Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 770
- 试验地点
- 769
- 主要终点
- Occurrence of an "unfavorable" outcome
研究概览
简要总结
The purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer. The study doctors want to learn which monitoring method and which biomarkers lead to better outcomes for patients.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate whether the protocol specified primary biomarkers (both blood and imaging-based) measured at baseline, are associated with the future development of worrisome features and/or high-risk stigmata.
SECONDARY OBJECTIVES:
I. Evaluate whether the imaging-based secondary biomarker implemented using baseline computed tomography (CT) scans and/or the blood-based secondary biomarker panel, is associated with the future development of worrisome features and/or high-risk stigmata.
II. Estimate area under curve (AUC), sensitivity, specificity, negative, and positive predictive value of each biomarker.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be ≥ 50 years and ≤ 75 years of age
- •Patient must not have acute pancreatitis or a history of chronic pancreatitis
- •Patient must have received a CT, MRI, or EUS within 6 months prior to enrollment that revealed one or more ≥ 1 cm pancreatic cyst(s).
- •Patients of childbearing potential must not be known to be pregnant
- •Patient must not have a prior diagnosis of pancreatic malignancy of any type
- •Patient must not have a history of pancreatic resection
- •Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible
- •Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children)
- •Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥ 10mm, cyst causing obstructive jaundice)
- •Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection
- •Patient must not be in any form of pancreatic cyst surveillance for > 1 year, defined as organized, periodic up-to-date imaging directed towards the pancreatic cyst of interest
- •PRIOR TO ADDENDUM #5 08/13/2024: Patient must be ≥ 50 years and ≤ 75 years of age
- •PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have acute pancreatitis or a history of chronic pancreatitis.
- •PRIOR TO ADDENDUM #5 08/13/2024: Patient must have received a CT, MRI, or EUS within 6 months prior to randomization that revealed one or more ≥ 1 cm pancreatic cyst (s).
- •PRIOR TO ADDENDUM #5 08/13/2024: Patients of childbearing potential must not be known to be pregnant.
- •PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a prior diagnosis of pancreatic malignancy of any type.
- •PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a history of pancreatic resection.
- •PRIOR TO ADDENDUM #5 08/13/2024: Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible.
- •PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children).
- •PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥10mm, cyst causing obstructive jaundice).
- •PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection.
排除标准
- 未提供
研究组 & 干预措施
Arm B (high intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with >= 2 and < 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst >= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Questionnaire Administration (Other)
Arm B (high intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with >= 2 and < 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst >= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Magnetic Resonance Imaging (Procedure)
Arm B (high intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with >= 2 and < 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst >= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Quality-of-Life Assessment (Other)
Arm B (high intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with >= 2 and < 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst >= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Biospecimen Collection (Procedure)
Arm A (low intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Biopsy Procedure (Procedure)
Arm A (low intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Endoscopic Ultrasound (Procedure)
Arm A (low intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (Procedure)
Arm A (low intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Magnetic Resonance Imaging (Procedure)
Arm A (low intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Questionnaire Administration (Other)
Arm B (high intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with >= 2 and < 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst >= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Biopsy Procedure (Procedure)
Arm B (high intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with >= 2 and < 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst >= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Computed Tomography (Procedure)
Arm B (high intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with >= 2 and < 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst >= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Endoscopic Ultrasound (Procedure)
Arm A (low intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Quality-of-Life Assessment (Other)
Observational
Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated.
干预措施: Biopsy Procedure (Procedure)
Observational
Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated.
干预措施: Surgical Procedure (Procedure)
Arm B (high intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with >= 2 and < 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst >= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (Procedure)
Observational
Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated.
干预措施: Biospecimen Collection (Procedure)
Observational
Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated.
干预措施: Computed Tomography (Procedure)
Observational
Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated.
干预措施: Endoscopic Ultrasound (Procedure)
Observational
Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated.
干预措施: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (Procedure)
Observational
Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm A (low intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Biospecimen Collection (Procedure)
Arm A (low intensity surveillance)
Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
干预措施: Computed Tomography (Procedure)
结局指标
主要结局
Occurrence of an "unfavorable" outcome
时间窗: Up to 5 years
Defined as a composite of: (1) any pancreatic cancer without surgery; (2) unresectable pancreatic cancer or cancer \> T1a, N0 at surgery, and (3) benign disease at surgery will be approached from the intent-to-treat perspective. Time to the first occurrence of the primary endpoint will measured from randomization. Survival analysis methods will be used to estimate and compare distributions of time to an unfavorable event between the study arms. In particular Kaplan-Meier estimates will be developed for each arm and a log rank test will be used to compare the two arms.
次要结局
- Rates of non-adherence(Up to 5 years)
- Major surgical morbidity(Up to 5 years)
- Surgical and all-cause mortality(Up to 5 years)
- Healthcare utilization of imaging, invasive testing, surgical, and other procedures using information collected from sites.(Up to 5 years)
- Biomarker analysis from collected samples to compare the predictive performance of known and future biomarkers for dysplasia or cancer(Up to 5 years)
- Patient reports of quality of life(Up to 5 years)
- Patient reports of situational anxiety(Up to 5 years)
- Pancreatic cancer incidence(Up to 5 years)
- Patient (out-of-pocket and other indirect) costs collected from patient surveys(Up to 5 years)
- Patient report of financial distress collected through patient surveys(Up to 5 years)