Frequently Asked Questions (FAQ's)

What is the CAPS-3 study?

CAPS-3 stands for Cancer of the Pancreas Screening. One of the goals of the study is to find the best and most sensitive screening modality (CT, MRI, EUS) for small pre-cancerous pancreatic lesions, and to treat these small lesions before they turn into cancer.  Another study goal is to search for a gene mutation, or chemical markers that can be linked with the development of pancreatic cancer.  This study will screen the pancreas before there are any signs or symptoms of the disease. Currently, routine medical screening and testing for pancreatic cancer is not recommended for people who do not have symptoms or signs of pancreatic cancer.

Who is eligible for CAPS-3?

You may be able to join this study if you fit into one of the following three groups of people: 

  1. Someone who has been diagnosed by their doctor with Peutz-Jeghers Syndrome
  2. Someone who has at least two close relatives (parent, sibling or child) known to have pancreatic cancer, or
  3. Someone who is a known carrier of either the BRCA 2 gene, or the FAMMM/p16 gene and you have a close relative with pancreatic cancer.

How many people will be studied?

In total, about 200 people will be asked to join this study.

Besides joining the CAPS-3 study, what else can I do if my family has been affected by pancreatic cancer?

Many of the people who join this study already take part in the free Johns Hopkins-based National Familial Pancreatic Cancer Registry (NFPTR). Registries provide information to people who are all affected by a disease or at risk of a condition, and also collect information on those in the registry to learn more about that condition. If you are not part of the NFPTR, we suggest that you join the Registry. You can get information on joining the NFPTR at http://pathology2.jhu.edu/pancreas/nfptr.cfm, and you can decide whether you want to join it. Participation in the NFPTR is encouraged but not required to participate in this study.

What will happen if you join this study?

If you agree to be in this study, we will ask you to do the following things:

  1. Review a consent form that provides details of the study.
  2. Complete a questionnaire. The questions will ask about your family tree, your use of alcohol, caffeine and tobacco, perception of risk for pancreatic cancer, and other information about your medical history. Information in the questionnaire will allow us to prepare for your visit. This will take about 15 – 20 minutes to complete.
  3. Make an appointment to come to the CAPS-3 clinical center for a two day clinical visit.

What will happen during the first days of my visit during the CAPS-3 study?

The first time you come to the hospital, you will be seen by one of the study investigators who will review the study procedures, risks, and benefits described in the consent form with you . The investigator will perform a history and physical examination, and will take a blood sample.  You will also talk to a genetic counselor and have a Magnetic Resonance Imaging (MRI) scan of your abdomen.

Why is a blood sample taken?

We will take a blood sample that will be analyzed for trypsinogen, an enzyme that will detect if there is chronic scarring and inflammation of your pancreas.  The blood will be tested for certain protein and DNA changes as part of research on the early detection of pancreatic cancer and its precursors.

Why do I need to talk to a genetic counselor?

You will speak to a genetic counselor, who will review the questionnaire with you, discuss your family history of pancreatic cancer, discuss your risk of developing pancreatic cancer, and discuss what is currently known about the genetics of pancreatic cancer.   

Why do Magnetic Resonance Imaging (MRI) in CAPS-3?

MRI is useful for spotting and distinguishing diseased tissues (tumors and other lesions) early in their development.  During the MRI, an MRCP (Magnetic Resonance CholangioPancreatography), a special technique for visualizing your pancreas and bile duct, will be performed before and after a  drug called secretin is injected into your IV. Secretin is a naturally-occuring hormone produced by your pancreas, which stimulates secretion of pancreatic juice.  It is given to improve the pictures of your pancreatic duct. It is approved by the Food and Drug Administration (FDA) for stimulating pancreatic juices. The MRI-MRCP test will take about 45 minutes. After your appointments on Wednesday, your IV will be removed and you can go home.

What will happen during the second day of my visit during the CAPS-3 study?

You will have a CT scan of your abdomen, including the area around your pancreas, and an endoscopy procedure combined with an ultrasound procedure (called EUS).  These procedures help us to take pictures of your pancreas.  As part of the EUS, we will collect juices from your pancreas.  We will give you one dose of a drug called secretin to help your pancreas produce juice.  This time, secretin is given to stimulate pancreatic juice so we can collect a sample to study. During the EUS, we may find that the areas we look at appear to be normal.   

What happens if the EUS finds areas of the pancreas that do not look normal?

If the EUS shows an area that is abnormal, we will do a procedure called a Fine Needle Aspiration (FNA) using the ultrasound images to guide the needle into the area.  An FNA is a way to collect tissue samples that can be tested for cancer. There is no pain involved with an FNA. We will also collect some samples for research.

What happens if the investigators see signs of cancer?

If the EUS and FNA results indicate signs of cancer or obstruction of your pancreas or bile duct, we will ask you to have an Endoscopic Retrograde CholangioPancreatography(ERCP) procedure for clinical reasons. The ERCP is a endoscopy test combined with x-rays following injection of contrast or dye into your bile duct or pancreatic duct to get brushings or samples or place a stent(a piece of plastic tubing) to treat any blockage. These are standard tests/treatments for evaluating signs of cancer.  This ERCP procedure will be scheduled on another day.  You would have to be sedated or be under anesthesia to have the ERCP. 

What happens if there are any problems with the endoscopic procedures?

The ERCP can usually be done in one outpatient visit.  Some people, however, have problems after an ERCP and have to stay in the hospital overnight.  If you plan to fly into town for your screening procedures it would be best to get an unrestricted return ticket and consider leaving the next evening.  After you return home following the ERCP, we will call you in about three days or a week to find out if you had any problems after the procedure. 

What else happens after your clinical visits are over?

We will ask you some questions about your experience during the research screening procedures.  Also, we will ask you if you thought the genetic counseling provided during the screening was helpful to you. We will send you a letter that summarizes the results of the screening tests.  If you wish, you can give a copy of this to your doctor(s) with the reports of your screening tests.  We can also make recommendations on medical follow-up you might want to consider after the study ends. 

What are the risks or discomforts of the study?

Endoscopy:  Side effects are possible with endoscopic procedures.  The most common possible side effects of an endoscopic procedure include sore throat or a reaction to the medications used to put you to sleep.  Less common are complications that include bleeding, infection, and perforation of your esophagus, stomach, or intestine but are possible for any endoscopy.   The risk of these complications is low (about 1 in 1000) when performed by an experienced physician.

CT: Abdominal CT scan, exposes you to radiation exposure (0.545 rems). This is a low level and is not harmful.

MRI:  There are no known major risks with an MRI exam.  Some people feel confined (claustrophobia) during the procedure.

Contrast during MRI:   The contrast agent is used routinely for MRI exams.  The injection of contrast does not cause pain, but may cause discomfort, tingling or warmth in the lips, metallic taste in the mouth, tingling in the arm, nausea, or headache.  These symptoms occur in less than 1% (less than 1 in 100) of people and go away quickly.  Very rarely, there is an allergic reaction, but there is less than a one in 300,000 chance that this reaction will be severe. Insertion of the needle (small plastic tube) may also cause minor pain, bruising and/or infection at the injection site.   

Secretin: There is a small chance (about 1 in 12) that you could have a reaction to secretin. The possible side effects of the drug include nausea, flushing, or abdominal pain.  Some people, especially those with asthma, have an allergic reaction to secretin. Allergic reactions will be treated if they occur.

Test results:  Some patients may feel anxious when they get either abnormal or possibly abnormal screening EUS results.   

FNA:  The FNA done to collect research tissue samples has the same risks as the FNA done to collect samples for diagnosis.  These possible side effects include acute pancreatitis, which may occur in 1 to 2 of 100 procedures.  This is an inflammation of the pancreas that causes upper abdominal pain, with or without nausea and vomiting.  If you develop pancreatitis, you would probably have to stay in the hospital to treat it. 

ERCP:  An ERCP can also cause pancreatitis. About 7 people out of 100 have pancreatitis after an ERCP.  Very rarely, people with pancreatitis after ERCP have problems that can cause death.

What happens to Data, Tissue, Blood and Samples that are collected in the study?

The data, tissue, blood and samples collected from you during this study are important to both this study and to future research. If you join this study:

  • Johns Hopkins and/or its outside partners in this research will own these data, tissue, blood and samples.
  • Scientists may only use materials or data that identify you for future research with your consent or IRB approval.
  • If this material is used to create a product or idea, the scientists and Johns Hopkins will own that product or idea.
  • You will not receive any financial benefit from the creation, use or sale of that product or idea.

Are there benefits to being in the study?

This is a screening study, and you may or may not have any medical benefit from having screening procedures.  If the screening shows that you have cancer, it will be found at a very early stage.  Treating cancer early in the disease often produces a higher chance of being cured.  If you are not diagnosed with cancer, you will not have any medical benefit from being in the study.  In the future the information we collect in the study may help to diagnose pancreatic cancer earlier in people at risk for the disease.

Can you leave the study early?

You can agree to be in the study and change your mind later.

What is CT?

CT stands for Computed Tomography.  It is a non-invasive medical imaging method which takes x-rays in slices of a specified area.  CT uses an IV contrast to get the best image of your pancreas.  We will use state of the art CT technology to obtain 3-D very refined imaging of the pancreas.  This CT is also called a “spiral CT”, “helical CT” or “64 contrast CT”.  Some people may have an allergy to contrast.

What is MRI/ MRCP? 

MRI stands for Magnetic Resonance Imaging.  MRCP is Magnetic Resonance CholangioPancreatography. This will also get an image of your pancreas non-invasively.  It is different from CT because it will allow us to get an image of your pancreas in slices as it functions.  We will not use contrast for this procedure but you will receive a synthetic pancreatic hormone called “secretin” which will allow us to get an image of the ducts in your pancreas as they fill with pancreatic fluid.  

Will it hurt?

You will have an I.V. needle placed in your hand or arm on both days of the CAPS-3 clinical visits.  Placing the needle has been described as a strong pinch.  We can not keep the same I.V. overnight.  The I.V. is needed for receiving contrast, sedation and other medications and fluid.  It will also allow us to collect a specimen of your blood.

Endoscopic Ultrasound:   You will receive sedation for the procedure, so most people do not remember the procedure at all.  You may gag initially as the scope is passed into your esophagus (usually takes one good swallow on the patient's part); due to the sedation most patients do not remember this.   Once the scope is passed, taking slow deep breaths will help you relax.  You may experience some bloating related to the air used to view your GI tract.  Burping or passing gas will help with that feeling.  Our goal is to keep you as comfortable as safely possible.  

What medications will I receive during the study?

You will receive a contrast dye through your I.V. for the CT scan.  You will receive a synthetic pancreatic hormone (secretin) for the MRCP that allows us to check the function of the pancreas. You will not require sedation for either the CT or MRI/MRCP

Typically, patients receive two medications for sedation before and during the endoscopic ultrasound procedure.  We usually use a sedative (midazolam/ versed) to help you relax, and a narcotic (fentanyl) to make you sleepy.  You will receive (secretin) to help the pancreas release pancreatic fluid, which will be collected and analyzed for the study.Secretin  is currently under study for this use by the Food and Drug Administration (FDA).   If you have allergies to any of these medications please let the study investigator or the research nurse coordinator know.

Will I be asleep?

The sedation used in endoscopy is called "Conscious Sedation".   Most people are sleepy but may be able to talk and move, if requested to do so.  You may not remember doing so afterwards.

Who will be in the room with me?

At various stages of the EUS procedure the study investigator, usually another physician, 1-2 registered nurses and the research nurse will assist with the procedure.  A technician will collect/ transport some specimens.   They are all specially trained in endoscopic procedures.

How much time do the procedures take?

Endoscopic Ultrasound will take about 60 minutes. You will register 30 minutes before the procedure and be in the recovery room for about 30-60 minutes.

The CT will take about 30 minutes, with 30 minutes for registration.

The MRI/MRCP will take about 45 minutes, with 30 minutes for registration.

Procedures can take more or less time and vary from person to person.

How long do I have to stay after my procedure is completed?

On average, patients are observed for 30-60 minutes (this can take longer depending on how well the patient is recovering) after their EUS procedure.   After you have had something to drink, have been able to sit up, have stable vital signs, and are able to ambulate unassisted, you and your companion will be free to leave. (You cannot leave without an adult to escort you home or to your hotel.)

When/What can I eat afterwards?

You can eat and drink normally afterwards, although we recommend starting with a light meal if you are bloated, and advancing your diet as tolerated.  

Can I go back to work that day?

Do not work on the day of the procedure.   You may return to work the following day provided that your physician has not recommended otherwise.   We can provide you with a form for your employer if needed.

Can I take a cab home by myself?

No.   You can not leave by yourself. You must have an adult pick you up in the endoscopy unit and escort you home or to your hotel.  Please contact the study nurse coordinator if you do not have a person to take you home

***DUE TO THE SEDATION GIVEN DURING THE PROCEDURE, WE CANNOT PERFORM YOUR PROCEDURE UNLESS YOU HAVE AN ADULT WHO CAN PICK YOU UP IN THE ENDOSCOPY UNIT AFTER YOUR PROCEDURE AND ESCORT YOU HOME.   IN THE INTEREST OF PATIENT SAFETY, THERE CAN BE NO EXCEPTIONS TO THIS.

When will I receive my results?

The study investigator will talk to you and your family after the procedure.  You will also receive a follow-up call within a week after the procedure.  If you have had any biopsies (FNA) done, it may take several days before the results are ready.   You will obtain those results from the study investigator in a telephone call.

What will the schedule be for the two days?

On day one of the clinical visit the study nurse will meet you at Johns Hopkins Hospital. The study nurse will ask for the original consent you signed and faxed, and have you sign a duplicate, if you did not mail back your signed consent earlier. The study nurse will take you to your first appointment (either the genetic counselor or the MRI/MRCP); after that you will go to the next appointment (the MRI/MRCP or genetic counselor). At the MRI pre-procedure, the study nurse will collect 5 tubes of blood (less than 5 Tablespoons) when the IV is started for the procedure. You will have the MRCP and that will be it for the first day.  You should not have anything to drink after midnight for the  second day, the study nurse will meet you in the morning and take you to register for your CT scan and have that screening done.  After the CT you will register for the EUS and meet with the study investigator to discuss the procedure and have that completed.  If the study investigator sees anything unusual with your pancreas, a Fine Needle Aspiration (FNA) will be done in addition to the EUS in the same procedure time. You and your companion (if you wish) will meet with the study investigator after the procedure to discuss the procedure.  You may not remember the discussion completely due to the sedation medication, so a follow–up information letter will be sent to you also.

Glossary

First Degree Relative (FDR) - A blood relative who is most closely related (parent, sibling, child), by one ‘step’.

Second Degree Relative(SDR) - A blood relative who is related by two ‘steps’. i.e., A relative with whom one quarter of an individual's genes is shared (i.e., grandparent, grandchild, uncle, aunt, nephew, niece, half-sibling).

Carrier - a person who carries both a recessive, disease-causing type of a gene and a normal type of that same gene, both passed down from previous generations and both which may be passed to subsequent generations.

Peutz-Jeghers Syndrome - Peutz-Jeghers syndrome is an autosomal dominant hereditary disease, meaning that having an altered Peutz-Jeghers associated gene passed from only one parent is sufficient to increase the risk of the disease.  It  is characterized by hamartomatous polyposis and mucocutaneous pigmentation (small dark-colored spots) mainly over the circum-oral region. OccaGastrointestinal tract malignancies have been reported in Peutz-Jeghers syndrome

FAMMM - The Familial Atypical Multiple Mole-Melanoma Syndrome (FAMMM) is an inherited condition that increases the risk of malignant melanoma and is characterized by atypical moles or a high mole count and having one or more   first- or second- degree relatives with malignant melanoma. In individuals with FAMMM syndrome (and another ‘CDKN2A’  mutation) pancreatic cancer is the second most common cancer after melanoma

BRCA 2 - Breast cancer 2 or early onset (BRCA2) gene. In addition to breast cancer in men and women, mutations in BRCA2 can also lead to an increased risk of ovarian, prostate, and pancreatic cancers. BRCA2 is a tumor suppressor gene, and prevents cells from growing or dividing in an uncontrolled manner. As mutations build up, control is lost and a tumor may form.

Trypsinogen - Trypsinogen is the precursor form of the pancreatic enzyme trypsin. It is found in pancreatic juice, along with amylase, lipase, and chymotrypsinogen. Serum trypsinogen is measured using a blood test. The level of trypsinogen can indicate conditions that involve abnormalities of the pancreas, such as  acute pancreatitis, cystic fibrosis, and possibly pancreatic cancer.

NFPTR-National Familial Pancreatic Tumor Registry - The NFPTR is a confidential research registry that was established at Johns Hopkins University in 1994 by a multi-disciplinary team of scientists and doctors to learn more about pancreatic tumors, including why they seem to run in some families.

MRI/MRCP - Magnetic resonance imaging/ magnetic resonance imaging cholangiopancreatography

Magnetic resonance imaging (MRI) produces clear, detailed pictures of organs and structures of the body using a powerful magnetic field, radio waves, and a computer to create cross-sectional images.  MRCP refers to specific magnetic resonance technology to produces a 3-D image defining the biliary tract and pancreatic ducts.

Computed tomography is a non-invasive medical imaging method that takes cross-sectional x-ray images of a specified area.

Informed Consent – A process (oral, written, or both) in which complete information regarding participation in a specific research protocol is presented to the subject or the subject’s legally authorized representative in understandable language. Consent is sought under circumstances which provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and with no undue influence. Informed consent can not include language which waives any of the subject’s legal rights or releases the investigator, sponsor, institution or its agents from liability for negligence. Informed consent must be documented using the terms and conditions that have been approved by the Institutional Review Board (IRB) and signed by the subject or the subject’s legally authorized representative.