Clinical trial NCT06814925: Italian Study of Patients With Lymphoma
Official title: Italian Prospective Observational Cohort Study of Patients With Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Keywords: questionnaire
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1500 patients with lymphoma (about 500 cases of DLBCL, 360 of FL, 260 of CLL/SLL, 110 of MZL, 60 of PTCL e MCL, 40 of LPL/WM, 30 of MF and BL, and 15 of HCL e ALL)

Brief summary: 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.

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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: Event Free Survival (EFS)
timeFrame: through study completion, an average of 5 years
measure: Lymphoma Specific Survival (LSS)
timeFrame: through study completion, an average of 5 years
measure: Progression-Free Survival (PFS)
timeFrame: through study completion, an average of 5 years
measure: net survival
timeFrame: through study completion, an average of 5 years
measure: response rate
timeFrame: through study completion, an average of 5 years
measure: Duration of response
timeFrame: through study completion, an average of 5 years
measure: Time to next anti-lymphoma treatment (TTNLT)
timeFrame: through study completion, an average of 5 years
measure: Duration of survival after progression
timeFrame: through study completion, an average of 5 years
measure: Frequency of lymphoma transformation
timeFrame: through study completion, an average of 5 years
measure: Frequency of secondary cancers
timeFrame: through study completion, an average of 5 years
measure: Frequency of other chronic diseases
timeFrame: through study completion, an average of 5 years
measure: questionnarire of Quality of Life FACT-LYM (Functional Assessment of Cancer Therapy-Lymphoma): score 0 to 4
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Pier Luigi Zinzani, MD
role: PRINCIPAL_INVESTIGATOR
References: