Bergamo Lymphoid Cancer Registry | NCT03131531

Studies
Bergamo Lymphoid Cancer Registry

NCT03131531

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Status

Recruiting

Last Update Posted

Mar 6, 2024Actual

Enrollment

6,000Estimated

Phase

Not provided

Conditions

Hodgkin Lymphoma
Non Hodgkin Lymphoma
Myeloma

Interventions

Patient registry

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2017Actual

Primary Completion Date

Mar 23, 2027Estimated

Completion Date

Mar 23, 2037Estimated

First Submitted Date

Apr 20, 2017

First Submission Date that Met QC Criteria

Apr 24, 2017

First Posted Date

Apr 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

6,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hodgkin lymphoma			Other: Patient registry
Non-Hodgkin lymphoma			Other: Patient registry
Myeloma			Other: Patient registry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient registry	Other	Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures	Hodgkin lymphoma Myeloma

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alessandro Rambaldi, MD	Contact	+39.035.2673683		arambaldi@asst-pg23.it
Giuseppe Gritti, MD, PhD	Contact	+39.035.2673679		g.gritti@asst-pg23.it

Overall Officials

Name	Affiliation	Role
Alessandro Rambaldi, MD	A.O. Ospedale Papa Giovanni XXIII	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hematology and Bone Marrow Transplant Unit, A.O. Ospedale Papa Giovanni XXIII	Recruiting	Bergamo		24127	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease
D008228	Lymphoma, Non-Hodgkin
D054219	Neoplasms, Plasma Cell

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided