방사선유전체학을 사용하여 췌장의 관내 유두 점액 신생물의 악성 가능성 예측
방사선유전체학을 사용하여 췌장의 관내 유두 점액 종양(IPMN)의 악성 가능성을 비침습적으로 예측하고 숨겨진 생물학을 발견
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.
연구 개요
상태
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Florida
-
Lakewood Rch, Florida, 미국, 34211
- Florida Research Institute (FRI)
-
Miami, Florida, 미국, 33136
- Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
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Tampa, Florida, 미국, 33612
- Moffitt Cancer Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients of the GI clinic, surgery, or endoscopy at Moffitt Cancer Center, University of Florida - Gainesville, or the University of Miami - Jackson Memorial Hospital.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: OTHER
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Predictive value of CT Radiomic features vs conventional radiologic features
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival
기간: Up to 4 years
|
Overall survival is defined as time from surgery to death from any cause. |
Up to 4 years
|
|
Progression Free Survival
기간: Up to 4 years
|
Progression free survival is defined as time from surgery to either pancreatic cancer recurrence or death. |
Up to 4 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jennifer Permuth, PhD, Moffitt Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- MCC-20105
- 1R37CA229810-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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