See if you qualify to participate in this research study that uses your blood sample to determine how well our new experimental technology can help in the early detection of cancer.
Healthy 1000 Clinical Research Study
Pathway Genomics® has developed a new experimental blood test (CancerIntercept™ Detect) to identify mutations in genes that are associated with the development and progression of cancer.
This Healthy 1000 Clinical Research Study analyzes blood samples from participants who have never been diagnosed with cancer and, at present, show no symptoms of cancer. Each enrolled participant is considered at high risk for cancer based on age, family history, genetics, or certain environmental exposures.
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What is the purpose of this clinical research study?
The objective of this research study is to obtain human blood samples from asymptomatic subjects who have never been diagnosed with cancer, but who are at higher risk for cancer based on age, family history, genetic predisposition, or environmental exposure. The blood samples will be used to do research on whether or not molecular genetic assays are able to detect cancer at an early stage.
Clinical study background
The cells of your body contain a molecule called DNA. Small parts of the DNA, called genes, give you certain traits like eye color and hair color. Other genes affect your chances of getting certain diseases or the way your body reacts to medicines (drugs). When a cancer develops inside of a human, the DNA in the cancer cells become modified with alterations that are not inherited from your parents. These alterations are called somatic mutations. Specific somatic mutations have been found in many cancers. The cancer cells shed DNA (cell-free DNA or cfDNA) into the blood stream, which may allow the use of a blood sample to find undiagnosed cancer. The DNA from tumors that is found in the blood is called circulating tumor DNA or ctDNA.
This research study involves analyzing selected variants (mutations) in genes known to be associated with the formation of specific types of cancer from human blood specimens in order to support the detection of these mutations in the blood of otherwise asymptomatic individuals.
Who can participate?
In order to participate in this study, you must be:
- 18 years of age or older
- Have legal authority to provide consent, under applicable laws
- Prior to this study have never been diagnosed with cancer (except for basal cell carcinomas of the skin)
- Considered to be at an increased risk for the development of cancer based on the following criteria:
- You must be either over the age of 50, or
- If between 18-50 years old, be at a known increased risk for breast, ovarian, colon, lung, pancreatic, or thyroid cancers, or melanoma. Examples are:
- i. you are a BRCA1/2 carrier,
- ii. you have HNPCC or FAP,
- iii. you have Li Fraumeni Syndrome,
- iv. you have been a long time smoker,
- v. or you have a strong family history of the above cancers.
What can I expect?
If you choose to participate in this study, you will be asked to fill out the health questionnaire to assess your eligibility for participation. You should ask for help from your primary care physician if you need additional information in order to answer the questions.
Should you be eligible for entry into the study, you may have your blood drawn by your primary care physician or Pathway Genomics will provide a licensed phlebotomist who will meet you and will collect 30 milliliters (ml) (approximately 2 tablespoons) of your blood. You will not be asked to provide more than 30 ml of blood in any day and should we request a second sample, no more than another 30 ml will be obtained. The phlebotomist or your physician will return your sample to Pathway Genomics’ laboratory (in person or by mail using the provided package and pre-paid shipping label). Follow-up surveillance by the subject’s personal healthcare provider will continue as indicated by the current standards of care and guidelines for age and gender.
It is not the purpose of this study to provide you with a medical or genetic diagnosis. If you choose, you will be told the findings of any of the analyses done on your specimen(s). Prior to notifying you, we will notify your primary care provider about the results and provide that provider with the opportunity to speak to an oncologist to help with the interpretation of any positive result.
What will I learn by participating?
The goal of the study is to contribute to medical research. This test is still experimental. However, the study test may find mutations in the genes in your blood that may indicate the need for medical follow-up. We will require that you give us the name and contact information of your personal physician or healthcare provider in order to inform him or her if the study test detects mutations indicating that you are at increased risk of developing cancer. If you wish not to know the study test results (whether positive or negative for mutations), please tell this to the physician or healthcare provider whose contact information you provide to us.
You may not receive any direct medical benefit from participating in this study. This test is not designed to diagnose cancer, but may help in the early detection of some types of cancer. The information obtained from this study may help society by fostering the development of new assays. Should this screening test prove a viable method for helping a healthcare provider detect cancer in a patient at risk for cancer, society will potentially benefit by earlier detection of cancer at a more treatable stage.
Interested in participating?
This is what you need to know to enroll: