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Pancreatic Cancer Genetic Epidemiology (PACGENE) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00526578
Recruitment Status : Active, not recruiting
First Posted : September 10, 2007
Last Update Posted : January 6, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this research study is to investigate the role of genes that may point to a higher risk of developing pancreatic cancer.

Condition or disease Intervention/treatment
Pancreatic Cancer Behavioral: Questionnaire

Detailed Description:

Participants in this study will be part of a pancreatic cancer genetic epidemiology consortium (herein referred to as "PACGENE"), which includes researchers at these institutions: Mayo Clinic; Johns Hopkins University; Creighton University; University of Toronto Mount Sinai Hospital; Dana Farber; and Karmanos Cancer Institute. Participants have either been diagnosed with pancreatic cancer or are family members of pancreatic cancer patients.

Participants will be asked questions by a trained interviewer using an approved questionnaire. The topics will include demographic data (age, race, etc.), exposures, medical history data, family history of cancer and other conditions, and other lifestyle factors. It should take about 30-40 minutes to complete the questionnaire.

Participants in this study will also have about one and a half tablespoons of blood drawn. Blood that is collected will only be used by researchers involved in this study. If obtaining a blood sample is not possible, the study staff will ask for a saliva sample using an ORAGENE kit. Neither participants nor their physicians will receive individual reports of this research. Results will not be placed in the participant's health records. All information will be kept confidential and used only for this research.

There is a rare chance that a research team member could be accidentally exposed to your blood or body fluids. If that occurs, extra blood (about 2 teaspoons) may be drawn to test for infections such as hepatitis and HIV (the AIDS virus). An existing blood sample may be used for these tests instead. You will be told that your blood is being tested and the results of your test. Researchers will ask how you would like to receive the results, such as by phone or certified letter. The test results and your name, address, date of birth, and sex will be recorded in the confidential M. D. Anderson medical records.

If you test positive for hepatitis or HIV, the test results and your name, address, date of birth, and sex will be shared with appropriate health authorities as required by law. You will also be given a list of places in your area so that you can receive further testing and treatment.

For the protection of your privacy, the study staff has obtained a Certificate of Confidentiality from the National Institutes of Health. With this certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the certificate to resist any demands for information that would identify you, except as explained below.

The certificate cannot be used to resist a demand for information from personnel of the United State Government that is used for auditing or evaluation of Federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the certificate to withhold that information.

This is an investigational study. This study will include a total of 1,000 participants recruited at M. D. Anderson.

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Study Type : Observational
Estimated Enrollment : 4770 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pancreatic Cancer Genetic Epidemiology (PACGENE) Study
Actual Study Start Date : June 19, 2002
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Pancreatic cancer patients or family member.
Behavioral: Questionnaire
Questionnaire taking about 30-40 minutes to complete.
Other Name: Survey

Primary Outcome Measures :
  1. Identification of susceptibility genes in high risk familial pancreatic cancer (FPC) pedigrees using cutting-edge genetic analysis methods [ Time Frame: 8 Years ]
    Data collection from patient response to 30-40 minute questionnaire and blood test.

Biospecimen Retention:   Samples With DNA
Blood sample will be collected.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
MDACC pancreatic cancer patients and family members (two or more) of someone with pancreatic cancer, all over over the age of 18.

Inclusion Criteria:

1) An effected or uneffected member of a family, age 18 or older, that has two or more reported pancreatic cancers in the family.

Exclusion Criteria:

  1. Cases under age 18.
  2. Relatives of pancreatic cancer cases under age 18.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00526578

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Carrie Daniel-MacDougall, PHD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00526578    
Other Study ID Numbers: ID02-139
1R01CA097075-01 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Pancreatic Cancer
Pancreatic Cancer Genetic Epidemiology
Healthy Control
Familial Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases