Clinical trial · Observational
Geriatric Oncology Screening of Older Patients With Solid Cancers
Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers: A Prospective G8 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Age | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Frailty | — | UNRESOLVED | — |
| Geriatrics | — | UNRESOLVED | — |
| Screening | — | UNRESOLVED | — |
| Solid Carcinoma | Solid Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 30 second chair stand test | Diagnostic Test | — | UNRESOLVED |
| Geriatric 8 | Diagnostic Test | — | UNRESOLVED |
| Handgrip Strength Test | Diagnostic Test | — | UNRESOLVED |
| modified Geriatric 8 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Older cancer patients
- description
- All 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,
- interventionNames
- Diagnostic Test: Geriatric 8
- Diagnostic Test: modified Geriatric 8
- Diagnostic Test: 30 second chair stand test
- Diagnostic Test: Handgrip Strength Test
Primary outcomes (1)
- measure
- Global health status / Quality of Life
- timeFrame
- 12 months
- description
- Global health status will be described using EORTC QLQ-C30
Secondary outcomes (8)
- measure
- Health-related Quality of Life (HRQoL)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (2)
- DERIVEDDitzel 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. PMID 42208483
- DERIVEDDitzel 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. PMID 34176752