Pancreatic Cancer Collaborative Registry

NCT00661882 | Completed

• 2 other identifiers: 0405-02-FB5T32CA009476
• Study Type: observational
• Target: 379
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data

  Ongoing registry.

  Yearly

Interventions

medical chart review OTHER

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 administration OTHER

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 variables OTHER

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.

biopsy PROCEDURE

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.

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• No prior malignancy, except nonmelanoma skin cancer, for 10 years
• No prior preoperative chemoradiotherapy (neoadjuvant)
• 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
• No family history of pancreatic cancer

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Eppley Cancer Center, University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Questionnaire Blood: 30ml Access to leftover tissue: release a portion of leftover tissue collected and saved from surgery/biopsy.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Quan Ly, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 21, 2008
• Study Start: February 1, 2003
• Primary Completion: September 9, 2013
• Study Completion: September 9, 2013
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)