Bergamo Lymphoid Cancer Registry

Hodgkin Lymphoma Clinical Trial

Official title:

Bergamo Lymphoid Cancer Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03131531
• Other study ID #: BLCR
• Status: Recruiting
• Start date: March 23, 2017
• Est. completion date: March 23, 2037

Study information

• Verified date: March 2024
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Alessandro Rambaldi, MD
• Phone: +39.035.2673683
• Email: arambaldi[@]asst-pg23.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This registry has been established to gain a better understanding of the clinical and biological characteristics and outcome of patients with lymphoid cancer

Description:

Lymphoid cancer including Hodgkin disease, non-Hodgkin lymphomas (NHL) and myeloma, represents the most common hematologic malignancy. Despite the overall prognosis improved in the last 10 years, there are many open issues that need to be addressed, specifically refractoriness to standard treatment, disease recurrence and outcome with new drug in the so called "real world" setting. Since the Hematology and Bone Marrow Transplant Unit at "Ospedale Papa Giovanni XIII" of Bergamo has developed specific tools to collect clinical data thought fully validated electronic charts and biological specimens thanks to a regulatory compliant biobanking program, the aim of this study is to collect clinical and biological information of lymphoid cancer patients. The cohort of patients enrolled will permit to analyze the practice pattern, perform biological correlative studies of great translational potential with relevance to clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: March 23, 2037
• Est. primary completion date: March 23, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients 18 years or older
• Written informed consent
• Confirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma

Exclusion Criteria:

• Unconfirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma

Related Conditions & MeSH terms

• Hodgkin Lymphoma
• Lymphoma
• Myeloma
• Non Hodgkin Lymphoma

Intervention

Other:
• Patient registry
Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures

Locations

Country	Name	City	State
Italy	Hematology and Bone Marrow Transplant Unit, A.O. Ospedale Papa Giovanni XXIII	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Analyzed for all patients as time from diagnosis to death as a result of any cause, stratified according to intervention and baseline characteristics	20 years
Secondary	Disease-free survival	Analyzed only for patients in complete response, as time from achievement of the complete response to relapse or death due to disease or acute toxicity of treatment, stratified according to intervention and baseline characteristics	20 years
Secondary	Progression-free survival	Analyzed for all patients, as time from diagnosis to progression of disease or death as a result of any cause, stratified according to intervention and baseline characteristics	20 years
Secondary	Biological correlative studies	Association between clinical and biologic characteristics	20 years