A Study to Compare Colon Lavage Fluids for Pancreatic Cancer Marker Validation
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 20-005872
Sponsor Protocol Number: CRTX1-201
About this study
The purpose of this study is to compare the proteomic markers from gastrointestinal lavage fluid collected from patients with a pancreatic mass to a control group of otherwise healthy subjects.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - Pancreatic Mass Subjects:
- Male or female patients that have been diagnosed with a pancreatic mass and/or Pancreatic Cancer via one of the following methods:
- Computed tomography (CT);
- Endoscopic ultrasound (EUS);
- Magnetic resonance imaging (MRI);
- Fine Needle Aspiration (FNA) Biopsy;
- Brush Biopsy;
- Laparoscopy.
- At least 45 years of age.
- Negative urine pregnancy test at screening, if applicable.
- In the Investigator’s judgment, subject is mentally competent to provide informed consent to participate in the study.
Inclusion Criteria – Healthy Control Subjects:
- Male or female subjects undergoing colonoscopy for routine clinical indications to include colon cancer screening or polyp surveillance.
- At least 45 years of age.
- Negative urine pregnancy test at screening, if applicable.
- In the investigator’s judgement, subject is mentally competent to provide informed consent to participate in the study.
Exclusion Criteria:
- The subject or investigator feels the subject will be unable to complete the bowel preparation.
- If Applicable: The pancreatic mass under evaluation has been previously determined to be a pseudocyst or otherwise benign mass.
- If Applicable: The pancreatic mass under evaluation has been previously determined to be malignant AND the subject is currently undergoing chemotherapy or radiation therapy.
- Subjects with any past diagnosis of non-Pancreatic cancer.
- NOTE: Subjects previously diagnosed and treated for cancerous skin lesions may be considered for study inclusion.
- Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon that would put them at risk during bowel preparation.
- Subjects who, in the opinion of the Principal Investigator, have uncontrolled clinically significant pre-existing electrolyte disturbances (such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia or dehydration) that would put them at risk during bowel preparation.
- Subjects who are pregnant or lactating, or intending to become pregnant during the study.
- Subjects of childbearing potential who refuse a pregnancy test.
- Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
- NOTE: Subjects participating in observational or diagnostic studies may be considered for inclusion.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available