Molecular Profiling for Risk Stratification in Appendiceal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically confirmed appendiceal adenocarcinoma or appendiceal cancer.
Availability of archived tumor tissue suitable for molecular profiling.
Availability of tissue for DNA methylation profiling, m6A epitranscriptomic profiling, or both.
Availability of relevant clinicopathologic data.
Disqualifiers
Insufficient tissue quantity or quality for molecular profiling.
Inadequate DNA or RNA quality for sequencing or molecular assay preparation.
Missing essential clinicopathologic information required for analysis.
Non-appendiceal primary tumor or metastatic tumor to the appendix from another primary site.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
DNA Methylation Profiling
Diagnostic testArchived 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.
m6A Epitranscriptomic Profiling
Diagnostic testArchived 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Appendiceal Cancer Cohort2 interventions
Group B: Benign Appendix Reference Cohort2 interventions
Trial outcomes
Primary outcomes
1
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 year2
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 yearLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
City of Hope Medical CenterRecruiting91016, Durate, California
United States
United StatesSponsors and contacts
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Source ClinicalTrials.gov