Novel Surveillance Strategies
Novel Surveillance Strategies for Hereditary Non-Polyposis Colon Cancer Family Members
Currently, annual colonoscopy is the only way to detect the presence of precancerous polyps. The novel surveillance strategies study will allow for early detection of pre-malignant colon neoplasms in HNPCC family members through alternate means of testing. This study is being done to see if substances called molecular markers from blood, stool, and colon tissue can be used to improve our ability to detect pre-malignant colon neoplasms in HNPCC families.
GOAL OF THE STUDY:
The goal of this study is to examine novel (new) surveillance strategies by looking at changes in blood, stool, and tissue that may improve the surveillance and early detection for colon cancer in people with Hereditary Non-Polyposis Colorectal Cancer (HNPCC).
WHAT IS INVOLVED?
The study requires the following:
A stool sample before your annual colonscopy.
- Donation of three 10cc (6 teaspoons) of blood at the time of your annual colonoscopy.
- Permission to obtain samples of any tissue removed by biopsy or surgery before this study started and during any scheduled colonoscopy or surgery during the study.
Information collected about you in relation to this study such as medical history, results of your blood tests, and medical tests, reports from any surgery, reports of your office visits, and your treatments, and other confidential information from your medical records.
This research may result in the development of new findings about HNPCC, its treatment, prevention, and possible cure. Research by Creighton University and collaboration institutions using your information, blood, stool, and/or tissue may benefit you or your family members. Participation in the study may produce information that may be helpful to you or your relatives in diagnosing or treating HNPCC.
You will not be compensated for participating in this study and we will not pay for your hospital or procedure-related charges, including your surveillance colonoscopy and related procedure. There will be no cost to you for participation in the study, including providing the blood sample and stool sample. Research using your blood, stool, and tissue samples may lead to the development of new products with commercial value. These products might include cells for research, medicines, or other treatments. You will not be paid if new products are developed from this research.
You may be eligible for this study if:
- You and/or other members in your family have already been identified as being at risk for colon cancer due to an inherited mutation called Hereditary Non-Polyposis Colon Cancer (HNPCC) or have an unusually large number of colon cancers in your family.
- Undergo an annual colonoscopy or flex-sigmoidoscopy
If you are interested in participating or would like more information, please contact us at 1(800)648-8133 ext. 2942.
Phenotypic and Psychosocial Study of the I1307K Mutation
Several genetic mutations that cause hereditary colorectal cancer have been identified. One of these is the I1307K mutation in the APC gene, discovered in 1997. This mutation is thought to double the risk for colorectal cancer over one’s lifetime. The APC I1307K mutation has been identified in 6% of Ashkenazi Jews, 10% of Ashkenazim with a history of colorectal cancer (CRC), and 28% of Ashkenazim who have both CRC and a family history of CRC.
GOAL OF THE STUDY:
The goal of this study is to learn more about the effects of the I1307K mutation, identify the most effective regimen for cancer screening, evaluate the psychological impact of genetic testing for the I1307K mutation and examine the processes of coping with genetic information.
WHAT IS INVOLVED?
A blood draw is the only medical procedure involved for the genetic testing to be performed.
Some individuals believe that the relief from the uncertainty about their gene status is preferable no matter what their result.
If you choose to share your genetic test result with other individuals in your family, they may learn important information about their risk for CRC based on your results, providing them an opportunity to seek counseling, genetic testing, and/or recommendations for cancer surveillance.
There is no cost to you for giving blood or tissue samples, having genetic testing performed, receiving genetic results, or receiving genetic counseling.
The costs of cancer surveillance and prevention measures such as colonoscopy outside of this study or prophylactic surgery are not covered by this research study.
You may be eligible for the study if you:
Are of Ashkenazi heritage with a personal history of colon cancer.
Are of Ashkenazi heritage with no personal history of colon cancer, but have a first degree relative who died of colon cancer and whose tissue samples may be obtained for genetic testing
If you are interested in participating or would like more information, please contact at 1-800-648-8133 1-800-648-8133 1-800-648-8133 1-800-648-8133 , ext. 2942.