{"type":"trials","record":{"id":34599,"source_id":"clinicaltrials-gov","external_id":"NCT07773285","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","brief_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. 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).","overall_status":"Not Yet Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Latin American Cooperative Oncology Group","enrollment":250,"countries":["Brazil"],"start_date":"2026-09-01","completion_date":"2030-09-01","last_update_date":"2026-08-26","source_url":"https://clinicaltrials.gov/study/NCT07773285","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"CORALINE","age_range":"70 Years","comparator":null,"organization":"Latin American Cooperative Oncology Group","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Sensitivity of the G8 screening tool for frailty — Baseline","Early Mortality — 6 months","Overall Survival at 12 and 36 months — 12 months and 36 months.","Operational Characteristics of the G8 Tool for Frailty — Baseline","Overall Survival Stratified by G8 Classification — 6 months and 36 months","Predictive ability of the G8 score — 6 and 36 months","discrimination and calibration of a risk model — up to 36 months","Prevalence of Frailty Indicators — Baseline","Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality — Up to 6 months","Regional disparities in G8 performance — Up to 36 months","Comparative analysis of G8 versus CGA — Up to 36 months","Hospitalization rates within 6 months according to G8. — Up to 6 months","Operational Characteristics of G8 for Survival — 6 months and 36 months."],"design_description":null,"source_has_results":false},"controlled_terms":["Solid Tumor","Metastatic Solid Tumor","Recurrent Solid Tumor"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: cancer.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07773285","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-09-01 to 2030-09-01","comparator":null,"confidence":"structured-source","population":"ALL · 70 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.395Z","intervention":[],"participants":250,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Sensitivity of the G8 screening tool for frailty — Baseline","Early Mortality — 6 months","Overall Survival at 12 and 36 months — 12 months and 36 months.","Operational Characteristics of the G8 Tool for Frailty — Baseline","Overall Survival Stratified by G8 Classification — 6 months and 36 months","Predictive ability of the G8 score — 6 and 36 months","discrimination and calibration of a risk model — up to 36 months","Prevalence of Frailty Indicators — Baseline","Sociodemographic and Clinical Factors Associated With Frailty and Early Mortality — Up to 6 months","Regional disparities in G8 performance — Up to 36 months","Comparative analysis of G8 versus CGA — Up to 36 months","Hospitalization rates within 6 months according to G8. — Up to 6 months","Operational Characteristics of G8 for Survival — 6 months and 36 months."],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"cancer-and-aging","is_published":true,"match_reasons":["Title contains controlled term: cancer.","Abstract contains controlled term: tumor.","Source terminology contains: tumor.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Cancer and ageing","slug":"cancer-and-aging"}},{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/34599","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}