Early Pancreatic NeoplasiaCAPS4NCT00714701
Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)
An observational study of Early Pancreatic Neoplasia and Familial Pancreatic Neoplasia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of screening patients with an increased inherited risk for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Pancreatic Neoplasia, Familial Pancreatic Neoplasia
- How many people
- 631 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2016
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: asymptomatic high risk patients
Who may be able to join
- High Risk Group 1 (familial Peutz-Jeghers syndrome):
- At least 30 years old and <100 years old, and
- at least 2 of 3 criteria diagnostic of Peutz-Jeghers syndrome (characteristic intestinal hamartomatous polyps, mucocutaneous melanin deposition, or family history of Peutz-Jeghers syndrome)
- known STK-11 gene mutation carrier
- High Risk Group 2 (familial pancreatic cancer relatives):
- > 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and < 80 years old
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- come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and
- have a first-degree relationship with at least one of the relatives with pancreatic cancer.
- If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened
- High Risk Group 3 (germline mutation carriers):
- > 40 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and< 80 years old
- patient is carrier of a known BRCA1, BRCA2, PALB2, or FAMMM (p16/CDKN2A) mutation, and there is > 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.
- Hereditary pancreatitis syndrome
- High Risk Group 4 (young-onset pancreatic cancer relative):
- > 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and < 80 years old
- have a first-degree relationship with at least one relative with young-onset pancreatic cancer ( age of onset < 50 years)
- High risk group 5 (both parents affected)
- > 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and< 80 years old
- two parents affected by pancreatic cancer
- Control 1 (Negative Controls):
- are undergoing EUS and/or ERCP for non-pancreatic indications as part of their standard medical care, and
- have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer)
- Control 2 (Chronic Pancreatitis)
- are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven chronic pancreatitis as part of their standard medical care, and,
- have no clinical or radiologic suspicion of pancreatic cancer
- Control 3 (Pancreatic Cancer)
- are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence)
- Control 4 (Intraductal Papillary Mucinous Neoplasm or IPMN) a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic cancer precursor, intraductal papillary mucinous neoplasm (based on clinical presentation and radiologic or prior EUS or radiologic evidence of a dilated main pancreatic duct and/or pancreatic cystic lesion communicating with the pancreatic ductal system)
- Additional requirements for eligible high risk patients: i) All persons with known genetic mutation must have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory. ii) A good faith attempt should be made to confirm pancreatic cancers in the family members via registration in a pancreatic cancer registry iii) The affected first degree relative of the person being screened must be confirmed by medical record or death certificate.
- All control patients must be > 18 and < 80 years old and no personal or family history of pancreatic cancer or a germline mutation linked to pancreatic cancer.
Who cannot join
- Patients will be excluded if they have any of the following:
- medical comorbidities or coagulopathy that contraindicate endoscopy,
- Karnosfky performance status of < 60,
- had partial or complete resection of their pancreas
- had a partial or complete gastrectomy with Billroth or Roux-en-Y anastomosis
- a stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
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- life expectancy less than 5 years due to coexisting advanced cancer or AIDS.
- inability to provide informed consent
- pregnant patient
- history of pancreatic cancer,
- suspicion of pancreatic neoplasia based on clinical history (weight loss, unexplained abdominal pain), physical examination (obstructive jaundice, cachexia), laboratory tests (cholestastic liver function tests, markedly elevated CA19-9), and/or imaging studies (pancreatic mass or cyst, dilated pancreatic and/or bile duct);
- there is no interest in undergoing treatment of pancreatic neoplasm(s) detected by screening.
- history of chronic kidney disease, serum creatinine > 2.0 mg/dl or estimated glomerulofiltration rate (eGFR) < 30 ml/min, ongoing acute renal failure, cirrhosis of the liver, chronic hepatitis (The estimated glomerulfiltration rate (eGFR) will be calculated based on age, race, and serum creatinine, using the on-line calculator at nephron.com).
- history of dementia
Trial locations and contacts
1 site in 1 country.
About this study
CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of screening patients with an increased inherited risk for pancreatic cancer.
Read the detailed description
Pancreatic cancer is a deadly disease and the only hope for improvement of survival is early detection. Certain genetic syndromes are associated with a high risk of pancreatic cancer and screening for pancreatic cancer has become a relatively new strategy for familial pancreatic cancer. . Our pancreatic cancer research group at Johns Hopkins and others have shown that screening with EUS and/or abdominal imaging tests such as CT/MRI can detect a relatively high number of significant pancreatic neoplasms (7-18%) in asymptomatic high risk individuals with an inherited predisposition for pancreatic ductal adenocarcinoma This is a clinical, early detection translational study that will directly influence patient care. This long term study follows the successful completion of single center Cancer of the Pancreas (CAPS) 1 and CAPS 2 studies at Johns Hopkins, and the ongoing CAPS 3 multicenter study. GENERAL AIM: This is a study that aims to evaluate the diagnostic yield, quality of life, and clinical outcomes of a clinical screening and surveillance program for individuals at-risk for pancreatic cancer and to validate a candidate panel of biomarkers for early detection of pancreatic neoplasia. The 3 specific groups to be screened and followed are individuals from familial pancreatic cancer kindreds (who have 2 or more affected relatives and have an estimated risk 16-57 times that of controls), patients with familial Peutz-Jeghers syndrome, patients with a known BRCA-2, BRCA-1, PALB2, PRSS or p16 germline mutation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High Risk Group 1 | familial Peutz-Jeghers syndrome | |
| High Risk Group 2 | familial pancreatic cancer relatives | |
| High Risk Group 3 | germline mutation carriers BRCA1, BRCA2, PRSS, PALB2, p16 | |
| High Risk Group 4 | young-onset pancreatic cancer relative | |
| High Risk Group 5 | both parents affected | |
| Control 1 | negative controls | |
| Control 2 | chronic pancreatitis | |
| Control 3 | pancreatic cancer | |
| Control 4 | intraductal papillary mucinous neoplasm (IPMN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
This clinical study will assess the diagnostic yield of a clinical screening program for early pancreatic neoplasia in high risk individuals.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Pancreatic NeoplasiaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The V Foundation for Cancer Research, ChiRhoClin, Inc.
- Responsible party
- Sponsor
- Investigators
- Marcia Irene F. Canto, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714701
- Sponsor's protocol ID
- J0139 00-04-14-10
- Other IDs
- J0139
- Acronym
- CAPS4
- Status last verified
- Sep 2018
- First submitted
- 9 Jul 2008
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: This study data is part of the CAPS Consortium Registry, an International registry for people screened for pancreas cancer.
Publications
Eshleman JR, Norris AL, Sadakari Y, Debeljak M, Borges M, Harrington C, Lin E, Brant A, Barkley T, Almario JA, Topazian M, Farrell J, Syngal S, Lee JH, Yu J, Hruban RH, Kanda M, Canto MI, Goggins M. KRAS and guanine nucleotide-binding protein mutations in pancreatic juice collected from the duodenum of patients at high risk for neoplasia undergoing endoscopic ultrasound. Clin Gastroenterol Hepatol. 2015 May;13(5):963-9.e4. doi: 10.1016/j.cgh.2014.11.028. Epub 2014 Dec 4.
PubMed 25481712Kanda M, Sadakari Y, Borges M, Topazian M, Farrell J, Syngal S, Lee J, Kamel I, Lennon AM, Knight S, Fujiwara S, Hruban RH, Canto MI, Goggins M. Mutant TP53 in duodenal samples of pancreatic juice from patients with pancreatic cancer or high-grade dysplasia. Clin Gastroenterol Hepatol. 2013 Jun;11(6):719-30.e5. doi: 10.1016/j.cgh.2012.11.016. Epub 2012 Nov 28.
PubMed 23200980
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)
- ClinicalTrials.gov ID
- NCT00714701
- Acronym / sponsor ID
- CAPS4 / J0139 00-04-14-10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- The V Foundation for Cancer Research, ChiRhoClin, Inc.
- Study start
- Jun 2008
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Jul 2008 (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.
CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of screening patients with an increased inherited risk for pancreatic cancer.
Detailed description
Pancreatic cancer is a deadly disease and the only hope for improvement of survival is early detection. Certain genetic syndromes are associated with a high risk of pancreatic cancer and screening for pancreatic cancer has become a relatively new strategy for familial pancreatic cancer. . Our pancreatic cancer research group at Johns Hopkins and others have shown that screening with EUS and/or abdominal imaging tests such as CT/MRI can detect a relatively high number of significant pancreatic neoplasms (7-18%) in asymptomatic high risk individuals with an inherited predisposition for pancreatic ductal adenocarcinoma This is a clinical, early detection translational study that will directly influence patient care. This long term study follows the successful completion of single center Cancer of the Pancreas (CAPS) 1 and CAPS 2 studies at Johns Hopkins, and the ongoing CAPS 3 multicenter study. GENERAL AIM: This is a study that aims to evaluate the diagnostic yield, quality of life, and clinical outcomes of a clinical screening and surveillance program for individuals at-risk for pancreatic cancer and to validate a candidate panel of biomarkers for early detection of pancreatic neoplasia. The 3 specific groups to be screened and followed are individuals from familial pancreatic cancer kindreds (who have 2 or more affected relatives and have an estimated risk 16-57 times that of controls), patients with familial Peutz-Jeghers syndrome, patients with a known BRCA-2, BRCA-1, PALB2, PRSS or p16 germline mutation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| High Risk Group 1 | – | –familial Peutz-Jeghers syndrome |
| High Risk Group 2 | – | –familial pancreatic cancer relatives |
| High Risk Group 3 | – | –germline mutation carriers BRCA1, BRCA2, PRSS, PALB2, p16 |
| High Risk Group 4 | – | –young-onset pancreatic cancer relative |
| High Risk Group 5 | – | –both parents affected |
| Control 1 | – | –negative controls |
| Control 2 | – | –chronic pancreatitis |
| Control 3 | – | –pancreatic cancer |
| Control 4 | – | –intraductal papillary mucinous neoplasm (IPMN) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- asymptomatic high risk patients
Key inclusion criteria (30 listed)
- High Risk Group 1 (familial Peutz-Jeghers syndrome):
- High Risk Group 2 (familial pancreatic cancer relatives):
- If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened
- High Risk Group 3 (germline mutation carriers):
- High Risk Group 4 (young-onset pancreatic cancer relative):
Key exclusion criteria (14 listed)
- medical comorbidities or coagulopathy that contraindicate endoscopy,
- Karnosfky performance status of < 60,
- had partial or complete resection of their pancreas
- had a partial or complete gastrectomy with Billroth or Roux-en-Y anastomosis
- a stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
This clinical study will assess the diagnostic yield of a clinical screening program for early pancreatic neoplasia in high risk individuals.
Time frame: 5 years
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 Sep 2018.
- Derived from this study: PubMed 25481712Eshleman JR, Norris AL, Sadakari Y, Debeljak M, Borges M, Harrington C, Lin E, Brant A, Barkley T, Almario JA, Topazian M, Farrell J, Syngal S, Lee JH, Yu J, Hruban RH, Kanda M, Canto MI, Goggins M. KRAS and guanine nucleotide-binding protein mutations in pancreatic juice collected from the duodenum of patients at high risk for neoplasia undergoing endoscopic ultrasound. Clin Gastroenterol Hepatol. 2015 May;13(5):963-9.e4. doi: 10.1016/j.cgh.2014.11.028. Epub 2014 Dec 4.
- Derived from this study: PubMed 23200980Kanda M, Sadakari Y, Borges M, Topazian M, Farrell J, Syngal S, Lee J, Kamel I, Lennon AM, Knight S, Fujiwara S, Hruban RH, Canto MI, Goggins M. Mutant TP53 in duodenal samples of pancreatic juice from patients with pancreatic cancer or high-grade dysplasia. Clin Gastroenterol Hepatol. 2013 Jun;11(6):719-30.e5. doi: 10.1016/j.cgh.2012.11.016. Epub 2012 Nov 28.
- Individual participant dataSharing planned: Yes. This study data is part of the CAPS Consortium Registry, an International registry for people screened for pancreas cancer.
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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.
Marcia Irene F. Canto, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Pancreatic Neoplasia and Familial Pancreatic Neoplasia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 30 inclusion and 14 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This clinical study will assess the diagnostic yield of a clinical screening program for early pancreatic neoplasia in high risk individuals. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00714701, which also lists 2 linked publications.
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 Sep 2018.