Pancreatic CancerNCT01102556
PANCREATIC DISEASE COHORT A Registry and Biospecimen Bank to Better Understand Pancreatic Disease
An observational study of Pancreatic Cancer, run by Columbia University at 1 site in United States.
Trial summary
The specific aims of this project are to create a registry, as well as a biospecimen bank for individuals with pancreatic disease (e.g. pancreatic adenocarcinoma, pancreatitis, intraductal papillary mucinous neoplasm (IPMN) mucinous cystic neoplasm (MCN), and pancreatic intraepithelial neoplasia (PanIN) or have been… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who have been diagnosed with pancreatic cancer or suspicion of pancreatic cancer, a pre-neoplastic lesion in the pancreas, or who have been identified to be at high-risk for developing pancreatic cancer.
Who may be able to join
- Individuals who have been diagnosed with pancreatic cancer or suspicion of pancreatic cancer, a pre-neoplastic lesion in the pancreas who are 18 years or older
- Individuals identified to be high risk for developing pancreatic cancer who are 18 years or older based on the following criteria:
- The modified clinical Bethesda criteria for hereditary nonpolyposis colorectal cancer (HNPCC), which are as follows: individuals with 2 HNPCC-associated cancers (colon, endometrial, small bowel, hepatobiliary, pancreatic, genitourinary, or gastric), including synchronous or metachronous lesions; individuals with colon cancer and a first degree relative with an HNPCC-associated tumor and/or colonic adenoma (1 cancer diagnosed at age <45 years and the adenoma diagnosed at age <40 years); individuals with colon or endometrial cancer diagnosed at <50 years; individuals with right-sided colon cancer having an undifferentiated pattern (solid/cribiform) or signet cell histopathology diagnosed at <45 years; or individuals with adenomas diagnosed at <40 years.
- Those with a personal or family history of other pancreatic cancer associated syndromes including: Peutz-Jeghers syndrome, familial pancreatic cancer syndrome, familial breast cancer syndrome associated with BReast CAncer genes 1 or 2 (BRCA-2 or BRCA-1), hereditary pancreatitis, familial atypical multiple mole melanoma, and others.
- Patients in a family with a genetically determined cancer predisposition syndrome.
- Patients with a personal history of a gastrointestinal malignancy at age <45 years.
- Individuals at high-risk based on personal or family history, but not related to a known pancreatic cancer syndrome include the following: those with a personal history of pancreatic cancer, or a pre-neoplastic pancreatic lesion; those with a family history of two or more individuals with cancer, at least one of which is reported to be a gastrointestinal malignancy; a history of early onset (<50 years) gastrointestinal cancer in the individual or a family member; a history of multiple primary cancers, at least one of which is a gastrointestinal primary, or a family member of an individual meeting this criterion.
Who cannot join
- Inability to obtain informed consent for study enrollment.
- Under the age of 18 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Beth Schrope, MD, PhD, FACS contact
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Vilma Rosario, 212-305-6033, vr2222@cumc.columbia.edu
Beth Schrope, MD, PhD, FACS
About this study
Official title: PREDICT: Pancreatic Disease Cohort. A Registry and Biospecimen Bank To Better Understand Pancreatic Disease.
The specific aims of this project are to create a registry, as well as a biospecimen bank for individuals with pancreatic disease (e.g. pancreatic adenocarcinoma, pancreatitis, intraductal papillary mucinous neoplasm (IPMN) mucinous cystic neoplasm (MCN), and pancreatic intraepithelial neoplasia (PanIN) or have been determined to be at high-risk for pancreatic cancer. Biospecimen can be defined as blood, urine, tissue, stool, or saliva samples. Therefore, no hypothesis is to be tested. The personal data derived from the registry, correlated with biological information derived from the biospecimens will allow for future investigative studies of pancreatic cancer etiology and tumor biology. The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. It is anticipated that the knowledge derived will ultimately lead to improvements in the diagnosis, prevention, detection,and treatment of pancreatic cancer.
Read the detailed description
Pancreatic cancer is the fourth leading cause of cancer death in both men and women in the United States. According to the American Cancer Society facts and figures, approximately 43,920 people in the United Sates will be diagnosed with pancreatic cancer in 2012, and it is expected that 37,390 will die from the disease. The dismal prognosis of the disease is clearly depicted by the fact that its incidence approximates its mortality. Pancreatic cancer has a 95% case fatality rate. The etiology of pancreatic cancer remains elusive and our knowledge of its precursors and natural history is preliminary and incomplete. The uniform fatality of the disease merits priority attention in the search for its cause.
Due to the rapid progression of the disease, early detection and prevention provides the best hope for reducing morbidity and mortality. However, the few screening tests available for early detection and/or prevention of neoplastic lesions are poorly studied and prohibitively impractical in the general population. Further, few pancreatic cancer risk factors are well established or widely accepted. Advanced age, family history, cigarette smoking, diabetes, and some dietary risk factors are established or suspected risk factors.
Due to the high volume of individuals seen at the pancreas center, we plan on enrolling 500+ individuals per year who have either been diagnosed with pancreatic disease or are at high risk for developing pancreatic cancer. All participants enrolled during a clinic/non clinic visit at Columbia University Medical Center (CUMC) will undergo a baseline visit and up to 3 subsequent visits. Additionally, based on the different conditions of pancreatic disease that we are enrolling, not all subjects will participate in all aspects of the program. For example, only individuals with cancer or pre-neoplastic lesions will have tissue collected and banked.
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Pre-Neoplastic Lesions, Pancreatic Cancer Surgery, High-Risk for Pancreatic Cancer, Tissue and Blood Bank for Pancreatic Cancer, Pancreatic Cancer Questionnaire
- Medical subject headings
- Pancreatic Neoplasms
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 |
|---|---|---|
| Surgery Patients/High-risk Patients | Patients who have undergone surgery for pancreatic cancer or pre-neoplastic lesions of the pancreas will be accrued to the study. In addition, patients who are determined to be at high-risk for pancreatic cancer (with a significant family history) will also be recruited for study enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a registry and blood/tissue bank
The primary aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer.
Measured: 1 year
Secondary outcomes (1)
Improvement in the diagnosis, prevention, detection, and treatment of pancreatic cancer.
The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. The epidemiological data will be correlated with the biological information and will allow for future investigative studies of pancreatic cancer etiology and tumor biology. It is anticipated and hypothesized that the knowledge derived will lead to improvements in the diagnosis, prevention, detection, and treatment of pancreatic cancer.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startJul 2004
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
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 Columbia UniversityThe 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
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth Schrope, MD, PhD, FACS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102556
- Sponsor's protocol ID
- AAAA6154
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2010
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT: Pancreatic Disease Cohort. A Registry and Biospecimen Bank To Better Understand Pancreatic Disease.
- ClinicalTrials.gov ID
- NCT01102556
- Acronym / sponsor ID
- AAAA6154
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Pre-Neoplastic Lesions, Pancreatic Cancer Surgery, High-Risk for Pancreatic Cancer, Tissue and Blood Bank for Pancreatic Cancer, Pancreatic Cancer Questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jul 2004 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Apr 2010 (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 specific aims of this project are to create a registry, as well as a biospecimen bank for individuals with pancreatic disease (e.g. pancreatic adenocarcinoma, pancreatitis, intraductal papillary mucinous neoplasm (IPMN) mucinous cystic neoplasm (MCN), and pancreatic intraepithelial neoplasia (PanIN) or have been determined to be at high-risk for pancreatic cancer. Biospecimen can be defined as blood, urine, tissue, stool, or saliva samples. Therefore, no hypothesis is to be tested. The personal data derived from the registry, correlated with biological information derived from the biospecimens will allow for future investigative studies of pancreatic cancer etiology and tumor biology. The long-term goals of the study are to advance the knowledge of the etiology and epidemiology of pancreatic cancer. It is anticipated that the knowledge derived will ultimately lead to improvements in the diagnosis, prevention, detection,and treatment of pancreatic cancer.
Detailed description
Pancreatic cancer is the fourth leading cause of cancer death in both men and women in the United States. According to the American Cancer Society facts and figures, approximately 43,920 people in the United Sates will be diagnosed with pancreatic cancer in 2012, and it is expected that 37,390 will die from the disease. The dismal prognosis of the disease is clearly depicted by the fact that its incidence approximates its mortality. Pancreatic cancer has a 95% case fatality rate. The etiology of pancreatic cancer remains elusive and our knowledge of its precursors and natural history is preliminary and incomplete. The uniform fatality of the disease merits priority attention in the search for its cause.
Due to the rapid progression of the disease, early detection and prevention provides the best hope for reducing morbidity and mortality. However, the few screening tests available for early detection and/or prevention of neoplastic lesions are poorly studied and prohibitively impractical in the general population. Further, few pancreatic cancer risk factors are well established or widely accepted. Advanced age, family history, cigarette smoking, diabetes, and some dietary risk factors are established or suspected risk factors.
Due to the high volume of individuals seen at the pancreas center, we plan on enrolling 500+ individuals per year who have either been diagnosed with pancreatic disease or are at high risk for developing pancreatic cancer. All participants enrolled during a clinic/non clinic visit at Columbia University Medical Center (CUMC) will undergo a baseline visit and up to 3 subsequent visits. Additionally, based on the different conditions of pancreatic disease that we are enrolling, not all subjects will participate in all aspects of the program. For example, only individuals with cancer or pre-neoplastic lesions will have tissue collected and banked.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery Patients/High-risk Patients | – | –Patients who have undergone surgery for pancreatic cancer or pre-neoplastic lesions of the pancreas will be accrued to the study. In addition, patients who are determined to be at high-risk for pancreatic cancer (with a significant family history) will also be recruited for study enrollment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have been diagnosed with pancreatic cancer or suspicion of pancreatic cancer, a pre-neoplastic lesion in the pancreas, or who have been identified to be at high-risk for developing pancreatic cancer.
Key inclusion criteria (7 listed)
- Individuals who have been diagnosed with pancreatic cancer or suspicion of pancreatic cancer, a pre-neoplastic lesion in the pancreas who are 18 years or older
- Individuals identified to be high risk for developing pancreatic cancer who are 18 years or older based on the following criteria:
- The modified clinical Bethesda criteria for hereditary nonpolyposis colorectal cancer (HNPCC), which are as follows: individuals with 2 HNPCC-associated cancers (colon, endometrial, small bowel, hepatobiliary, pancreatic, genitourinary, or gastric), including synchronous or metachronous lesions; individuals with colon cancer and a first degree relative with an HNPCC-associated tumor and/or colonic adenoma (1 cancer diagnosed at age <45 years and the adenoma diagnosed at age <40 years); individuals with colon or endometrial cancer diagnosed at <50 years; individuals with right-sided colon cancer having an undifferentiated pattern (solid/cribiform) or signet cell histopathology diagnosed at <45 years; or individuals with adenomas diagnosed at <40 years.
- Those with a personal or family history of other pancreatic cancer associated syndromes including: Peutz-Jeghers syndrome, familial pancreatic cancer syndrome, familial breast cancer syndrome associated with BReast CAncer genes 1 or 2 (BRCA-2 or BRCA-1), hereditary pancreatitis, familial atypical multiple mole melanoma, and others.
- Patients in a family with a genetically determined cancer predisposition syndrome.
Key exclusion criteria (2 listed)
- Inability to obtain informed consent for study enrollment.
- Under the age of 18 years old.
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
Creation of a registry and blood/tissue bank
Time frame: 1 year
The primary aims of this project are to create a registry, and blood and tissue bank for individuals at risk for pancreatic cancer.
1 secondary outcome
Improvement in the diagnosis, prevention, detection, and treatment of pancreatic cancer.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Beth Schrope, MD, PhD, FACS contact
Beth Schrope, MD, PhD, FACS principal investigator
Columbia 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 Pancreatic Cancer, run by Columbia University 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vilma Rosario (212-305-6033, vr2222@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a registry and blood/tissue bank (time frame: 1 year). 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 2 Apr 2026.