Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294652
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-28
Brief Title:
AGMT Austrian Lymphoma Registry
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Organization:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Overview
Official Title:
AGMT Austrian Lymphoma Registry
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lymphomas are a group of cancers that originate in the lymphatic system a key component of the immune system They can be broadly categorized into two main types Hodgkin lymphoma HL and non-Hodgkin lymphoma NHL
There are different subtypes of HL including classical Hodgkin lymphoma cHL and nodular lymphocyte-predominant Hodgkin lymphoma NLPHL The subtypes of cHL include nodular sclerosis mixed cellularity lymphocyte-rich and lymphocyte-depleted
Non-Hodgkin lymphomas are more diverse and comprise a wide range of subtypes each with distinct genetic molecular and clinical features Common subtypes of NHL include Diffuse large B-cell lymphoma DLBCL Follicular lymphoma FL Mantle cell lymphoma MCL Chronic lymphocytic leukemia CLL myeloma and other rarer subgroups
Many of these diseases typically present with lymph node enlargement bone marrow infiltration general and lymphoma subtype specific symptoms and laboratory abnormalities
Novel agents have improved the prognosis of high-risk lymphoma patients in the front-line and relapsed setting and more accurate prognostic tools enable less intensive treatment for low-risk patients while maintaining their good prognosis
Lymphoma disease have not been systematically assessed in Austria to date This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of epidemiology clinical course and molecular and other biologic data of this disease As lymphomas are a very heterogeneous group not all subtypes will always be documented simultaneously in this registry Which lymphoma subtype is to be documented can change over time depending on which clinical question is currently in focus
There are different subtypes of HL including classical Hodgkin lymphoma cHL and nodular lymphocyte-predominant Hodgkin lymphoma NLPHL The subtypes of cHL include nodular sclerosis mixed cellularity lymphocyte-rich and lymphocyte-depleted
Non-Hodgkin lymphomas are more diverse and comprise a wide range of subtypes each with distinct genetic molecular and clinical features Common subtypes of NHL include Diffuse large B-cell lymphoma DLBCL Follicular lymphoma FL Mantle cell lymphoma MCL Chronic lymphocytic leukemia CLL myeloma and other rarer subgroups
Many of these diseases typically present with lymph node enlargement bone marrow infiltration general and lymphoma subtype specific symptoms and laboratory abnormalities
Novel agents have improved the prognosis of high-risk lymphoma patients in the front-line and relapsed setting and more accurate prognostic tools enable less intensive treatment for low-risk patients while maintaining their good prognosis
Lymphoma disease have not been systematically assessed in Austria to date This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of epidemiology clinical course and molecular and other biologic data of this disease As lymphomas are a very heterogeneous group not all subtypes will always be documented simultaneously in this registry Which lymphoma subtype is to be documented can change over time depending on which clinical question is currently in focus
Detailed Description:
This registry is designed as international multicenter observational cohort of patients with lymphoma Information on patients clinical presentation tests diagnosis and treatment will be obtained through extraction of data from existing patient medical charts Longitudinal follow-up data including survival and tumor progression will also be extracted from patient medical charts This patient follow-up data will be obtained until patient death or loss to follow-up
For documentation in the registry no further diagnostic or therapeutic measures are required than those already necessary in general Participation in the registry must not interfere with treatment routines Only routine data which has already been recorded in the patients medical chart is transferred to the electronic Case Report Forms eCRF To maintain patient confidentiality each patient will be assigned a unique patient identifying number upon enrollment this number will accompany the patients medical and other registry information throughout the lifetime of the registry
A written consent must be obtained prior to the input of data No informed consent is required from deceased patients
For documentation in the registry no further diagnostic or therapeutic measures are required than those already necessary in general Participation in the registry must not interfere with treatment routines Only routine data which has already been recorded in the patients medical chart is transferred to the electronic Case Report Forms eCRF To maintain patient confidentiality each patient will be assigned a unique patient identifying number upon enrollment this number will accompany the patients medical and other registry information throughout the lifetime of the registry
A written consent must be obtained prior to the input of data No informed consent is required from deceased patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None