AzTrials
AzTrials

Hematologic MalignanciesONCO-AGINGNCT04478916

Impact of the Comprehensive Geriatric Assessment on the Quality of Life OF Elderly Patients

An observational study of Hematologic Malignancies and Solid Tumor, run by Lorenza Scotti at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 65 years and older
How many people
144 participants
Where
1 siteItaly
Study dates
18 Dec 2019to May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: In the present study, only patients aged ≥ 65 years, with diagnosis of solid or hematologic cancer are eligible. Main inclusion criteria are two; i) patients who are candidates for a first line therapy for advanced disease to be treated with biological target drugs, or candidates for integrated radiotherapy; ii) patient with G8 scores ≤ 14/17

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Prof. Alessandra Gennari contact

+39 0321 3732292

alessandra.gennari@med.uniupo.it

Italy1 site, 1 recruiting

  • Università del Piemonte Orientale - Azienda Ospedliero-Universitaria Maggiore della Carita'

    Novara, 28100

    Prof. Alessandra Gennari, +39 0321 3732292, alessandra.gennari@med.uniupo.it

    Prof. Alessandra Gennari

    Recruiting

Other trials in Italy

About this study

Official title: 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

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

Read the detailed 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.

Keywords
Onco-hematologic diseases, Comprehensive Geriatric Assessment (CGA), Screening tool G8, Geriatric Medicine, Precision Medicine, Senescence
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04478916
Study groupRoleWhat they receive
Geriatric evaluation GroupGeriatric evaluation of the proportion of elderly patients in which the treatment is modified based on the complete geriatric assessment (CGA)
Control GroupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients received planned treatment and CGA evaluated with improvement of good quality of life (QOL)

    To assess the impact of the inclusion of the CGA on the quality of life (QOL) of the elderly onco-hematology patient that result frail in the geriatric screening (G8), compared to the clinical practice that does not include the CGA

    Measured: 12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months)

Secondary outcomes (5)

  1. Number of patients received radiotherapy planned and CGA evaluated with improvement of good quality of life (QOL)

    Part of patients receiving radiotherapy will be randomised to be evaluated using CGA compared to control group, the CGA assessment will be done using the status of ADL, IADL, QOL, MNA, SVI, GDS, CIRS, TC, MMSE, CDT, MOCA, RFI, VMD, at baseline and would be re-evaluated after every 6 month and If necessary, an onco-geriatric follow-up will be carried out, for the re-evaluation and further correction of the areas of fragility. A description of the changes of the above scales would also be recorded for the patients

    Measured: 12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months)

  2. Progression free survival (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

    Measured: From randomisation (December 2019-December 2022)

  3. Failure Free Survival (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

    Measured: From randomisation (December 2019-December 2022)

  4. Occurrence of dose reductions

    Data will be collected by reviewing patients medical charts

    Measured: From randomisation through study completion, an average of 1 year

  5. Overall Survival (OS)

    From the date of diagnosis to the last patient last visit

    Measured: From randomisation (December 2019-December 2022)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start18 Dec 2019
  3. Primary completionSep 2021 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04478916
Sponsor's protocol ID
ONCO-AGING
Acronym
ONCO-AGING
Status last verified
Jul 2020
First submitted
15 Jul 2020
Last updated
28 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mahmoud AM, Biello F, Maggiora PM, Bruna R, Burrafato G, Cappelli M, Varughese F, Martini V, Platini F, Deambrogi C, Patriarca A, Nicolosi M, Vachanaram AR, Pisani C, Ferrara E, Catania E, Azzolina D, Barone-Adesi F, Krengli M, Gaidano G, Gennari A. A randomized clinical study on the impact of Comprehensive Geriatric Assessment (CGA) based interventions on the quality of life of elderly, frail, onco-hematologic patients candidate to anticancer therapy: protocol of the ONCO-Aging study. BMC Geriatr. 2021 May 19;21(1):320. doi: 10.1186/s12877-021-02237-3.

    PubMed 34011271

Questions about this trial

What is this clinical trial studying?

An observational study of Hematologic Malignancies and Solid Tumor, run by Lorenza Scotti at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Prof. Alessandra Gennari (+39 0321 3732292, alessandra.gennari@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients received planned treatment and CGA evaluated with improvement of good quality of life (QOL) (time frame: 12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04478916, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in