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The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.
In this research study, investigators will combine blood-based tests and review of symptoms with standard-of-care pancreatic cancer screening procedures to see if pancreatic cancer can be detected early among individuals with increased risk. Pancreatic cancer screening procedures include Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI), or Magnetic Resonance Cholangiopancreatography (MRCP).
The research study procedures include screening for eligibility, questionnaires, clinic visits, endoscopic ultrasound (EUS) or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples.
Participation in this research study will be a minimum of 30 months and up to 20 years via review of medical records and the annual collection of blood and stool samples.
It is expected that about 5,000 people will take part in this research study.
This study is supported by the Hale Family Research Center at Dana-Farber Cancer Institute.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic Cancer High-Risk Participants | Experimental | Study procedures will be conducted as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening Blood Tests | Other | Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms | Subjects will be counted in this metric if they have pathological tissue confirmation of a pancreatic cancer or high-grade dysplasia during each observation period. | 6-monthly for 3 years with 5-year follow-up |
| Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms | Subjects will be considered imaging-positive if they have a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia that was initially detected on standard-of-care screening MRI or EUS during each observation period. | 6-monthly for 3 years with 5-year follow-up |
| Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms | Subjects will be considered imaging-negative and assay-positive if: 1) the subject has a study visit that yields any newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3 with negative MRI and/or EUS at that visit or within six months prior to that visit; and 2) has a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia within two years after that visit. | 6-monthly for 3 years with 5-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value of Blood Assays | Positive predictive value of blood assays, defined as newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3, with a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a positive blood assay. | 6-monthly for 3 years |
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Inclusion Criteria:
Participants must meet any of the following:
Individuals with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years.
Individuals with pathogenic/likely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).
Individuals with pathogenic/likely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND
• Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic/likely pathogenic germline variant.
Individuals with pathogenic/likely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).
Individuals with familial pancreatic cancer including:
Individuals who are undergoing clinically recommended pancreatic cancer surveillance.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Yurgelun, MD | Contact | 617-582-8673 | matthew_yurgelun@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Yurgelun, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Matthew Yurgelun, Matthew_Yurgelun@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| Endoscopic Ultrasound | Diagnostic Test | Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. |
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| Magnetic Resonance Imaging | Combination Product | Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. |
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| Magnetic Resonance Cholangiopancreatography | Combination Product | Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. |
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| Negative Predictive Value of Blood Assays | Negative predictive value of blood assays, defined as CA19-9 (<=35U/mL or <20% increase) or diabetes (FBG <100mg/dL for first time or HgbA1c increased by less than 0.5) assay result or ENDPAC score <3, without a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a negative blood assay. | 6-monthly for 3 years |
| Proportion of Screen-Detected, Resected Pancreatic Lesions | Number of screen-detected pancreatic lesions that are resected compared to the total number of screen-detected pancreatic lesions. | 6-monthly for 3 years |
| Proportion of Non-Worrisome Pancreatic Lesions | Number of pancreatic lesions that are biopsied without cancer or high-grade dysplasia divided by number of pancreatic lesions that are biopsied. | 6-monthly for 3 years |
| Incremental Yield of Blood-Based Assays over Standard-of-Care Screening | Number of imaging-negative, assay-positive cases showing cancer or high-grade dysplasia divided by the total number of imaging-negative cases with cancer or high-grade dysplasia. | 6-monthly for 3 years |
| Number of False-Positive Assay Results | Number of positive assay results, defined as newly positive CA19-9 (>35U/mL or >=20% increase) or diabetes (FBG >100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score >=3, without a clinical diagnosis of pancreatic cancer within one year. | 6-monthly for 3 years |
| Number of Non-PDAC Cancer Diagnoses | Number of non-PDAC cancer detected through blood-based assays, EUS and/or MRI during the active screening period. | 6-monthly for 3 years |
| Clinical Predictors of Neoplastic Development | Frequencies of clinical predictors of neoplastic development as indicated by responses to the study surveys. | up to 8 years |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019160 | Endosonography |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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