UPCC 30213 The Cancer of the Pancreas Screening-5 (CAPS5)
Study of Pancreatic Cancer Screening Methods
Brief description of study
Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.
Detailed description of study
The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation, Germline Mutation Carrier, Lynch Syndrome
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Hereditary Pancreatitis or
- Peutz-Jeghers Syndrome or
- Strong family history of pancreas cancer on one side of the family tree or
- Confirmed germline mutation carrier (BRCA2, FAMMM (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR
- Endoscopic evaluation of pancreas scheduled
Exclusion Criteria:
- Medical comorbidities or coagulopathy that contraindicate endoscopy
- Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis
- Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
- Poor performance status
- Inability to provide informed consent
- Pregnancy.
This study investigates screening methods for pancreatic cancer in individuals who are at high risk due to genetic factors or family history. The purpose of this study is to better understand the effectiveness of these screening methods in detecting early signs of pancreatic cancer.
Participants in this study will undergo procedures such as endoscopic evaluations, which involve using a flexible tube with a camera to view the pancreas. This helps doctors to look for any abnormalities. Participants will be closely monitored for any adverse events, and the study team will report these to the principal investigator.
- Who can participate: Eligible participants include those with hereditary pancreatitis, Peutz-Jeghers Syndrome, a strong family history of pancreatic cancer, specific genetic mutations, or those scheduled for an endoscopic evaluation of the pancreas.
- Study details: Participants will undergo endoscopic evaluations to screen for pancreatic cancer. The study will monitor and report any adverse events. Participants must be able to provide informed consent and should not have medical conditions that contraindicate endoscopy.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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