Diagnostic Utility of Serum CEA and Ca 19.9 as Triage Tools for Predicting Metastatic Disease in Gallbladder Cancer: A Sub-analysis from a Prospective Observational Study.
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Abstract
Purpose: Gallbladder cancer is a highly aggressive malignancy with disproportionate incidence in the Gangetic belt of India. Early diagnosis is critical yet most patients present with advanced-stage disease. Serum tumor markers like CEA and Ca 19.9 are often elevated in gallbladder cancer, but their role in rapidly triaging patients for metastatic disease at presentation has not been prospectively validated in prospective cohort.
Methods: This sub-analysis is part of a larger prospective observational study conducted at a tertiary cancer center in North India. A total of 1500 newly diagnosed, treatment-naïve or incidental gallbladder cancer patients were enrolled between September 2023 and May 2024. Serum CEA and Ca 19.9 levels were measured at baseline. Diagnostic thresholds were derived using the 75th percentile values stratified by obstructive jaundice status. Diagnostic accuracy for predicting metastatic disease was assessed using confusion matrices, ROC curves, and precision-recall analysis.
Results: Of 1500 patients, 1203 (80.2%) presented with metastatic disease. Serum data were available for 1011 patients. Patients with metastatic disease had significantly higher marker levels (CEA: mean 288.4 vs. 22.9 ng/mL; Ca 19.9: 20,917 vs. 2241 U/mL). The model showed high specificity (89.1%) and positive predictive value (92.3%) with moderate AUC (0.74). Sensitivity was limited (40.3%), suggesting strong "rule-in" but weak "rule-out" capability.
Conclusions: Elevated serum CEA and Ca 19.9 adjusted for jaundice status are strong indicators of metastatic gallbladder cancer at presentation. This real-world percentile-based approach offers a rapid, low-cost diagnostic adjunct for early triage in resource-limited settings. The findings provide context-sensitive thresholds that may aid timely treatment decisions in high-burden regions.
期刊介绍：
The Journal of Gastrointestinal Cancer is a multidisciplinary medium for the publication of novel research pertaining to cancers arising from the gastrointestinal tract.The journal is dedicated to the most rapid publication possible.The journal publishes papers in all relevant fields, emphasizing those studies that are helpful in understanding and treating cancers affecting the esophagus, stomach, liver, gallbladder and biliary tree, pancreas, small bowel, large bowel, rectum, and anus. In addition, the Journal of Gastrointestinal Cancer publishes basic and translational scientific information from studies providing insight into the etiology and progression of cancers affecting these organs. New insights are provided from diverse areas of research such as studies exploring pre-neoplastic states, risk factors, epidemiology, genetics, preclinical therapeutics, surgery, radiation therapy, novel medical therapeutics, clinical trials, and outcome studies.In addition to reports of original clinical and experimental studies, the journal also publishes: case reports, state-of-the-art reviews on topics of immediate interest or importance; invited articles analyzing particular areas of pancreatic research and knowledge; perspectives in which critical evaluation and conflicting opinions about current topics may be expressed; meeting highlights that summarize important points presented at recent meetings; abstracts of symposia and conferences; book reviews; hypotheses; Letters to the Editors; and other items of special interest, including:Complex Cases in GI Oncology: This is a new initiative to provide a forum to review and discuss the history and management of complex and involved gastrointestinal oncology cases. The format will be similar to a teaching case conference where a case vignette is presented and is followed by a series of questions and discussion points. A brief reference list supporting the points made in discussion would be expected.
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