Solid TumorCORALINENCT07773285
Validation of the G8 Screening Tool for Prognostic Assessment of Frailty and Early Mortality in Elderly Individuals With Cancer: Prospective Cohort Study in Brazil
An observational study of Solid Tumor and Metastatic Solid Tumor, run by Latin American Cooperative Oncology Group at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Solid Tumor, Metastatic Solid Tumor, Recurrent Solid Tumor
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2026to Sep 2030
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 1. Nonmelanoma skin cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
HCOR - Hospital do Coração
São Paulo, São Paulo, 04004-030
Luciola Barros, +5511986740192, luciolaplbarros@gmail.com
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Solid Tumor, Metastatic Solid Tumor, Recurrent Solid Tumor
- Keywords
- Metastatic or recurrent cancer
- Medical subject headings
- Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Early Mortality
Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis
Measured: 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
Measured: 12 months and 36 months.
Secondary outcomes (10)
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).
Measured: Baseline
Overall Survival Stratified by G8 Classification
Overall survival rates described and stratified according to G8 score classification (normal vs. abnormal score).
Measured: 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.
Measured: 6 and 36 months
discrimination and calibration of a risk model
Discrimination and calibration metrics of the survival model.
Measured: up to 36 months
Prevalence of Frailty Indicators
Prevalence of specific frailty indicators, including nutritional status impairment, functional deficit, and cognitive decline.
Measured: 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
Measured: Up to 6 months
Regional disparities in G8 performance
To explore regional differences in frailty prevalence and survival outcomes within Brazil
Measured: 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.
Measured: Up to 36 months
Hospitalization rates within 6 months according to G8.
To explore the association between G8 scores and complications.
Measured: 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.
Measured: 6 months and 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludmila Koch, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773285
- Sponsor's protocol ID
- LACOG 0625
- Acronym
- CORALINE
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07773285
- Acronym / sponsor ID
- CORALINE / LACOG 0625
- Conditions
- Solid Tumor, Metastatic Solid Tumor, Recurrent Solid Tumor
- Keywords
- Metastatic or recurrent cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 19 Aug 2026 (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 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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- 1. Nonmelanoma skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of the G8 screening tool for frailty
Time frame: Baseline
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.
Early Mortality
Time frame: 6 months
Proportion of participants who die within 6 months (180 days) of study enrollment/diagnosis
Overall Survival at 12 and 36 months
Time frame: 12 months 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
10 secondary outcomes
Operational Characteristics of the G8 Tool for Frailty
Time frame: Baseline
Overall Survival Stratified by G8 Classification
Time frame: 6 months and 36 months
Predictive ability of the G8 score
Time frame: 6 and 36 months
discrimination and calibration of a risk model
Time frame: up to 36 months
Prevalence of Frailty Indicators
Time frame: Baseline
Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality
Time frame: Up to 6 months
Regional disparities in G8 performance
Time frame: Up to 36 months
Comparative analysis of G8 versus CGA
Time frame: Up to 36 months
Hospitalization rates within 6 months according to G8.
Time frame: Up to 6 months
Operational Characteristics of G8 for Survival
Time frame: 6 months and 36 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 26 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Ludmila Koch principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Metastatic Solid Tumor, run by Latin American Cooperative Oncology Group at 1 site in Brazil.
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 5 inclusion and 1 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Ayanie Ribeiro (+55 (51) 3384.5334, ayanie.ribeiro@lacog.group), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the G8 screening tool for frailty (time frame: Baseline). The study lists 3 primary outcomes in all. 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 26 Aug 2026.