Bergamo Lymphoid Cancer Registry

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

Study Overview

• Status: Recruiting
• Conditions: Hodgkin Lymphoma; Non Hodgkin Lymphoma; Myeloma
• Intervention / Treatment: Other: Patient registry

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Alessandro Rambaldi, MD; Phone Number: +39.035.2673683; Email: arambaldi@asst-pg23.it
• Study Contact Backup: Name: Giuseppe Gritti, MD, PhD; Phone Number: +39.035.2673679; Email: g.gritti@asst-pg23.it

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • Hematology and Bone Marrow Transplant Unit, A.O. Ospedale Papa Giovanni XXIII
    • Contact: Giuseppe Gritti, MD, PhD; Phone Number: +39.035.2673684; Email: g.gritti@asst-pg23.it
    • Sub-Investigator: Giuseppe Gritti, MD, PhD
    • Principal Investigator: Alessandro Rambaldi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients eligible for this study are patients with a diagnosis of lymphoid cancer in charge of the Hematology and Bone Marrow Transplant Unit "Ospedale Papa Giovanni XIII" of Bergamo.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hodgkin lymphoma	Other: Patient registry; Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures
Non-Hodgkin lymphoma	Other: Patient registry; Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures
Myeloma	Other: Patient registry; Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Biological correlative studies	Association between clinical and biologic characteristics	20 years

Collaborators and Investigators

• Sponsor: A.O. Ospedale Papa Giovanni XXIII
• Investigators: Principal Investigator: Alessandro Rambaldi, MD, A.O. Ospedale Papa Giovanni XXIII

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): March 23, 2037

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: BLCR

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