Clinical trial NCT06939764: Application of the sG8 Scale in Real-World Geriatric Oncology Patients
Official title: Application of the sG8 Scale in Real-World Geriatric Oncology Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Solid Cancers
Geriatric Assessment
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 346
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of unplanned treatment delays and treatment interruptions
timeFrame: 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:
measure: TRAE
timeFrame: 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
measure: ORR
timeFrame: 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
measure: PFS
timeFrame: 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:
measure: OS
timeFrame: 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
Locations:
Study officials:
References: