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Solid CarcinomaPROGNOSIS-G8NCT04644874

Geriatric Oncology Screening of Older Patients With Solid Cancers

An observational study of Solid Carcinoma and Frailty, run by Odense University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Older patients with cancer constitute a heterogeneous group with varying comorbidity; therefore, geriatric assessment with initial screening is recommended. The Geriatric 8 (G8) has been established as a promising screening tool. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Solid Carcinoma, Frailty, Age
What is being tested?
Geriatric 8, modified Geriatric 8 and 30 second chair stand test
How many people
1,401 participants
Where
1 siteDenmark
Study dates
3 Jun 2020to 15 Nov 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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: All outpatients, age 70 years or more with solid malignancies, referred to the Department of Oncology at Odense University Hospital for antineoplastic treatment or information

Who may be able to join

  • Patients age ≥70 with solid tumors (not hematological malignancies nor non-melanoma skin cancer) referred to the outpatient clinic at Odense University Hospital for information and/or antineoplastic treatment
  • Patients must be able to give informed consent
  • Patients must be able to speak English or Danish

Who cannot join

  • Patients who have received antineoplastic treatment for another cancer diagnosis within the past year
  • Patients who have begun chemotherapy or immunotherapy for the referred cancer diagnosis, more than 48 hours prior to the time of consent
  • Patients who have begun other antineoplastic treatment (not endocrine) for the referred cancer diagnosis, more than 7 days prior to the time of consent

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Odense University Hospital

    Odense, Fyn, 5000

Other trials in Denmark

About this study

Official title: Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers: A Prospective G8 Study

Older patients with cancer constitute a heterogeneous group with varying comorbidity; therefore, geriatric assessment with initial screening is recommended. The Geriatric 8 (G8) has been established as a promising screening tool. Currently, there are no guidelines for oncogeriatric screening in older cancer patients in Denmark. We hypothesize that by screening persons age 70 years or more with newly diagnosed cancer, with the G8, we can assess the prognostic value and identify a subgroup of patients who will benefit from a CGA.

Aims:

Read more
  • Determine whether Danish cancer patients, with a G8 score of ≤14, experience poorer quality of life (QoL), receive less recommended standard cancer treatment, experience more treatment-related toxicity, stop treatment earlier, and experience shorter survival than patients with a G8 score >14.
  • Ascertain whether the standard G8 cut-off score of ≤14 is the most relevant cut-off score, with respect to treatment adherence, treatment-related toxicity, QoL, and survival, when focusing on the older Danish cancer patient population.
  • Establish whether the performance and prognostic value of the G8 can be strengthened through the addition of a functional measure, the 30-second chair stand test (30-CST), and/ or the handgrip strength test (HGST).
  • Evaluate the prognostic value of the modified Geriatric 8 (mG8)

Methods:

A prospective, descriptive study of all outpatients with newly diagnosed solid tumors at the Department of Oncology, Odense University Hospital, age 70 years or more. Patients will be screened with the G8, mG8, 30-CST, HGST, and QoL questionnaires at baseline with subsequent one-year follow-up, to determine the prognostic value of the G8 and the mG8. An initial two-month pilot study will help determine inclusion rates and highlight necessary practical adjustments to ensure optimal study participation. Baseline characteristics will be compared with descriptive statistics. Our primary endpoint; Global Health status/ QoL (EORTC QLQ-C30 \& QLQ-ELD14), and secondary endpoints; treatment adherence, and treatment-related toxicity, will be assessed using logistical regression; while secondary endpoints; overall survival, cancer-specific survival, will be assessed using the Kaplan Meier analysis and Cox proportional hazard models. Post hoc diagnostic performance analysis will be conducted to determine the optimal G8 cut-off and whether functional measures (30-CST and HGST) can enhance screening accuracy.

Being tested
Geriatric 8, modified Geriatric 8, 30 second chair stand test, Handgrip Strength Test
Keywords
Older adults, Cancer patients, Neoplasms, Frailty, Comprehensive geriatric assessment, Geriatric screening, Geriatric 8, modified Geriatric 8, G8, mG8, elderly, screening
Medical subject headings
Frailty, Neoplasms

What participants receive

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

  • Geriatric 8Diagnostic test

    Also called G8

    The G8 is an eight-item screening tool, developed for older cancer patients. The G8 score ranges from 0 (heavily impaired) to 17 (not at all impaired), with a cut-off for potential frailty of ≤14.

  • modified Geriatric 8Diagnostic test

    Also called mG8

    The mG8 is a modified version of the Geriatric 8 screening tool, consisting of 6-items. The mG8 score ranges from 0 (not at all impaired) to 35 (heavily impaired), with a cut-off for potential frailty at ≥6.

  • 30 second chair stand testDiagnostic test

    Also called 30s-CST, chair stand test, 30 CST, CST

    Repetitions within 30 seconds

  • Handgrip Strength TestDiagnostic test

    Also called HGST, HST

    Measured in kilograms

Study groups in NCT04644874
Study groupRoleWhat they receive
Older cancer patientsAll outpatients, age 70 years or more, with solid malignancies, referred to the Department of Oncology at Odense University Hospital for 1st line antineoplastic treatment or information,
Receives: Diagnostic Test: Geriatric 8; Diagnostic Test: modified Geriatric 8; Diagnostic Test: 30 second chair stand test; Diagnostic Test: Handgrip Strength Test

What is being measured

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

  1. Global health status / Quality of Life

    Global health status will be described using EORTC QLQ-C30

    Measured: 12 months

Secondary outcomes (8)

  1. Health-related Quality of Life (HRQoL)

    HRQoL is measured by EORTC QLQ-C30

    Measured: 12 months

  2. Health-related Quality of Life (HRQoL)

    HRQoL is measured by EORTC QLQ-ELD14 (ELderly Cancer Patients Module)

    Measured: 12 months

  3. Overall Survival

    Overall Survival is measured from Geriatric 8 screening to time of death

    Measured: 12 months

  4. Cancer-specific Survival

    Cancer-specific Survival is measured from Geriatric 8 screening to time of death in patients with residual cancer

    Measured: 12 months

  5. Adherence to initial oncologic treatment plan

    Deviation from initial oncologic treatment plan with the registration of dose reductions, with the given dose measured as a percentage of the planned dose.

    Measured: 12 months

  6. Adherence to initial oncologic treatment plan

    Deviation from initial oncologic treatment plan with the registration of dose delays, measured in days.

    Measured: 12 months

  7. Adherence to initial oncologic treatment plan

    Deviation from initial oncologic treatment plan with the registration of discontinuation of treatment, measured as the number of given cycles divided by the number of planned cycles.

    Measured: 12 months

  8. Performance analysis of the Geriatric 8

    Performance analysis will be conducted using patients allocated to Comprehensive Geriatric Assessment (CGA), where an abnormal CGA will be defined as >1 abnormal domain, in accordance with the Danish version of the Geriatric Core Dataset (G-Code).

    Measured: 12 months

Timeline

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

  1. First posted25 Nov 2020
  2. Study start3 Jun 2020
  3. Primary completion15 Nov 2022
  4. Study completion15 Nov 2022

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
1,401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04644874
Sponsor's protocol ID
PROGNOSIS-G8
Other IDs
R247-A14382, 20/ 17768
Acronym
PROGNOSIS-G8
Status last verified
Nov 2023
First submitted
12 Nov 2020
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ditzel HM, Giger AW, Lund CM, Ditzel HJ, Moller S, Pfeiffer P, Ryg J, Ewertz M, Jorgensen TL. Association between Geriatric 8 frailty and overall survival, treatment intensity, and treatment tolerance in older patients with cancer (PROGNOSIS-G8). J Geriatr Oncol. 2026 Jul;17(6):103021. doi: 10.1016/j.jgo.2026.103021. Epub 2026 May 29.

    PubMed 42208483

  • Ditzel HM, Giger AW, Lund CM, Ditzel HJ, Mohammadnejad A, Pfeiffer P, Ryg J, Jorgensen TL, Ewertz M. Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients with Solid Cancers: Protocol for a Danish prospective cohort study (PROGNOSIS-G8). J Geriatr Oncol. 2021 Nov;12(8):1270-1276. doi: 10.1016/j.jgo.2021.06.004. Epub 2021 Jun 25.

    PubMed 34176752

Questions about this trial

What is this clinical trial studying?

An observational study of Solid Carcinoma and Frailty, run by Odense University Hospital at 1 site in Denmark.

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 3 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: finished, as of the sponsor's last update on 15 Nov 2023. 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 Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global health status / Quality of Life (time frame: 12 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 NCT04644874, which also lists 2 linked publications.

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 15 Nov 2023.

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