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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05663983
Other study ID # AYA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2023
Est. completion date December 2024

Study information

Verified date December 2022
Source Campus Bio-Medico University
Contact Rigacci
Phone 00393408142040
Email l.rigacci@policlinicocampus.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The principal aim of this study is to collect retrospectively all Adolescent Young Adult patients affected by Hodgkin's Lymphoma and treated in pediatric or adult haemato-oncology Centers. The data set collection aims to define the therapy performed and the results obtained in terms of overall survival and acute or late complications.


Description:

Hodgkin lymphoma (HL) represents approximately 0.5% of cancer diagnosis each year in developed countries (1, 2). This translates to an annual incidence of 8500 individuals per year in the United States and an incidence rate of 2.49 per 100.000 lymphoid malignancies in Europe (2, 3). A classical bimodal distribution is reported with a first peak occurring in patients between the ages of 15 and 30 years and a second peak in those older than 55 years (4). HL is one of the most common malignancies to occur in the adolescent and young adult (AYA) population. This population is defined by the National Cancer Institute as people diagnosed with cancer between the ages of 15 and 39 years. The choice of therapy for AYA patients is typically determined by the treatment setting and referral patterns. Patients who are younger than 18 years are usually referred to pediatric Centers, where many patients are treated in the context of clinical trials. For patients treated by adult haematologists many are treated in the community setting. Considerable variability exists between the treatment of adult and pediatric patients, including the choice of chemotherapeutic agents and the role of radiation. In both the pediatric and adult settings there has been increasing focus on balancing the risk of relapse with the risk of secondary side effects. De-intensification for low-risk patients using PET-adapted strategies is a modern approach that has been applied to all patients with HL independent of age. Variability among age groups still results in uncertainty regarding the optimal treatment approach in the AYA population. This is a retrospective observational study involving Italian Centers that treat adolescents and young adults Hodgkin lymphoma patients. This type of patients can be treated either in a Pediatric Institution or in Adult Institution with different supportive and therapeutical approaches. The primary objectives will be overall survival according to different treatment. Secondary end points will be acute or late complications comparing different treatments choice in an homogeneous group of patients, progression free survival according to different treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years to 24 Years
Eligibility Inclusion Criteria: - All consecutive patients with diagnosis of Hodgkin Lymphoma with an age at diagnosis ranging between 15 and 24 years enrolled in prospective studies either in AIEOP group and in FIL group or patients treated consecutively in single centers affiliated to AIEOP or FIL and registered in single institutional data base. - All Hodgkin subtype Exclusion Criteria: - None

Study Design


Intervention

Behavioral:
Description of therapeutical results
Comparison between two groups of patients treated in different realities (Pediatric Hospital or Adult General Hospital)

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Campus Bio-Medico University Associazione Italiana di Ematologia e Oncologia Pediatrica, Fondazione Italiana Linfomi

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival according to different treatment. To evaluate if there are differences in treatment of pediatric or adult subset of patients 2004 to 2016
Secondary Acute or late complications Comparing different treatments choice in an homogeneous group of patients 2004 to 2016
Secondary Progression free survival According to different treatment 2004 to 2016
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