Pancreatic Cancer Genetic Epidemiology (PACGENE) Study

January 3, 2020 updated by: M.D. Anderson Cancer Center
The goal of this research study is to investigate the role of genes that may point to a higher risk of developing pancreatic cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

4770

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Carrie Daniel-MacDougall, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2002

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Actual)

January 6, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID02-139
  • 1R01CA097075-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe