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Enrolling by invitationNCT06761534Updated May 15, 2025

Development and Verification of a Screening Tool for Comprehensive Geriatric Assessment of Elderly Tumor Patients

An observational study in Geriatric Assessment, Geriatric Patients and Patients With Cancer, sponsored by Sichuan Cancer Hospital and Research Institute. Enrolling by invitation at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Sichuan Cancer Hospital and Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
678
Ages
65 Years and older
Sex
All
01

Study summary

This study is an observational research.

  1. The study first conducted an electronic questionnaire survey among clinicians working in general and specialized hospitals at various levels nationwide to understand the implementation status and influencing factors of comprehensive geriatric assessment (CGA) for elderly cancer patients in China.
  2. Based on the survey results, an interview outline was developed, and semi-structured interviews were conducted with professional doctors experienced in the diagnosis and treatment of elderly cancer patients to further explore the comprehensive factors influencing the implementation of CGA for this population.
  3. According to the feedback from the semi-structured interviews, the survey results, and literature reports, the assessment dimensions required for the CGA screening tool were selected. An expert consultation survey questionnaire was designed around these dimensions, and the most suitable assessment items under each dimension were determined using the Delphi expert consultation method.
  4. The G8 scale was used to assess elderly cancer patients. Items were selected based on their performance to form the screening tool. By setting thresholds and allocating weights for each item, CGA Screening Tool 1.0 was developed.
  5. Pre-testing and modification of the screening tool were conducted. Investigators used the initially formed screening tool to conduct one-on-one patient testing. Feedback on the tool's clarity, relevance, clinical applicability (localization), and feasibility was obtained through consultation with a clinical expert panel to improve and refine its content and management process. This led to the revision and formation of CGA Screening Tool 2.0.
  6. The reliability and validity of the CGA screening tool were verified using classical measurement theory to ensure the stability, reliability, and effectiveness of the scale tool in practical applications.
  7. Patients were assessed using both CGA and the screening tool. External validation of Screening Tool 2.0 was performed using CGA as the gold standard to further evaluate the sensitivity, specificity, and accuracy of the screening tool.
  8. Patients who participated in the assessment during the study were followed up to compare the correlation between different assessment results and patient completion of anti-tumor treatment, treatment efficacy, and the risk of related adverse reactions. The impact of the CGA screening tool on the implementation of CGA and its predictive ability for anti-tumor treatment were explored. Study data were obtained from the electronic medical record database and hospital information system of Sichuan Cancer Hospital, including clinicopathological features such as gender, age, clinical stage at diagnosis, and information related to anti-tumor treatment.
02

Conditions studied

  • Geriatric Assessment
  • Geriatric Patients
  • Patients With Cancer
  • Assessment Tool
03

In context

Lead sponsor

Sichuan Cancer Hospital and Research Institute is the lead sponsor of 62 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Among all participants, 316 were used to develop the screening tool, 10 for the pre-testing, and 132 for the reliability and validity testing of the screening scale. After the scale was completed, the remaining 220 patients were used for the external validation of the tool. Finally, all patients evaluated using the screening tool were grouped according to different screening results, and the treatment effects and risks among the groups were compared.

Inclusion criteria

  1. Age ≥ 65 years old
  2. There are clear pathological data to diagnose malignant tumors, and follow-up anti-tumor therapy is determined in this institution
  3. Have a certain enthusiasm for this study, and voluntarily participate in this study

Exclusion criteria

Exclusion Criteria:

  1. Unable to understand the content of the research
  2. Unable to cooperate with CGA and screening assessments
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
678 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Elderly cancer patients

    Elderly cancer patients were assessed with the screening tool and G8. If the patient's screening result is positive (frailty risk population), continue with the CGA.

    Other: Screening of comprehensive geriatic assessment. · Other: the G8 assessment · Other: Comprehensive Geriatric Assessment (CGA)

Interventions

  • OtherScreening of comprehensive geriatic assessment.

    The participants are screened before anti-tumor therapy with a comprehensive assessment screening tool developed for elderly cancer patients, which is more suitable for individualized decision-making in anti-tumor treatment.

  • Otherthe G8 assessment

    The G8 is a rapid geriatric screening test that takes only a few minutes to complete. It is used as a calibration standard to validate the novel screening tool in this study.

  • OtherComprehensive Geriatric Assessment (CGA)

    The participants screened as a high frailty risk will undergo CGA to determine the most appropriate treatment plan.

06

What researchers measure

Primary outcomes

  1. Sensitivity

    (Truly frail elderly patients assessed by the novel screening tool and G8) / (Truly frail risk patients + elderly patients with negative results from novel screening tool but actually at risk of frailty after G8 assessment

    Time frame: Baseline

Secondary outcomes

  1. Accuracy

    (The number of elderly patients truly at risk of frailty assessed by the novel screening tool and G8 + the number of elderly patients truly without frailty risk) / Total number of elderly patients in the study

    Time frame: Baseline

  2. Specificity

    (True elderly patients without frailty risk assessed by the novel screening tool and G8) / (True patients without frailty risk + elderly patients with positive results from novel screening tool but actually without frailty risk after G8 screening)

    Time frame: Baseline

Other outcomes

  1. ORR

    the sum percentage of participants with CR and PR assessed by RECIST v1.1 criteria every 8-12 weeks.

    Time frame: From date receiving anti-tumor therapy after the first screening assessment until date of disease progression or the end of study, whichever came first, assessed up to 12 months.

  2. PFS

    Systemic Progression-Free Survival assessed by the investigators using RECIST V1.1.

    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.

  3. AE

    Number and percentage of patents with treatment-related adverse events assessed by CTCAE v5.0.

    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.

07

Study locations

1 site
  • Sichuan Cancer Hospital
    Chengdu, Sichuan 610000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06761534
Lead sponsor
Sichuan Cancer Hospital and Research Institute
Responsible party
Juan LI, MD (Director, Sichuan Cancer Hospital and Research Institute) — Principal investigator
First posted
Jan 7, 2025
Start date
Feb 5, 2025
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 15, 2025

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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