Bergamo Lymphoid Cancer Registry

Sponsor

A.O. Ospedale Papa Giovanni XXIII (Other)

Overall Status

Recruiting

CT.gov ID

NCT03131531

Collaborator

(none)

6,000

Enrollment

Location

240

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma Non Hodgkin Lymphoma Myeloma	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

6000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Bergamo Lymphoid Cancer Registry

Actual Study Start Date :

Mar 23, 2017

Anticipated Primary Completion Date :

Mar 23, 2027

Anticipated Study Completion Date :

Mar 23, 2037

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Overall survival [20 years]
Analyzed for all patients as time from diagnosis to death as a result of any cause, stratified according to intervention and baseline characteristics

Secondary Outcome Measures

Disease-free survival [20 years]
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
Progression-free survival [20 years]
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
Biological correlative studies [20 years]
Association between clinical and biologic characteristics

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology and Bone Marrow Transplant Unit, A.O. Ospedale Papa Giovanni XXIII	Bergamo		Italy	24127

Sponsors and Collaborators

A.O. Ospedale Papa Giovanni XXIII

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rambaldi Alessandro, Prof., A.O. Ospedale Papa Giovanni XXIII

ClinicalTrials.gov Identifier:

NCT03131531

Other Study ID Numbers:

BLCR

First Posted:

Apr 27, 2017

Last Update Posted:

Dec 23, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Study Results

No Results Posted as of Dec 23, 2021