NCT00897494

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is examining blood samples from patients with cancer to identify biomarkers that may help in the early detection of pancreatic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

4.8 years

First QC Date

May 9, 2009

Last Update Submit

March 7, 2016

Conditions

Keywords

stage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (2)

  • Identification of specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer

    Upon collection when patient agrees to provide a one time venous blood collection

  • Analysis of serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis

    After separation from the plasma

Interventions

Venous blood collection

Venous blood collection

Venous blood collection

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Venous blood collection samples from newly dianosed

DISEASE CHARACTERISTICS: * Diagnosis of pancreatic cancer * Newly diagnosed disease * Planning to undergo surgery or other treatment for pancreatic cancer at Karmanos Cancer Institute or its affiliates PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Mass SpectrometrySpectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Fazlul Sarkar, MD

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

February 1, 2005

Primary Completion

November 1, 2009

Study Completion

April 1, 2011

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations