Pancreatic CancerNCT01662609
Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer
An observational study of Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Endoscopic Ultrasound (EUS)
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Aug 2007to 16 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals potentially at high-risk for developing pancreatic cancer.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18105
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Endoscopic Ultrasound (EUS)
- Keywords
- pancreas, high-risk
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound (EUS)Procedure or surgery
Also called ultrasound scope
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endoscopic Ultrasound (EUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Abnormalities Detected by EUS
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.
Measured: Average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study start23 Aug 2007
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aamir Dam, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662609
- Sponsor's protocol ID
- MCC-14882
- Status last verified
- Oct 2022
- First submitted
- 8 Aug 2012
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital
- ClinicalTrials.gov ID
- NCT01662609
- Acronym / sponsor ID
- MCC-14882
- Conditions
- Pancreatic Cancer
- Keywords
- pancreas, high-risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 23 Aug 2007 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Ultrasound (EUS) Participants | – | Procedure: Endoscopic Ultrasound (EUS)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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals potentially at high-risk for developing pancreatic cancer.
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Ultrasound (EUS)Also: ultrasound scopeUltrasound 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. | Procedure or surgery | Endoscopic Ultrasound (EUS) Participants |
Primary outcome
Number of Abnormalities Detected by EUS
Time frame: Average of 5 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aamir Dam, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Abnormalities Detected by EUS (time frame: Average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022; AzTrials last refreshed its copy on 4 Nov 2026.