Recruiting

Epigenetic Profiling

Sponsor:

City of Hope Medical Center

Code:

NCT07587268

Conditions

Appendiceal Cancer

Appendiceal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DNA Methylation Profiling

m6A Epitranscriptomic Profiling

Study Details

Brief summary:

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.

Conditions

Appendiceal Cancer

Appendiceal Adenocarcinoma

Study ID

NCT07587268

Start date

May 1, 2026

Status verified date

Jun, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Availability of survival or follow-up information when applicable.
  • Age 18 years or older at diagnosis or tissue collection.

Exclusion Criteria:

  • 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.
  • Patients who do not meet institutional review board or consent requirements, if applicable.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Appendiceal Cancer Cohort

Patients with histologically confirmed appendiceal cancer whose archived tumor tissue specimens and clinicopathologic data are available for integrated DNA methylation and m6A epitranscriptomic profiling.

Benign Appendix Reference Cohort

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.

Interventions

DNA Methylation 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.

m6A Epitranscriptomic Profiling

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.

Primary outcome measure

  • Overall Survival [ Time Frame: Through study completion, an average of 1 year ]
  • Progression-Free Survival [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Ajay Goel

6262184673ajgoel@coh.org

Locations

City of Hope Medical Center

Recruiting

Durate, California, United States, 91016

Contacts

Ajay Goel, MD

6262184673ajgoel@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Appendiceal cancer
  • Appendiceal adenocarcinoma
  • DNA methylation
  • m6A modification
  • Multi-omics
  • MeRIP-seq
  • Histologic grade;
  • Epigenomics
  • Epitranscriptomics
  • Molecular subtype
  • Risk stratification
  • Prognostic biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-06-29.