An observational study in Appendiceal Cancer and Appendiceal Adenocarcinoma, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by City of Hope Medical Center · Observational
This study investigates integrated epigenetic and epitranscriptomic features of appendiceal cancer using archived tumor tissue specimens from the same patient cohort. The study includes DNA methylation profiling and m6A epitranscriptomic profiling to define molecular subtypes, evaluate associations with clinicopathologic features, and develop molecular risk scores for prognostic stratification. The primary goal is to determine whether DNA methylation- and m6A-based molecular features can complement conventional histopathologic grading and improve risk stratification.
Appendiceal cancer is a rare and heterogeneous malignancy with limited clinically actionable biomarkers for risk stratification. Histologic grade remains one of the strongest determinants of prognosis, but outcomes among patients with lower-grade disease remain variable. This study is designed to characterize the molecular architecture of appendiceal cancer through integrated analysis of DNA methylation and m6A epitranscriptomic profiles generated from archived tumor tissue specimens from the same patient cohort.
The study uses formalin-fixed paraffin-embedded appendiceal cancer tissues, and where available benign or normal appendix tissues, together with matched clinicopathologic and follow-up data. DNA methylation profiling is performed to evaluate tumor-associated methylation patterns, identify differentially methylated regions or features, and assess their association with clinical and survival outcomes. In parallel, m6A epitranscriptomic profiling is performed using m6A-enriched RNA sequencing with matched input RNA sequencing to quantify transcriptome-wide m6A enrichment.
Molecular data are analyzed to identify tumor-associated epigenetic and epitranscriptomic alterations, define molecular subtypes, and construct continuous molecular risk scores. These molecular features are evaluated in relation to histologic grade, histologic subtype, lymph node metastasis, lymphovascular invasion, perineural invasion, peritoneal cancer index, overall survival, and progression-free survival.
The study aims to determine whether DNA methylation and m6A-based profiling can provide complementary molecular information for appendiceal cancer classification, prognostic modeling, and future biomarker development.
55 studies on the registry are indexed under Appendiceal Neoplasms; 23 are open to participants now.
This study's planned enrollment of 400 is close to the median of 400 across 15 observational studies indexed under Appendiceal Neoplasms.
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The study population includes adult patients with appendiceal cancer whose archived tumor specimens and associated clinicopathologic data are available for retrospective molecular profiling. The same patient cohort is used for DNA methylation and m6A epitranscriptomic analyses where sufficient biospecimen material is available. Benign or normal appendix tissue specimens may be included as non-malignant reference controls.
Exclusion Criteria:
Patients with histologically confirmed appendiceal cancer whose archived tumor tissue specimens and clinicopathologic data are available for integrated DNA methylation and m6A epitranscriptomic profiling.
Diagnostic Test: DNA Methylation Profiling · Diagnostic Test: m6A Epitranscriptomic Profiling
Individuals with benign or normal appendix tissue specimens used as non-malignant reference samples for comparison of tumor-associated DNA methylation and m6A epitranscriptomic features.
Diagnostic Test: DNA Methylation Profiling · Diagnostic Test: m6A Epitranscriptomic Profiling
Archived tissue specimens undergo DNA methylation profiling to characterize tumor-associated methylation alterations and identify methylation-based molecular features associated with clinicopathologic variables and survival outcomes. The profiling is performed for research purposes only and does not assign treatment.
Archived tissue specimens undergo m6A methylated RNA immunoprecipitation sequencing with matched input RNA sequencing to quantify transcriptome-wide m6A enrichment. The resulting molecular data are used for subtype discovery, m6A score construction, reduced-panel development, and association with clinicopathologic and survival outcomes.
Overall Survival
Overall survival will be evaluated in relation to molecular profiling results and available clinicopathologic characteristics. Survival analyses may include Kaplan-Meier analysis and Cox proportional hazards models
Time frame: Through study completion, an average of 1 year
Progression-Free Survival
Progression-free survival will be evaluated in relation to molecular profiling results and available clinicopathologic characteristics. Time-to-event analyses may be performed using standard survival analysis methods.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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