Hodgkin LymphomaNCT03131531
Bergamo Lymphoid Cancer Registry
An observational study of Hodgkin Lymphoma and Non Hodgkin Lymphoma, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Non Hodgkin Lymphoma, Myeloma
- What is being tested?
- Patient registry
- How many people
- 6,000 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2017to 23 Mar 2037
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Male or female patients 18 years or older
- Written informed consent
- Confirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma
Who cannot join
- Unconfirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Hematology and Bone Marrow Transplant Unit, A.O. Ospedale Papa Giovanni XXIII
Bergamo, 24127
Giuseppe Gritti, MD, PhD, +39.035.2673684, g.gritti@asst-pg23.it
Alessandro Rambaldi, MD
About this study
This registry has been established to gain a better understanding of the clinical and biological characteristics and outcome of patients with lymphoid cancer
Read the 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.
- Conditions
- Hodgkin Lymphoma, Non Hodgkin Lymphoma, Myeloma
- Being tested
- Patient registry
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient registryOther
Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures
| Study group | Role | What they receive |
|---|---|---|
| Hodgkin lymphoma | Not described Receives: Other: Patient registry | |
| Non-Hodgkin lymphoma | Not described Receives: Other: Patient registry | |
| Myeloma | Not described Receives: Other: Patient registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 years
Secondary outcomes (3)
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
Measured: 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
Measured: 20 years
Biological correlative studies
Association between clinical and biologic characteristics
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start23 Mar 2017
- Primary completion23 Mar 2027 (estimated)
- Study completion23 Mar 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rambaldi Alessandro, A.O. Ospedale Papa Giovanni XXIII
- Investigators
- Alessandro Rambaldi, MD, Principal investigator, A.O. Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131531
- Sponsor's protocol ID
- BLCR
- Status last verified
- Mar 2024
- First submitted
- 20 Apr 2017
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bergamo Lymphoid Cancer Registry
- ClinicalTrials.gov ID
- NCT03131531
- Acronym / sponsor ID
- BLCR
- Conditions
- Hodgkin Lymphoma, Non Hodgkin Lymphoma, Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 23 Mar 2037 (estimated)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hodgkin lymphoma | – | Other: Patient registry |
| Non-Hodgkin lymphoma | – | Other: Patient registry |
| Myeloma | – | Other: Patient registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- Male or female patients 18 years or older
- Written informed consent
- Confirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma
Key exclusion criteria (1 listed)
- Unconfirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient registryClinical data, specific procedures and treatments will follow the Institutional standard operative procedures | Other | Hodgkin lymphoma, Myeloma, Non-Hodgkin lymphoma |
Primary outcome
Overall survival
Time frame: 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
3 secondary outcomes
Disease-free survival
Time frame: 20 years
Progression-free survival
Time frame: 20 years
Biological correlative studies
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro Rambaldi, MD principal investigator
A.O. Ospedale Papa Giovanni XXIII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma and Non Hodgkin Lymphoma, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Rambaldi, MD (+39.035.2673683, arambaldi@asst-pg23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.