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Recruiting NCT06781437

Retrospective Observational Study of Italian Cohort of Lymphoma Patients (RETRO-LYMPH)

Observational Lymphoproliferative Syndrome, Autoimmune 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: Lymphoproliferative Syndrome, Autoimmune, 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 →
Official title

Studio Osservazionale Retrospettivo Di Coorte Italiana Di Pazienti Con Linfoma (RETRO-LYMPH)

Overview

observational, non-interventional, retrospective, single-center study focusing on patients with lymphoma / lymphoproliferative syndrome between January 1980 and September 2021

Detailed description

observational, non-interventional, retrospective, single-center study focusing on patients with lymphoma / lymphoproliferative syndrome between January 1980 and September 2021.

Study objectives are to enrich the data on the prognostic role of clinical and epidemiological factors associated with clinical and epidemiological data of patients;

* to identify the factors that affect the evolution of the disease, such as lifestyle and occupational factors, as well as the type of treatment; * to provide a platform for future research projects; * Description of the various therapies that have occurred over time, duration of treatment, causes of interruption of treatment, responses; * Description of the adverse events / safety of the various therapies for lymphoma and lymphoproliferative syndromes; * Patient survival. Descriptive analyses will be conducted by tabulating frequency distributions and percentages and mean and median values, standard deviations, quartiles and extreme values for continuous variables. Progression-free survival, disease-free survival and overall survival will be examined using Kaplan-Meier point estimates

Primary outcome measures

  • Incidence and prevalence of lymphomas/lymphoproliferative syndromes referred to the Centre between January 1980 and September 2021 [Time frame: through study completion, an average of 6 years]
Secondary outcome measures (12)
  • Overall Survival (OS) [Time frame: through study completion, an average of 6 years]
  • event free survival (EFS) [Time frame: through study completion, an average of 6 years]
  • Lymphoma specific survival (LSS) [Time frame: through study completion, an average of 6 years]
  • Progression Free Survival (PFS) [Time frame: through study completion, an average of 6 years]
  • Net survival (5 years) [Time frame: through study completion, an average of 6 years]
  • Response rate (5 years) [Time frame: through study completion, an average of 6 years]
  • Duration of Response (DoR) [Time frame: through study completion, an average of 6 years]
  • time to next anti-lymphoma treatment (TTNLT) [Time frame: through study completion, an average of 6 years]
  • Duration of survival after progression [Time frame: through study completion, an average of 6 years]
  • lymphoma transformation frequency [Time frame: through study completion, an average of 6 years]
  • Frequency of secondary neoplasy [Time frame: through study completion, an average of 6 years]
  • frequency of other chronic diseases [Time frame: through study completion, an average of 6 years]

Eligibility criteria

Inclusion criteria

  • Age greater than or equal to 18 years of enrollment
  • Diagnosis of lymphoma or lymphoproliferative syndrome between January 1980 and September 2021
  • Signature of the informed consent form where applicable

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: NCT06781437 · RETRO-LYMPH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗