ラジオゲノミクスを使用した膵管内乳頭粘液性腫瘍の悪性度の予測
ラジオゲノミクスを使用して膵管内乳頭粘液性腫瘍 (IPMN) の悪性度を非侵襲的に予測し、隠された生物学を明らかにする
The Florida Pancreas Collaborative wants to partner with individuals who are known to have, or are suspected to have a pancreatic lesion, tumor, cyst, mass, cancer, or pancreatitis and are undergoing diagnosis and treatment at a participating institution. The goals of this project are to build a large database of information obtained from blood, tissue, medical images, surveys and information from routine care to develop noninvasive diagnostic approaches that could be used as decision-making tools to effectively personalize clinical care.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Florida
-
Lakewood Rch、Florida、アメリカ、34211
- Florida Research Institute (FRI)
-
Miami、Florida、アメリカ、33136
- Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
-
Tampa、Florida、アメリカ、33612
- Moffitt Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients of the GI clinic, surgery, or endoscopy at Moffitt Cancer Center, University of Florida - Gainesville, or the University of Miami - Jackson Memorial Hospital.
説明
Inclusion Criteria:
- Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, Florida Research Institute (FRI), or UM with a clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis based on symptoms, imaging, or blood-work and has not had any treatment involving their pancreas.
- Able to understand and voluntarily sign the informed consent.
- Willing to complete study questionnaire(s) and donate medical images and/or biological specimens (including blood, cystic fluid, and/or tissue) obtained at the time of standard of care procedures (biopsy, surgery, and venipuncture) after signing the informed consent document
Exclusion Criteria:
- No suspicion or diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis.
- Has a diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis and has already undergone treatment involving the pancreas (which may involve surgery, chemo- or immuno-therapy, and/or radiation).
- Unable to provide informed consent.
- Unwilling to complete study questionnaire(s) and/or donate biological specimens or images.
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
- 観測モデル：CASE_ONLY
- 時間の展望：OTHER
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Retrospective Cohort
Retrospective chart review of pathologically-confirmed Intraductal Papillary Mucinous Neoplasm (IPMN) cases |
|
|
Prospective Cohort
Blood, tumor tissue samples and data will be collected. |
Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date), 4-6 weeks post-surgery, if applicable, and at the time of follow-up (approximately 1 year and approximately 2 years after baseline). At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue, muscle, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected. Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups. |
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 |
|---|---|---|
|
Predictive value of CT Radiomic features vs conventional radiologic features
時間枠：Up to 2 years
|
Preoperative CT images will be evaluated for a retrospective cohort of at least 254 pathologically-confirmed IPMN cases (approximately 190 malignant characterized by high-grade dysplasia or invasion and approximately 64 benign characterized by low- or moderate-grade dysplasia). 3D-radiomic features will be extracted with the new Quantitative Imaging Decision Support (QIDS)™ platform (Healthmyne, Inc.) and associations will be evaluated with pathology. |
Up to 2 years
|
|
Development of Clinical Decision Making Models for Predicting IPMN Pathology
時間枠：Up to 2 years
|
Investigators will develop the first prototype preoperative 'omics'-based nomograms to predict IPMN pathology by integrating radiomic features, the MGC, and other covariates. Emphasis will be placed on developing nomograms for individuals whose IPMNs appear to have 'worrisome' radiologic features which are very challenging to manage. |
Up to 2 years
|
|
Radiogenomic Analyses
時間枠：Up to 2 years
|
Investigators will conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers. |
Up to 2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival
時間枠：Up to 4 years
|
Overall survival is defined as time from surgery to death from any cause. |
Up to 4 years
|
|
Progression Free Survival
時間枠：Up to 4 years
|
Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death. |
Up to 4 years
|
協力者と研究者
捜査官
- 主任研究者：Jennifer Permuth, PhD、Moffitt Cancer Center
出版物と役立つリンク
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
- MCC-20105
- 1R37CA229810-01A1 (米国 NIH グラント/契約)
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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