Italian Study of Patients With Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Italian Prospective Observational Cohort Study of Patients With Lymphoma
Overview
It is an observational, non-interventional, prospective, monocentric study, whose objective is to enroll 1500 patients with lymphoma in 5 years within the Institute of Hematology "Seragnoli".
Detailed description
The study is aimed at enriching the data on the prognostic role of genetic and epidemiological factors associated with clinical and epidemiological data of patients; to identify factors that influence the evolution of the disease, such as lifestyle and occupational factors, as well as the type of treatment; to document the impact of the disease on quality of life and to provide a platform for future research projects.
Study-specific questionnaires will be administered to patients, both at baseline and during follow-up, which methodologically represent a useful tool in order to achieve these objectives.
Primary outcome measures
- Overall Survival (OS) [Time frame: through study completion, an average of 5 years]
Secondary outcome measures (12)
- Event Free Survival (EFS) [Time frame: through study completion, an average of 5 years]
- Lymphoma Specific Survival (LSS) [Time frame: through study completion, an average of 5 years]
- Progression-Free Survival (PFS) [Time frame: through study completion, an average of 5 years]
- net survival [Time frame: through study completion, an average of 5 years]
- response rate [Time frame: through study completion, an average of 5 years]
- Duration of response [Time frame: through study completion, an average of 5 years]
- Time to next anti-lymphoma treatment (TTNLT) [Time frame: through study completion, an average of 5 years]
- Duration of survival after progression [Time frame: through study completion, an average of 5 years]
- Frequency of lymphoma transformation [Time frame: through study completion, an average of 5 years]
- Frequency of secondary cancers [Time frame: through study completion, an average of 5 years]
- Frequency of other chronic diseases [Time frame: through study completion, an average of 5 years]
- questionnarire of Quality of Life FACT-LYM (Functional Assessment of Cancer Therapy-Lymphoma): score 0 to 4 [Time frame: through study completion, an average of 5 years]
Eligibility criteria
Inclusion criteria
- Age greater than or equal to 18 years at enrollment
- Diagnosis of lymphoma within 3 months of enrollment
- Patients may have been treated, as long as the initial diagnosis of lymphoma is within 3 months of enrollment
- Signing of the informed consent form
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06814925 · LYMPH-OS