Molecular Profiling for Risk Stratification in Appendiceal Cancer
Molecular Profiling for Tumor Characterization and Risk Stratification in Patients With Appendiceal Cancer
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ajay Goel
- 電話番号：6262184673
- メール：ajgoel@coh.org
研究場所
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California
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Durate、California、アメリカ、91016
- 募集
- City of Hope Medical Center
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コンタクト：
- Ajay Goel, MD
- 電話番号：6262184673
- メール：ajgoel@coh.org
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Survival
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 23228_CIPHER-AC
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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