Solid CancersNCT06939764
Application of the sG8 Scale in Real-World Geriatric Oncology Patients
An observational study of Solid Cancers and Geriatric Assessment, run by Sichuan Cancer Hospital and Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Solid Cancers, Geriatric Assessment
- What is being tested?
- Geriatric Screening using the sG8 scale
- How many people
- 346 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with confirmed pathological evidence of malignant solid tumors, requiring systemic anti-tumor therapy, and aged 65 years or older.
Who may be able to join
- 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.
Who cannot join
- Patients who do not meet the above inclusion criteria or are considered unsuitable for this study by the investigator due to other circumstances.
- 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.
About this study
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
- Being tested
- Geriatric Screening using the sG8 scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Screening using the sG8 scaleOther
Geriatric screening using the sG8 scale
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of unplanned treatment delays and treatment interruptions
The incidence of unplanned treatment delays and treatment interruptions
Measured: 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
Number and percentage of patents with treatment-related adverse events assessed by CTCAE v5.0.
Measured: 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.
Measured: 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
Systemic Progression-Free Survival assessed by the investigators using RECIST V1.1.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start16 May 2025 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan LI, MD, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939764
- Sponsor's protocol ID
- EK2025-SG8
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the sG8 Scale in Real-World Geriatric Oncology Patients
- ClinicalTrials.gov ID
- NCT06939764
- Acronym / sponsor ID
- EK2025-SG8
- Conditions
- Solid Cancers, Geriatric Assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 16 May 2025 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with confirmed pathological evidence of malignant solid tumors, requiring systemic anti-tumor therapy, and aged 65 years or older.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who do not meet the above inclusion criteria or are considered unsuitable for this study by the investigator due to other circumstances.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric Screening using the sG8 scaleGeriatric screening using the sG8 scale | Other | – |
Primary outcome
The incidence of unplanned treatment delays and treatment interruptions
Time frame: 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
The incidence of unplanned treatment delays and treatment interruptions
3 secondary outcomes
TRAE
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Cancers and Geriatric Assessment, run by Sichuan Cancer Hospital and Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of unplanned treatment delays and treatment interruptions (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.