Molecular Profiling for Risk Stratification in Appendiceal Cancer
Molecular Profiling for Tumor Characterization and Risk Stratification in Patients With Appendiceal Cancer
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Ajay Goel
- Número de telefone: 6262184673
- E-mail: ajgoel@coh.org
Locais de estudo
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California
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Durate, California, Estados Unidos, 91016
- Recrutamento
- City of Hope Medical Center
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Contato:
- Ajay Goel, MD
- Número de telefone: 6262184673
- E-mail: ajgoel@coh.org
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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.
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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.
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall Survival
Prazo: Through study completion, an average of 1 year
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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
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Through study completion, an average of 1 year
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Progression-Free Survival
Prazo: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças Intestinais
- Neoplasias por Tipo Histológico
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Intestinais
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Carcinoma
- Neoplasias Císticas, Mucinosas e Serosas
- Neoplasias cecais
- Doenças cecais
- Adenocarcinoma Mucinoso
- Neoplasias do Apêndice
Outros números de identificação do estudo
- 23228_CIPHER-AC
Plano para dados de participantes individuais (IPD)
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