Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt CC
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.
| Condition | Intervention |
|---|---|
|
Pancreatic Cancer |
Procedure: Endoscopic Ultrasound (EUS) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center |
- Number of Abnormalities Detected by EUS [ Time Frame: Average of 5 years ] [ Designated as safety issue: No ]To determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer.
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Endoscopic Ultrasound (EUS) Participants
High-risk for Pancreatic Cancer: Patients with 2 or more relatives with pancreatic cancer and a first degree relationship with at least one of the relatives with pancreatic cancer.
|
Procedure: Endoscopic Ultrasound (EUS)
Ultrasound scope will be passed through the participant's mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. If an abnormality is found in their pancreas, a biopsy may be performed to obtain a diagnosis.
Other Name: ultrasound scope
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Individuals potentially at high-risk for developing pancreatic cancer.
Inclusion Criteria:
Patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer
- If only 2 family members are affected then both must have had pancreatic cancer and a first-degree relationship with individual screened
- If there are more than 2 affected individuals on the same side of the family at least one of the individuals must have a first-degree relationship with the member being screened
- Patients at least 40 years old or 10 years younger than the youngest affected individual
- Peutz-Jeghers Syndrome (PJS) patients age>30
- Hereditary pancreatitis patients
- Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM)
- Patients with BRCA2 mutation and at least one first or second degree relative with documented pancreatic cancer
- Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA)
- Willingness to undergo surgical evaluation for abnormal EUS/FNA finding
- Willingness to undergo radiographic evaluation if screening findings are abnormal
Exclusion Criteria:
- Medical contraindications to undergoing endoscopy or obstruction of the GI tract that precludes passage of the endoscope
- Personal history of pancreatic adenocarcinoma
- Previous partial or complete resection of the pancreas for adenocarcinoma
- Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis
- Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years
- Coexisting cancer in other organs or acquired immunodeficiency syndrome/human immunodeficiency virus (AIDS/HIV)
- Life expectancy less than 5 years
- Pregnancy
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Tiffany Campos 813-745-8358 tiffany.campos@moffitt.org | |
| Principal Investigator: Jason Klapman, M.D. | |
| Sub-Investigator: Barbara Centeno, M.D. | |
| Sub-Investigator: Pamela Hodul, M.D. | |
| Sub-Investigator: Mokenge Malafa, M.D. | |
| Sub-Investigator: Gregory Springett, M.D., Ph.D. | |
| Sub-Investigator: Shivakumar Vignesh, M.D. | |
| Principal Investigator: | Jason Klapman, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01662609 History of Changes |
| Other Study ID Numbers: | MCC-14882 |
| Study First Received: | August 8, 2012 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
pancreas high-risk |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013