Lymphoma
Conditions
Keywords
questionnaire
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | through study completion, an average of 5 years | From the date of diagnosis to the date of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymphoma Specific Survival (LSS) | through study completion, an average of 5 years | Time elapsed from the date of diagnosis to the date of death from lymphoma (disease progression, relapse or new treatment for lymphoma, or death) |
| Progression-Free Survival (PFS) | through study completion, an average of 5 years | To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment |
| net survival | through study completion, an average of 5 years | To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment |
| response rate | through study completion, an average of 5 years | To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment |
| Duration of response | through study completion, an average of 5 years | To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment |
| Event Free Survival (EFS) | through study completion, an average of 5 years | Time elapsed from the date of diagnosis to the date of the first event that occurred (disease progression, relapse or new treatment for lymphoma, or death) |
| Duration of survival after progression | through study completion, an average of 5 years | To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment |
| Frequency of lymphoma transformation | through study completion, an average of 5 years | To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment |
| Frequency of secondary cancers | through study completion, an average of 5 years | To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment |
| Frequency of other chronic diseases | through study completion, an average of 5 years | To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment |
| questionnarire of Quality of Life FACT-LYM (Functional Assessment of Cancer Therapy-Lymphoma): score 0 to 4 | 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.questions regarding physical well-being, social/familial well-being, emotional well-being, functional well-being, additional questions specific to lymphoma |
| Time to next anti-lymphoma treatment (TTNLT) | through study completion, an average of 5 years | To enrich data on the prognostic role of associated genetic and epidemiological factors with clinical and epidemiological data from patients and to identify factors affecting disease progression, such as lifestyle and occupational factors, as well as the type of treatment |
Countries
Italy
Contacts
Primary ContactPier Luigi Zinzani, MD
Backup ContactCinzia Pellegrini, MD
Outcome results
None listed