Clinical trial NCT00661882: Pancreatic Cancer Collaborative Registry
Official title: Integrated Cancer Repository for Cancer Research (iCaRe2)- Subproject: Pancreatic Cancer Collaborative Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-21
Enrollment: 379
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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:

  o 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

Primary outcomes:
measure: Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data
timeFrame: Yearly
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Eppley Cancer Center, University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Quan Ly, MD
role: PRINCIPAL_INVESTIGATOR
References: