Application of the sG8 Scale in Real-World Geriatric Oncology Patients

This study is a multicenter, prospective, observational study. The study included patients aged 65 and older with solid tumors requiring systemic anti-tumor therapy. All patients underwent screening using the sG8 scale before the start of treatment, followed by routine treatment based on a plan developed through clinician decision-making. The study did not intervene in any way with the patients' diagnosis and treatment, and relevant clinical data during the treatment process were recorded accurately for follow-up patients. Study data were obtained from the electronic medical record databases and hospital information systems of multiple centers, including Sichuan Cancer Hospital. Patient clinicopathological features, pathological diagnoses, clinical stages, previous treatment histories, as well as anti-tumor treatment regimens after patient enrollment, drug dosages per cycle, treatment start times, incidence and grades of adverse events (AEs), and tumor response were extracted and collected from the medical records. All data were entered, managed, quality-controlled, exported, and analyzed through a real-world data management platform (RWDMP).

Study Overview

• Status: Not yet recruiting
• Conditions: Geriatric Assessment; Solid Cancers
• Intervention / Treatment: Other: Geriatric Screening using the sG8 scale

• Study Type: Observational
• Enrollment (Estimated): 346

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed pathological evidence of malignant solid tumors, requiring systemic anti-tumor therapy, and aged 65 years or older.

Description

Inclusion Criteria:

1. Patients aged 65 years or older.
2. Patients with confirmed malignant tumors based on definitive pathological data.
3. Patients who are assessed by clinicians to have indications for systemic anti-tumor therapy.
4. Patients with a survival time greater than 12 weeks.

Exclusion Criteria:

1. Patients who do not meet the above inclusion criteria or are considered unsuitable for this study by the investigator due to other circumstances.
2. Patients who are unwilling to cooperate in completing the sG8 scale assessment.
3. Patients who do not understand the content of this study or are unwilling to participate.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of unplanned treatment delays and treatment interruptions	The incidence of unplanned treatment delays and treatment interruptions	From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Systemic Progression-Free Survival assessed by the investigators using RECIST V1.1.	From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months.
TRAE	Number and percentage of patents with treatment-related adverse events assessed by CTCAE v5.0.	From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months
ORR	the sum percentage of participants with CR and PR assessed by RECIST v1.1 criteria every 8-12 weeks.	From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or death or the end of study, whichever came first, assessed up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall survival	From date receiving anti-tumor therapy after the first screening assessment until date of death or the end of study, whichever came first, assessed up to 12 months

Collaborators and Investigators

• Sponsor: Sichuan Cancer Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): May 16, 2025
• Primary Completion (Estimated): December 25, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: EK2025-SG8

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No