NCT04644874: PROGNOSIS-G8

Geriatric Oncology Screening of Older Patients With Solid Cancers

Completed Last updated 15 November 2023

What this trial tests

trial testing Geriatric 8 in Solid Carcinoma in 1,401 participants. Completed in 15 November 2022.

Timeline

3 June 2020

Primary endpoint
15 November 2022

15 November 2022

Quick facts

Lead sponsor	Odense University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,401
Start date	3 June 2020
Primary completion	15 November 2022
Estimated completion	15 November 2022
Sites	1 location across Denmark

Drugs / interventions tested

• Geriatric 8
• modified Geriatric 8
• 30 second chair stand test
• Handgrip Strength Test

Conditions studied

• Solid Carcinoma — all drugs for Solid Carcinoma →
• Frailty — all drugs for Frailty →
• Age — all drugs for Age →
• Geriatrics — all drugs for Geriatrics →

Sponsor

Odense University Hospital

Who can join

70 and older, any sex, with Solid Carcinoma or Frailty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

* 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Association between Geriatric 8 frailty and overall survival, treatment intensity, and treatment tolerance in older patients with cancer (PROGNOSIS-G8).
   Ditzel HM, Giger AW, Lund CM, Ditzel HJ, et al · · 2026 · PMID 42208483 · DOI 10.1016/j.jgo.2026.103021