Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil (CORALINE)
2026年8月24日 更新者：Latin American Cooperative Oncology Group
Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil - CORALINE (LACOG 0625)
This is a prospective observational cohort study including 250 individuals aged 70 years or older newly diagnosed with solid tumors. In this non-interventional study, all patient contacts will be conducted via telephone or video call.
After obtaining informed consent which will be conducted electronically, an initial telemedicine assessment will be performed. During this evaluation, sociodemographic and clinical data will be collected, and a Comprehensive Geriatric Assessment (CGA) will be conducted. The assessment will be performed by a trained professional using internationally recognized, validated instruments that are preferably culturally adapted to the Brazilian population. The G8 score will be calculated based on information collected at baseline. Additionally, medication use, the Charlson Comorbidity Index, Mini Nutritional Assessment, and self-rated health status will be recorded. The total G8 score ranges from 0 to 17, with higher scores indicating better health status (abnormal G8 score ≤14).
研究概览
详细说明
There will be no access to or review of medical records in this study; all information will be obtained directly from participants through telemedicine assessments and follow-up contacts.
Participants will continue to receive treatment and clinical evaluations as determined by their treating physicians, according to standard clinical practice.
No intervention is proposed in this study.
Participants will be contacted for follow-up at 3, 6, 12, 18, 24, and 36 months.
During follow-up, information regarding treatment continuation, treatment discontinuation due to toxicity, and survival status will be collected.
The primary endpoints are overall survival and early mortality, defined as death occurring within six months after study inclusion, as well as overall survival at 1 year and 3 years.
Following approval by the Research Ethics Committee, the study will be conducted in a decentralized manner, with recruitment occurring through spontaneous demand or referral by treating physicians from different institutions, preferably among investigators affiliated with LACOG who are aware of the study protocol.
研究类型
观察性的
注册 (估计的)
250
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Laura Voelcker
- 电话号码：+55 (51) 3384.5334
- 邮箱：laura.voelcker@lacog.group
研究联系人备份
- 姓名：Ayanie Ribeiro
- 电话号码：+55 (51) 3384.5334
- 邮箱：ayanie.ribeiro@lacog.group
学习地点
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São Paulo
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São Paulo、São Paulo、巴西、04004-030
- HCOR - Hospital do Coração
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接触：
- Luciola Barros
- 电话号码：+5511986740192
- 邮箱：luciolaplbarros@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population will consist of 250 individuals aged ≥70 years with a new diagnosis of solid tumors, enrolled from different regions of Brazil.
Eligible individuals will be identified and invited to participate after ethics committee approval and informed consent.
描述
Inclusion Criteria:
- Aged 70 or above
- Diagnosis of cancer (solid tumors)
- Metastatic or recurrent cancer (treatment-naïve) regardless of the interval from prior localized disease
- Intention to start first systemic line of therapy
- Be able to understand and provide informed consent (ICF).
Exclusion Criteria:
1. Nonmelanoma skin cancer
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Prospective Observational Cohort
individuals aged 70 years or older newly diagnosed with metastatic or recurrent solid tumors (treatment-naïve ) regardless of the interval from prior localized disease tradução
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sensitivity of the G8 screening tool for frailty
大体时间：Baseline
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Evaluation of the sensitivity of the Geriatric 8 (G8) tool as a screening instrument for frailty (defined by Comprehensive Geriatric Assessment/CGA) in older adults (+70 years) newly diagnosed with solid tumors.
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Baseline
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Early Mortality
大体时间：6 months
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Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis
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6 months
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Overall Survival at 12 and 36 months
大体时间：12 months and 36 months.
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Proportion of participants surviving at 12 months (1 year) and 36 months (3 years) following study inclusion, calculated from enrollment to death or censoring
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12 months and 36 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Operational Characteristics of the G8 Tool for Frailty
大体时间：Baseline
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Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of the G8 score as a screening tool for frailty compared to Comprehensive Geriatric Assessment (CGA).
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Baseline
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Predictive ability of the G8 score
大体时间：6 and 36 months
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Area under the receiver operating characteristic (ROC) curve (AUC) evaluating the capacity of the baseline G8 score to predict survival outcomes.
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6 and 36 months
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discrimination and calibration of a risk model
大体时间：up to 36 months
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Discrimination and calibration metrics of the survival model.
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up to 36 months
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Prevalence of Frailty Indicators
大体时间：Baseline
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Prevalence of specific frailty indicators, including nutritional status impairment, functional deficit, and cognitive decline.
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Baseline
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Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality
大体时间：Up to 6 months
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Association between frailty and early mortality with variables such as age, sex, tumor site, comorbidities, functional status
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Up to 6 months
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Regional disparities in G8 performance
大体时间：Up to 36 months
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To explore regional differences in frailty prevalence and survival outcomes within Brazil
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Up to 36 months
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Comparative analysis of G8 versus CGA
大体时间：Up to 36 months
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To compare the predictive accuracy of the G8 against the Comprehensive Geriatric Assessment (CGA) and specific geriatric syndromes.
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Up to 36 months
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Hospitalization rates within 6 months according to G8.
大体时间：Up to 6 months
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To explore the association between G8 scores and complications.
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Up to 6 months
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Overall Survival Stratified by G8 Classification
大体时间：6 months and 36 months
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Overall survival rates described and stratified according to G8 score classification (normal vs. abnormal score).
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6 months and 36 months
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Operational Characteristics of G8 for Survival
大体时间：6 months and 36 months.
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Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of the G8 tool to predict mortality.
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6 months and 36 months.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ludmila Koch、Hospital israelita Albert Einstein
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年11月1日
研究完成 (估计的)
2030年9月1日
研究注册日期
首次提交
2026年8月12日
首先提交符合 QC 标准的
2026年8月12日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月26日
上次提交的符合 QC 标准的更新
2026年8月24日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- LACOG 0625
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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