world clinical data from elderly patients with Hodgkin lymphoma (HL) in China. The registry captures demographic characteristics, disease features, laboratory parameters, treatment patterns, and longitudinal survival outcomes to support predefined scientific objectives.
The primary analysis uses retrospectively collected registry data, with prospectively accrued data incorporated for external validation of a prognostic prediction model. This registry-based study aims to improve risk stratification and inform individualized clinical decision-making for elderly patients with HL in routine clinical practice.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China, 300060
- Tianjin Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population consists of elderly patients aged 60 years or older with histologically confirmed Hodgkin lymphoma. Eligible patients include those diagnosed with classical Hodgkin lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma who were treatment-naïve at initial diagnosis.
All patients have complete clinical, pathological, and follow-up data available. Patients with other concurrent malignant tumors, severe hepatic or renal dysfunction, or missing more than 20% of required clinical data are excluded from the study.
Description
Inclusion Criteria:
- Age ≥60 years
- Histologically confirmed Hodgkin lymphoma, including classical Hodgkin lymphoma and nodular lymphocyte-predominant Hodgkin lymphoma
- Treatment-naïve patients who have not received prior anti-Hodgkin lymphoma therapy
- Availability of complete clinical, pathological, and follow-up data
Exclusion Criteria:
- Presence of other malignant tumors
- Severe hepatic or renal dysfunction (Child-Pugh class C or estimated glomerular filtration rate <30 mL/min)
- Missing more than 20% of required clinical data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Elderly patients with Hodgkin lymphoma
Observational Cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: From date of diagnosis until death from any cause, assessed up to 60 months.
|
Overall survival (OS) is defined as the time from diagnosis to death from any cause.
|
From date of diagnosis until death from any cause, assessed up to 60 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-Free Survival (PFS)
Time Frame: From date of diagnosis until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
|
Progression-free survival (PFS) is defined as the time from diagnosis to disease progression or death from any cause.
|
From date of diagnosis until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 months.
|
|
Disease-Free Survival (DFS)
Time Frame: From date of first documented remission until disease relapse or death from any cause, whichever occurs first, assessed up to 60 months.
|
Disease-free survival (DFS) is defined as the time from remission to disease relapse or death from any cause.
|
From date of first documented remission until disease relapse or death from any cause, whichever occurs first, assessed up to 60 months.
|
|
Event-Free Survival (EFS)
Time Frame: From date of diagnosis until treatment failure, disease relapse, or death from any cause, whichever occurs first, assessed up to 60 months.
|
Event-free survival (EFS) is defined as the time from diagnosis to treatment failure, disease relapse, or death from any cause.
|
From date of diagnosis until treatment failure, disease relapse, or death from any cause, whichever occurs first, assessed up to 60 months.
|
|
Proportion of Participants With Disease Progression or Death Within 24 Months From Diagnosis (POD24)
Time Frame: From date of diagnosis to 24 months after diagnosis.
|
Progression of disease within 24 months (POD24) is defined as the occurrence of documented disease progression or death from any cause within 24 months from the date of diagnosis.
|
From date of diagnosis to 24 months after diagnosis.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCH-HL-ELDER-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Hodgkin Lymphoma
-
Marker Therapeutics, Inc.RecruitingHodgkin Lymphoma | Non Hodgkin Lymphoma | Hodgkin Lymphoma, Adult | Non-Hodgkin Lymphoma, Adult | Non-Hodgkin Lymphoma, Refractory | Non-Hodgkin Lymphoma, Relapsed | Hodgkin's Lymphoma, Relapsed, AdultUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Adult Hodgkin Lymphoma | Stage III Adult Hodgkin Lymphoma | Stage IV Adult Hodgkin Lymphoma | Recurrent/Refractory Childhood Hodgkin Lymphoma | Stage III Childhood Hodgkin Lymphoma | Stage IV Childhood Hodgkin Lymphoma | Stage I Adult Hodgkin Lymphoma | Stage I Childhood Hodgkin Lymphoma | Stage II Adult Hodgkin Lymphoma and other conditionsUnited States
-
Rita AssiRecruitingB-cell Lymphoma | Refractory Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Relapsed Non-Hodgkin Lymphoma | Relapsed Hodgkin LymphomaUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingAnn Arbor Stage III Hodgkin Lymphoma | Ann Arbor Stage IIIA Hodgkin Lymphoma | Ann Arbor Stage IIIB Hodgkin Lymphoma | Ann Arbor Stage IV Hodgkin Lymphoma | Ann Arbor Stage IVA Hodgkin Lymphoma | Ann Arbor Stage IVB Hodgkin Lymphoma | Classic Hodgkin Lymphoma | Ann Arbor Stage IB Hodgkin Lymphoma | Ann... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Adult Hodgkin Lymphoma | Adult Lymphocyte Depletion Hodgkin Lymphoma | Adult Lymphocyte Predominant Hodgkin Lymphoma | Adult Mixed Cellularity Hodgkin Lymphoma | Adult Nodular Sclerosis Hodgkin Lymphoma | Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma | Adult Favorable Prognosis... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin LymphomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage III Childhood Hodgkin Lymphoma | Stage IV Childhood Hodgkin Lymphoma | Stage I Childhood Hodgkin Lymphoma | Stage II Childhood Hodgkin Lymphoma | Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma | Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma | Childhood Mixed Cellularity... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland, Israel
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingClassic Hodgkin Lymphoma | Ann Arbor Stage IB Hodgkin Lymphoma | Ann Arbor Stage II Hodgkin Lymphoma | Ann Arbor Stage IIA Hodgkin Lymphoma | Ann Arbor Stage IIB Hodgkin Lymphoma | Ann Arbor Stage I Hodgkin Lymphoma | Ann Arbor Stage IA Hodgkin LymphomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingAnn Arbor Stage IIIB Hodgkin Lymphoma | Ann Arbor Stage IVA Hodgkin Lymphoma | Ann Arbor Stage IVB Hodgkin Lymphoma | Classic Hodgkin Lymphoma | Ann Arbor Stage IIB Hodgkin Lymphoma | Childhood Hodgkin LymphomaUnited States, Canada, Puerto Rico
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Recurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States