MedDataX Logo

Multicentric and Retrospective Analysis of Adolescent Young Adult (AYA) Hodgkins' Lymphoma Patients

NCT ID: NCT05663983

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hodgkin Lymphoma Adolescent Behavior Chemotherapy Effect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AIEOP

This is a National Association for the treatment of pediatric patients with hematological or oncological disease

Description of therapeutical results

Intervention Type BEHAVIORAL

Comparison between two groups of patients treated in different realities (Pediatric Hospital or Adult General Hospital)

FIL

This is a National Association that brings together many centers with particular attention to the treatment of adult lymphomas

Description of therapeutical results

Intervention Type BEHAVIORAL

Comparison between two groups of patients treated in different realities (Pediatric Hospital or Adult General Hospital)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Description of therapeutical results

Comparison between two groups of patients treated in different realities (Pediatric Hospital or Adult General Hospital)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Associazione Italiana di Ematologia e Oncologia Pediatrica

UNKNOWN

Sponsor Role collaborator

Fondazione Italiana Linfomi

UNKNOWN

Sponsor Role collaborator

Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luigi Rigacci

Clinical Trial Office Campus Bio-Medico

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rigacci

Role: CONTACT

Phone: 00393408142040

Email: [email protected]

Donnini

Role: CONTACT

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AYA

Identifier Type: -

Identifier Source: org_study_id