NCT00100321

Brief Summary

This study will examine pancreatic tumor tissue and immune cells from patients with a pancreatic tumor to look for markers on these cells that may be useful in developing new treatments for the disease. Patients 16 years of age and older with any evidence of a primary pancreatic tumor that can be surgically removed may be eligible for this study. Types of pancreatic tumors included in this trial are pancreatic cancer, adenosquamous carcinoma, anaplastic carcinoma, IPMN (intraductal pancreatic mucinous neoplasm), acinar cell carcinoma, pancreaticoblastoma, mucinous cystic neoplasms, serous cystic neoplasms, solid-pseudopapillary cystic neoplasms, squamous cell carcinoma, Vater (ampullary tumors) duodenal adenoma or cancer and common bile duct tumors (cholangiocarcinoma.) The specific type of tumor does not have to be determined before the operation. Candidates are screened with a medical history and physical examination, computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis, blood and urine tests, and an electrocardiogram. Patients older than 50 years of age and patients with a history of cardiovascular disease may also have a thallium cardiac stress test. Participants undergo standard treatment for their pancreatic tumor, including surgery to remove the tumor. Before, during, and after the operation, several blood samples are drawn as part of routine patient care and for research tests. During the surgery, a small piece of tumor tissue is taken for examination under the microscope and to grow cells in the laboratory for tumor and immune cell studies. Some patients may undergo leukapheresis to collect large numbers of white blood cells for study. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are extracted and the rest of the blood (plasma, red cells, and platelets) is returned through another needle in the other arm. Patients who require additional treatment, such as chemotherapy or radiation, may be treated at NIH on another protocol or referred for appropriate treatment elsewhere.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2004

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2004

Completed
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2012

Completed
Last Updated

December 17, 2019

Status Verified

November 20, 2012

First QC Date

December 28, 2004

Last Update Submit

December 14, 2019

Conditions

Pancreatic Neoplasms

Keywords

Tumor Antigen IdentificationStandard TreatmentTissue AcquisitionSurgeryAdjuvant ChemotherapyPancreatic CancerPancreatic Tumor

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient greater than or equal to 16 years of age with radiographic or endoscopic evidence of a pancreatic mass, ampullary mass or malignant stricture without evidence of distant metastases.
  • Recovered from any serious toxicity experienced during previous treatment (chemo-, radiation, hormone, immuno-, etc., therapy) for pancreas cancer to a grade 2 or less.
  • ECOG Performance Status greater 0-2.
  • Must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26. doi: 10.3322/canjclin.53.1.5.

    PMID: 12568441BACKGROUND

  • Parkin DM, Bray FI, Devesa SS. Cancer burden in the year 2000. The global picture. Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66. doi: 10.1016/s0959-8049(01)00267-2. No abstract available.

    PMID: 11602373BACKGROUND

  • Abbruzzese JL. New applications of gemcitabine and future directions in the management of pancreatic cancer. Cancer. 2002 Aug 15;95(4 Suppl):941-5. doi: 10.1002/cncr.10753.

    PMID: 12209675BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Udo Rudloff, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 28, 2004

First Posted

December 29, 2004

Study Start

December 21, 2004

Study Completion

November 20, 2012

Last Updated

December 17, 2019

Record last verified: 2012-11-20

Locations

US(1)