Molecular Profiling for Risk Stratification in Appendiceal Cancer
Molecular Profiling for Tumor Characterization and Risk Stratification in Patients With Appendiceal Cancer
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Ajay Goel
- 电话号码：6262184673
- 邮箱：ajgoel@coh.org
学习地点
-
-
California
-
Durate、California、美国、91016
- 招聘中
- City of Hope Medical Center
-
接触：
- Ajay Goel, MD
- 电话号码：6262184673
- 邮箱：ajgoel@coh.org
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：Through study completion, an average of 1 year
|
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
|
Through study completion, an average of 1 year
|
|
Progression-Free Survival
大体时间：Through study completion, an average of 1 year
|
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.
|
Through study completion, an average of 1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 23228_CIPHER-AC
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.