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NCT Number: NCT06814925

Italian Study of Patients With Lymphoma

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".

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: through study completion, an average of 5 years

    From the date of diagnosis to the date of death

Secondary outcomes

  1. Event Free Survival (EFS)

    Time frame: 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)

  2. Lymphoma Specific Survival (LSS)

    Time frame: 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)

  3. Progression-Free Survival (PFS)

    Time frame: 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

  4. net survival

    Time frame: 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

  5. response rate

    Time frame: 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

  6. Duration of response

    Time frame: 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

  7. Time to next anti-lymphoma treatment (TTNLT)

    Time frame: 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

  8. Duration of survival after progression

    Time frame: 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

  9. Frequency of lymphoma transformation

    Time frame: 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

  10. Frequency of secondary cancers

    Time frame: 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

  11. Frequency of other chronic diseases

    Time frame: 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

  12. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Cinzia Pellegrini, MD

CONTACT

[email protected]

+390512143680

Pier Luigi Zinzani, MD

CONTACT

[email protected]

+390512143680

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Italian Prospective Observational Cohort Study of Patients With Lymphoma

Acronym: LYMPH-OS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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