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Impact of the Comprehensive Geriatric Assessment on the Quality of Life OF Elderly Patients (ONCO-AGING)

L

Lorenza Scotti

Status

Unknown

Conditions

Solid Tumor
Elderly Patients
Hematologic Malignancies

Study type

Observational

Funder types

Other

Identifiers

NCT04478916
ONCO-AGING

Details and patient eligibility

About

Impact of the Comprehensive Geriatric Assessment on the Quality of Life of elderly onco-hematologic patients' candidates for complex antitumoral therapies: clinical and biological correlatives

Full description

The screenings for the next 2 decades indicate an exponential increase in the incidence of neoplastic diseases in the elderly population. In order to successfully balance effectiveness and low toxicity of immunochemotherapy, a treatment personalisation based on an objective evaluation of fitness is therefore needed. The use of geriatric screening is a first step to rationalize decisions in this regard, the G8 tool has demonstrated the ability to identify patients and mostly to objectively separate elderly fragile patients from those who are fit. In that consideration, the individualization of the anticancer treatment based on a Comprehensive Geriatric Assessment (CGA) is desirable in elderly fragile patients with solid or haematological malignancy. Cancer mortality is constantly increasing after 65 years and the consequent increase in life expectancy favour the processes of cellular senescence. In this context G8 fragility assessment will take place in the screening test and by using the EORTC QLQ-C30C questionnaire to assess quality of life (QoL). The evaluation of senescent cells will be done by real-time PCR. Our aims are i) to evaluate the impact of the CGA on the QoL of elderly onco-haematological patients, candidates for complex therapies, that resulted as fragile at the G8 geriatric screening and ii) to evaluate the senescent cells in the peripheral blood of the patients enrolled in the study. The study is expected to contribute to precision medicine management of elderly patients and refine the therapeutic stratifications.

Enrollment

144 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged ≥ 65 years
  • Diagnosis of solid or hematologic cancer
  • Patients who are candidates for a first line therapy for advanced disease to be treated with biological target drugs, or candidates for integrated radiotherapy
  • Patient with G8 scores ≤ 14/17

Exclusion criteria

  • Patients aged less than 65 years
  • Patients who have received or currently in treatment for solid or hematologic cancer
  • Patient with G8 scores more than 14/17

Trial design

144 participants in 2 patient groups

Geriatric evaluation Group
Description:
Geriatric evaluation of the proportion of elderly patients in which the treatment is modified based on the complete geriatric assessment (CGA)
Control Group

Trial contacts and locations

1

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Central trial contact

Prof. Alessandra Gennari

Data sourced from clinicaltrials.gov

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