Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587388
Status:
RECRUITING
Last Update Posted:
2020-10-14
First Post:
2020-10-08
Brief Title:
Towards Personalized Medicine for RefractoryRelapsed Follicular Lymphoma Patients the CanteraLupiae Registry
Sponsor:
European Hematology Association - Lymphoma Group
Organization:
European Hematology Association - Lymphoma Group
Study Overview
Official Title:
Towards Personalized Medicine for RefractoryRelapsed Follicular Lymphoma Patients the CanteraLupiae Registry
Status:
RECRUITING
Status Verified Date:
2020-10
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:
LUPIAE
Brief Summary:
The optimal treatment strategy in patients with early progressive disease is not well known In recent years novel insights into the biology of Follicular Lymphoma FL and especially the role of the microenvironment have resulted in the development of multiple novel treatment modalities These new agents may ultimately improve the outlook for patients with FL with an unfavorable course but for the development of the optimal therapeutic strategy knowledge on the clinical and biological determinants of early refractory FL is needed
Detailed Description:
Patients with histologically confirmed follicular lymphoma are registered in the study at the time of the first event after first line treatment An event is defined as refractoryrelapsed disease documented by biopsy imaging or clinical evaluation Registration is based on the locally established histological diagnosis with exclusion of cases diagnosed on fine needle aspiration cytology while tru-cut core-needle biopsies are permitted in the study Registration will be done on-line on a key restricted accessible web-database the Investigator must complete the on-line registration form after obtaining informed consent dated and signed by the patient
Investigators are requested to register consecutive cases diagnosed at each participating Institution all patients satisfying Inclusion criteria without any further selection A patient number Patient ID will be assigned strictly sequentially in ascending order as patients eligibility is verified In case a patients eligibility is not confirmed and the patient is withdrawn from the study the patient number will not be reused The assigned number will be used as the identification code for the subject
Every registered case has to undergo histopathology review by a panel of experts The reference pathologist will collect and review the pathology material sent by the participating centers without knowledge of the clinical outcome of the patient Both material obtained at diagnosis and at relapse will be reviewed Classification will be performed according to the World Health Organization recently published
Investigators are requested to register consecutive cases diagnosed at each participating Institution all patients satisfying Inclusion criteria without any further selection A patient number Patient ID will be assigned strictly sequentially in ascending order as patients eligibility is verified In case a patients eligibility is not confirmed and the patient is withdrawn from the study the patient number will not be reused The assigned number will be used as the identification code for the subject
Every registered case has to undergo histopathology review by a panel of experts The reference pathologist will collect and review the pathology material sent by the participating centers without knowledge of the clinical outcome of the patient Both material obtained at diagnosis and at relapse will be reviewed Classification will be performed according to the World Health Organization recently published
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