Trials / Recruiting
RecruitingNCT06122896
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 5,000 (estimated)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
- Pancreatic Cancer
- Pancreatic Ductal Adenocarcinoma
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
- Pancreatic Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Screening Blood Tests | Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care. |
| DIAGNOSTIC_TEST | Endoscopic Ultrasound | Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. |
| COMBINATION_PRODUCT | Magnetic Resonance Imaging | Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. |
| COMBINATION_PRODUCT | Magnetic Resonance Cholangiopancreatography | Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines. |
Timeline
- Start date
- 2023-11-21
- Primary completion
- 2040-10-31
- Completion
- 2041-10-31
- First posted
- 2023-11-08
- Last updated
- 2025-06-03
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06122896. Inclusion in this directory is not an endorsement.