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

Fondazione Italiana Linfomi - ETS44 sites in 1 country400 target enrollmentAugust 10, 2018

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

August 10, 2018

End Date

January 2026

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Fondazione Italiana Linfomi - ETS

Responsible Party

Sponsor

Eligibility Criteria

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

Not provided

Outcomes

Primary Outcomes

OS

Time Frame: June 2018-December 2025 (7.5 years)

Overall survival (OS). From the date of diagnosis to the date of last observation or death from any cause

Secondary Outcomes

PFS(June 2018-December 2025 (7.5 years))
FFS(June 2018-December 2025 (7.5 years))
Response initial therapy(June 2018-January 2024 (5.5 years, 6-7 month after the enrolment))