An observational study in Solid Tumor, Metastatic Solid Tumor and Recurrent Solid Tumor, sponsored by Latin American Cooperative Oncology Group. Not yet recruiting at 1 site in Brazil. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Latin American Cooperative Oncology Group · Observational
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).
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.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 250 is above the median of 136 across 557 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Latin American Cooperative Oncology Group is the lead sponsor of 48 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Nonmelanoma skin cancer
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Sensitivity of the G8 screening tool for frailty
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.
Time frame: Baseline
Early Mortality
Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis
Time frame: 6 months
Overall Survival at 12 and 36 months
Proportion of participants surviving at 12 months (1 year) and 36 months (3 years) following study inclusion, calculated from enrollment to death or censoring
Time frame: 12 months and 36 months.
Operational Characteristics of the G8 Tool for Frailty
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).
Time frame: Baseline
Overall Survival Stratified by G8 Classification
Overall survival rates described and stratified according to G8 score classification (normal vs. abnormal score).
Time frame: 6 months and 36 months
Predictive ability of the G8 score
Area under the receiver operating characteristic (ROC) curve (AUC) evaluating the capacity of the baseline G8 score to predict survival outcomes.
Time frame: 6 and 36 months
discrimination and calibration of a risk model
Discrimination and calibration metrics of the survival model.
Time frame: up to 36 months
Prevalence of Frailty Indicators
Prevalence of specific frailty indicators, including nutritional status impairment, functional deficit, and cognitive decline.
Time frame: Baseline
Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality
Association between frailty and early mortality with variables such as age, sex, tumor site, comorbidities, functional status
Time frame: Up to 6 months
Regional disparities in G8 performance
To explore regional differences in frailty prevalence and survival outcomes within Brazil
Time frame: Up to 36 months
Comparative analysis of G8 versus CGA
To compare the predictive accuracy of the G8 against the Comprehensive Geriatric Assessment (CGA) and specific geriatric syndromes.
Time frame: Up to 36 months
Hospitalization rates within 6 months according to G8.
To explore the association between G8 scores and complications.
Time frame: Up to 6 months
Operational Characteristics of G8 for Survival
Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of the G8 tool to predict mortality.
Time frame: 6 months and 36 months.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Latin American Cooperative Oncology Group