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

NCT06939764 | Not Yet Recruiting

• 1 other identifier: EK2025-SG8
• Study Type: observational
• Target: 346
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Solid Cancers; Geriatric Assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• TRAE

  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

  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

• PFS

  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 Outcomes (1)

• OS

  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

Interventions

Geriatric Screening using the sG8 scale OTHER

Geriatric screening using the sG8 scale

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who are unwilling to cooperate in completing the sG8 scale assessment.
• Patients who do not understand the content of this study or are unwilling to participate.

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: May 16, 2025
• Primary Completion: December 25, 2025
• Study Completion: April 30, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04