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Status unknownNCT05663983Updated Dec 23, 2022

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

An observational study in Hodgkin Lymphoma, Adolescent Behavior and Chemotherapy Effect, sponsored by Campus Bio-Medico University. Status unknown. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2022-12-23.

Sponsored by Campus Bio-Medico University · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
600
Ages
15 Years to 24 Years
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Hodgkin Lymphoma
  • Adolescent Behavior
  • Chemotherapy Effect
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 600 is above the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
600 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • AIEOP

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

    Behavioral: Description of therapeutical results

  • FIL

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

    Behavioral: Description of therapeutical results

Interventions

  • BehavioralDescription of therapeutical results

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

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What researchers measure

Primary outcomes

  1. Overall survival according to different treatment.

    To evaluate if there are differences in treatment of pediatric or adult subset of patients

    Time frame: 2004 to 2016

Secondary outcomes

  1. Acute or late complications

    Comparing different treatments choice in an homogeneous group of patients

    Time frame: 2004 to 2016

  2. Progression free survival

    According to different treatment

    Time frame: 2004 to 2016

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05663983
Lead sponsor
Campus Bio-Medico University
Collaborators
Associazione Italiana di Ematologia e Oncologia Pediatrica, Fondazione Italiana Linfomi
Responsible party
Luigi Rigacci (Clinical Trial Office Campus Bio-Medico, Campus Bio-Medico University) — Principal investigator
First posted
Dec 23, 2022
Start date
Jan 2023 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Dec 2024 (estimated)
Last update
Dec 23, 2022

Study contacts

Rigacci
Contact
l.rigacci@policlinicocampus.it
00393408142040

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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