Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis

Study Overview
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Brief Summary
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The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA)

Detailed Description
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The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA) Prospective data collection study of a consecutive series of newly diagnosed elderly cHL patients undergoing CGA before any therapy with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study. Patients will be screened and restaged according to clinical practice instrumental and laboratory assessments timing and type of examinations.

Official Title
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Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis

Conditions
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Classical Hodgkin Lymphoma

Intervention / Treatment
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* Other: Treatment for clinical practise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of classical Hodgkin Lymphoma Age ≥ 65 year Evaluation of Comprehensive Geriatric Assessment at baseline Signed informed consent Previously untreated patients Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed elderly cHL patients<br>Newly diagnosed elderly cHL patients undergoing CGA before any therapy (treatment for clinical practise) with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study | Other: Treatment for clinical practise<br>* Prospective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival (OS). From the date of diagnosis to the date of last observation or death from any cause | June 2018-December 2025 (7.5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival (PFS): From the date of diagnosis to the last follow-up, or to one of the following events: disease progression during treatment, or relapse, or death from any cause. | June 2018-December 2025 (7.5 years) | 
| FFS | Failure Free Survival (FFS). From the date of diagnosis to to any treatment failure including disease progression, or discontinuation of treatment for any reason, (eg, disease progression, toxicity, patient preference, initiation of new treatment), or death from any cause. | June 2018-December 2025 (7.5 years) | 
| Response initial therapy | Response initial therapy: Rate of complete remission (CR) after chemotherapy +/-RT, according to Cheson 2007 | June 2018-January 2024 (5.5 years, 6-7 month after the enrolment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGA, Hodgkin, Elderly patients