Pancreatic CancerNCT00661882
Pancreatic Cancer Collaborative Registry
An observational study of Pancreatic Cancer, run by University of Nebraska at 1 site in United States.
Trial summary
RATIONALE: Gathering information about patients with cancer may help doctors learn more about the disease and plan early diagnosis and treatment. PURPOSE: This clinical trial is studying computer tools for improving early diagnosis and treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or… Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- medical chart review, questionnaire administration and study of socioeconomic and demographic variables
- Type of treatment
- Surgery or procedure
- How many people
- 379 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to 9 Sep 2013
- 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 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be asked to voluntarily participate in this project because they have been diagnosed with PC, have a family history of PC, or fulfill the criteria to be one of the three different control groups meaning they will either have a diagnosis of chronic pancreatitis, acute biliary obstruction, or they are a healthy unaffected individual.
Patients Participants Inclusion Criteria:
Must meet 1 of the following criteria:
- Histologically confirmed adenocarcinoma of the pancreas
- Resectable stage I-IIA disease or stage IIB or higher disease Must have undergone complete surgical resection of the tumor with curative intent
- Pancreatic mass (solid) that is less than 4 cm as determined by any conventional imaging (MRI, EUS, or CT scan)
- No evidence of extension of the mass beyond the pancreas including vascular invasion or invasion into surrounding organs, with the exception of the bile duct
- No imaging evidence of metastatic disease or lymphadenopathy (lymph nodes greater than 1 cm and/or appearance suspicious for an advanced lesion by imaging criteria)
- Has a family history of pancreatic cancer and is considered to be an at-risk individual for the disease (i.e., member of a family with 2 or more individuals with pancreatic cancer)
Patients Participants Exclusion Criteria:
- No prior malignancy, except nonmelanoma skin cancer, for 10 years
- No prior preoperative chemoradiotherapy (neoadjuvant)
Control participants Inclusion Criteria:
Must meet 1 of the following criteria:
- Chronic pancreatitis OR history of exocrine insufficiency meeting the following criteria:
- At least 2 of the following criteria are met (unless patient has a history of pancreatic exocrine insufficiency in which case only 1 criterion must be met): Abdominal ultrasound that is consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci in the parenchyma, large or small cavities, calcifications, or dilated pancreatic duct) Abdominal CT scan consistent with chronic pancreatitis by standard radiological criteria (i.e., calcifications, dilated pancreatic duct, irregular contour of the gland, or cystic lesions) Endoscopic retrograde cholangiopancreatography exam consistent with chronic pancreatitis by standard radiological criteria (i.e., dilated tortuous main pancreatic duct with irregular secondary branches or intraductal calculi) Endoscopic ultrasound consistent with chronic pancreatitis by standard radiological criteria (i.e., echogenic foci, focal regions of decreased echogenicity, or pancreatic ductal changes)Pancreatic calcifications identified on plain film of the abdomen
- Must have an imaging study of the pancreas within 3 months of study enrollment that does not suggest a pancreatic mass
- Stable clinical history over the past year with no suspicion for cancer due to weight loss, jaundice, or change in abdominal symptoms
- Acute biliary obstruction (stones) including jaundice of benign etiology meeting the following criteria:
- Elevation of serum bilirubin level greater than 2.0 mg/dL
- Dilated extrahepatic biliary systems demonstrated on US, MRI, or CT scan
- Blood sample available within 72 hours of admission and prior to any corrective intervention
- Biliary obstruction must be of benign etiology such as common bile duct stone or benign biliary stricture
- Must have complete imaging study performed of the pancreas that does not suggest a pancreatic cancer (i.e., discrete mass lesion)
- Age, race, and sex-matched to qualified pancreatic cancer cases
Control Participants Exclusion Criteria:
- No family history of pancreatic cancer
- No personal history of acute pancreatitis or biliary obstruction (stones) including jaundice of benign etiology
- No concurrent abdominal pain
- No concurrent unexplained weight loss
Trial locations and contacts
1 site in 1 country.
United States1 site
Eppley Cancer Center, University of Nebraska Medical Center
Omaha, Nebraska, 68198-6805
About this study
Official title: Integrated Cancer Repository for Cancer Research (iCaRe2)- Subproject: Pancreatic Cancer Collaborative Registry
RATIONALE: Gathering information about patients with cancer may help doctors learn more about the disease and plan early diagnosis and treatment.
PURPOSE: This clinical trial is studying computer tools for improving early diagnosis and treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a non-cancerous pancreatic disorder.
Read the detailed description
OBJECTIVES:
- Develop Integrated Biomedical Computing Tools (IBCT) for the better understanding and treatment of pancreatic cancer by using the power of computer and informatics sciences.
- Continue development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure to act as a repository for socio-demographic, environmental, clinical, and family history data collected from individuals and interested family members with a personal and/or family history of pancreatic cancer.
- Participate in an international pancreatic registry known as the PCCR by sharing information collected for research purposes only, to be used by pancreatic cancer research collaborators from other institutions.
- Collect and bank excess biological materials (i.e., pancreatic tissue, tumor tissue, and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue), blood, and serum from registry participants for future research.
OUTLINE: This is a multicenter study.
Patients undergo blood and pancreatic tissue collection. Normal, tumor, and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue from prior surgery or biopsy are obtained.
Patients provide or complete personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures, and re-create their family tree for any cancers that have occurred in any of their family members. Clinical data is collected annually.
High Risk participants provide blood samples and complete questionnaires at baseline. Clinical data is collected annually.
- Conditions
- Pancreatic Cancer
- Being tested
- medical chart review, questionnaire administration, study of socioeconomic and demographic variables, biopsy
- Keywords
- adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
Medical information, called "protected health information" (PHI), which includes demographic information (like address and birth date), the results of physical exams, blood tests, x-rays and other diagnostic and medical procedures and treatments, as well as medical and surgical history will be accessed from the subject's medical record.
questionnaire administrationOther
Provide or complete personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures and to re-create their family tree for any cancers that have occurred in any of their family members. In accordance with OPRR guidelines, no identifying information such as name, address, or date of birth will be used for relatives, but the affected status (cancer, age of onset, age of death) will be recorded. This information will be collected by whichever method they prefer; completing the questionnaires on hardcopy (to then be entered into the PCCR by a data manager) or by logging on to the PCCR website to complete the questionnaires by obtaining a user id and password to enter their information directly into the PCCR. Study participants who are in the EDRN project are required to complete the questionnaires on hardcopy (to then be entered into the PCCR by a data manager).
study of socioeconomic and demographic variablesOther
Share the information they provided with the PCCR research collaborators. This national group has formed the PCCR and is dedicated to pooling their efforts against pancreatic cancer.
biopsyProcedure or surgery
Release a portion of pancreatic tissue, tumor tissue and/or metastatic pancreatic cancer tissue and/or paraffin embedded tissue that has already been collected and saved from their previous surgery or biopsy for storage in the UNMC Solid Tumor Bank for future studies done here or at collaborating institutions. All studies will be proposed in future IRB submissions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data
Ongoing registry.
Measured: Yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startFeb 2003
- Primary completion9 Sep 2013
- Study completion9 Sep 2013
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Quan Ly, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661882
- Sponsor's protocol ID
- 0405-02-FB
- Other IDs
- 5T32CA009476
- Status last verified
- Aug 2023
- First submitted
- 18 Apr 2008
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Cancer Repository for Cancer Research (iCaRe2)- Subproject: Pancreatic Cancer Collaborative Registry
- ClinicalTrials.gov ID
- NCT00661882
- Acronym / sponsor ID
- 0405-02-FB
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2003
- Primary completion
- 9 Sep 2013 (actual)
- Study completion
- 9 Sep 2013 (actual)
- First posted
- 21 Apr 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.
RATIONALE: Gathering information about patients with cancer may help doctors learn more about the disease and plan early diagnosis and treatment.
PURPOSE: This clinical trial is studying computer tools for improving early diagnosis and treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a non-cancerous pancreatic disorder.
Detailed description
OBJECTIVES:
- Develop Integrated Biomedical Computing Tools (IBCT) for the better understanding and treatment of pancreatic cancer by using the power of computer and informatics sciences.
- Continue development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure to act as a repository for socio-demographic, environmental, clinical, and family history data collected from individuals and interested family members with a personal and/or family history of pancreatic cancer.
- Participate in an international pancreatic registry known as the PCCR by sharing information collected for research purposes only, to be used by pancreatic cancer research collaborators from other institutions.
- Collect and bank excess biological materials (i.e., pancreatic tissue, tumor tissue, and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue), blood, and serum from registry participants for future research.
OUTLINE: This is a multicenter study.
Patients undergo blood and pancreatic tissue collection. Normal, tumor, and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue from prior surgery or biopsy are obtained.
Patients provide or complete personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures, and re-create their family tree for any cancers that have occurred in any of their family members. Clinical data is collected annually.
High Risk participants provide blood samples and complete questionnaires at baseline. Clinical data is collected annually.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be asked to voluntarily participate in this project because they have been diagnosed with PC, have a family history of PC, or fulfill the criteria to be one of the three different control groups meaning they will either have a diagnosis of chronic pancreatitis, acute biliary obstruction, or they are a healthy unaffected individual.
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 |
|---|---|---|
| medical chart reviewMedical information, called "protected health information" (PHI), which includes demographic information (like address and birth date), the results of physical exams, blood tests, x-rays and other diagnostic and medical procedures and treatments, as well as medical and surgical history will be accessed from the subject's medical record. | Other | – |
| questionnaire administrationProvide or complete personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures and to re-create their family tree for any cancers that have occurred in any of their family members. In accordance with OPRR guidelines, no identifying information such as name, address, or date of birth will be used for relatives, but the affected status (cancer, age of onset, age of death) will be recorded. This information will be collected by whichever method they prefer; completing the questionnaires on hardcopy (to then be entered into the PCCR by a data manager) or by logging on to the PCCR website to complete the questionnaires by obtaining a user id and password to enter their information directly into the PCCR. Study participants who are in the EDRN project are required to complete the questionnaires on hardcopy (to then be entered into the PCCR by a data manager). | Other | – |
| study of socioeconomic and demographic variablesShare the information they provided with the PCCR research collaborators. This national group has formed the PCCR and is dedicated to pooling their efforts against pancreatic cancer. | Other | – |
| biopsyRelease a portion of pancreatic tissue, tumor tissue and/or metastatic pancreatic cancer tissue and/or paraffin embedded tissue that has already been collected and saved from their previous surgery or biopsy for storage in the UNMC Solid Tumor Bank for future studies done here or at collaborating institutions. All studies will be proposed in future IRB submissions. | Procedure or surgery | – |
Primary outcome
Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data
Time frame: Yearly
Ongoing registry.
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 6 Sep 2023.
- 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. This study is not recruiting at the moment.
Quan Ly, MD principal investigator
University of Nebraska
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 University of Nebraska 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?
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 6 Sep 2023. 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?
Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data (time frame: Yearly). 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 6 Sep 2023.