Mayo Clinic researchers have demonstrated that a noninvasive screening test can detect not only colorectal cancer but also the common cancers above the colon — including pancreas, stomach, biliary and esophageal cancers. This is one of more than 100 Mayo Clinic studies presented at Digestive Disease Week 2009 in Chicago, May 30–June 4.
“Patients are often worried about invasive tests like colonoscopies, and yet these tests have been the key to early cancer detection and prevention,” says David Ahlquist, M.D., Mayo Clinic gastroenterologist and lead researcher on the study. “Our research team continues to look for more patient-friendly tests with expanded value, and this new study reveals an opportunity for multi-organ digestive cancer screening with a single noninvasive test.”
The researchers studied 70 patients with cancers throughout the digestive tract. Besides colon cancer, the study looked at throat, esophagus, stomach, pancreatic, bile duct, gallbladder and small bowel cancers to determine if gene mutations could be detected in stool samples. Using a stool test approach developed at Mayo Clinic, researchers targeted DNA from cells that are shed continuously from the surface of these cancers. Also studied were 70 healthy patients. Stool tests were performed on cancer patients and healthy controls by technicians unaware of sample source. The stool DNA test was positive in over 70 percent of digestive cancers, but remained negative for all healthy controls, thus demonstrating the approach’s feasibility.
Stool DNA testing detected cancers at each organ site, including 65 percent of esophageal cancers, 62 percent of pancreatic cancers, and 75 percent of bile duct and gallbladder cancers. In this series, 100 percent of both stomach and colorectal cancers were detected. Importantly, stool test results did not differ by cancer stage; early-stage cancers were just as likely to be detected as late-stage cancers.
“It’s very exciting to see this level of sensitivity for digestive cancer detection in our first look at this test application,” says Dr. Ahlquist, “Historically, we’ve approached cancer screening one organ at a time. Stool DNA testing could shift the strategy of cancer screening to multi-organ, whole-patient testing and could also open the door to early detection of cancers above the colon which are currently not screened. The potential impact of this evolution could be enormous.”
Below is a link to an edited youtube video with Dr. Ahlquist.
What is the availability of DNA stool testing? Can I ask my doctor to provide one? I ask because I have elevated CEA (11) although a colonscopy and CT scan found no evidence of tumors or polyps.
We are actively continuing this research to fulfill our professional obligation to see that patients will benefit from such a test approach. Timing of clinical tests will depend on regulatory approvals and commercialization efforts. Meanwhile, we encourage patients to discuss existing screening options with their health care provider.
Mayo Clinic Public Affairs
What is the name or number of the DNA
Stool?
Is the test Available at this time
Thank You
Fred Sweet
Thank you for your question. Exact Sciences has licensed Mayo technology related to stool DNA testing, and Exact plans to conduct additional studies required to obtain FDA approvals (http://phx.corporate-ir.net/phoenix.zhtml?c=125466&p=irol-newsArticle&ID=1298527&highlight=). We hope that a commercial product will be available soon after FDA approval has been granted.
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Is there any update on how soon the FDA approval might occur?
Here is a recent interview on the story for your reference:
http://wcco.com/health/colon.cancer.prevention.2.1690019.html
It may be another year before the test is available at Mayo Clinic.
Thank you.
I would like to know if the DNA stool testing is available at Mayo Clinic at this time.
I’m checking on your question; the last time I checked it still was not.
thanks. I do not want to go under a drug for colonoscopy and want to use the dna stool testing method. Are any further research programs in use that I can volunteer to be part of I would be interested.
Edie
Is the DNA stool test available yet at Mayo Clinic? Can an elevated CEA level originate in the digestive system before the colon or is the colonrectal area the only place where CEA can be found or detected?
When do you expect fda approval for the dna stool test for colon cancer? Does the fda offer opportunity for members of the public to comment during their approval process? Thanks.
We have received your questions and are looking into an answer.
I would love to be part of the trial for use of this test. Is it too late to get involved? If not, how do I go about getting on the list?
Thank you for your note. I will check to see if it is still possible to be part of this trial and get back to you.
Your question has been referred to a study coordinator for a reply.
I would be interested in being in the trial study also.
Where can I have a DNA stool sample to see if I have colon cancer?
We’re checking on an answer.
We’re awaiting FDA approval. Test should be available in 2013.
I have had a colonoscopy and a cancerous polyp was found. During the colonoscopy, the colon was damaged, causing me now to live with a damaged colon and am afraid to have followup tests for fear of more damage. I would be very interested in the DNA stool testing when it becomes available.
We’re awaiting FDA approval. The test should be available in 2013.
wow what a great advancement, congratulations! i would love to be apart of the clinical trial also. please let me know who i can contact for more information. thank you!
I would like the opportunity to talk to Dr. Ahlquist about extending his research to another remote island of Yupik natives. The level of cancer is thought by residents of Saint Lawrence Island (part of Alaska, but 40 miles off of Siberia) to be very high on the island due to PCBs and other contaminants left on the island by the military during the cold war. Better testing is needed in this remote location to determine if the levels of cancer are truly higher and if so, how to provide methods for early detection.
Your comment has been forwarded to Dr. Ahlquist.
This is wonderful! The DNA stool test sounds like a very good alternative for those of us who have other health issues in which the traditional colonoscopy might be contraindicated. Will health insurance pay for the test, if not, how expensive is it?
Gail,
While the DNA stool test appears to hold much promise, it’s not ready for prime time. Dr. Ahlquist continues his research and we hope for more information in the coming months.
I had a colonoscopy 10 years ago and a cancerous polyp was found. During the colonoscopy, the colon was damaged, causing me now to live with a damaged colon. I have been having symptoms that are not good, but am afraid to have the follow-up colonoscopy for fear of more damage. If there is a trial going on in the Phoenix area, I would be very interested. Any information would be greatly appreciated. Thank you!
If participants are still needed, I would very much like to be a part of this trial.
Would a person who was diagnosed with gall bladder cancer & it was removed June 10,2012, and not given cemo or radiation therapy, just instructed to have a Cat scan every 6 mos. be useful in a trial such as this, to detect reocurance in the digestive tract?
This DNA testing sounds like a wonderful advancement.
Is there a committee in the FDA persons could contact to influence
a commiment of funds to further Dr. Alquists’ testing?
Hello and thank you for your question. We will contact the study coordinator to find out if the study is still open and get back to you with a response. Thanks again!
We heard back from Dr. Ahlquist and here is his response to you: “We appreciate your supportive comments. You would not be eligible for any current study. However, the test may be beneficial to you when it becomes available. Thanks, Dr. Ahlquist.”
My father was diagnosed and treated for colon cancer (by colon resection) when he was 58. He is now 90. As such, I am in the high risk group for colon cancer. I had my first colonoscopy when I was 43, and it came up negative. I am now 53 and due for a second test. Considering how uncomfortable and inconvenient was the first test, this new alternative is clearly preferred. Since we moved to Switzerland some six years ago, I would like to know if the test is somehow available here or in Europe? Or is FDA approval still required?
Thank you for your comment. We are checking into your questions.
The stool DNA test is expected to be approved by FDA by mid 2013, and it should be available at Mayo and other labs soon after. Discussions are underway to consider distribution in Europe. Alternatively, it may be possible to send stool samples by mail to US for testing. We should have definitive answers to these questions by late 2013.
I was diagnosed with Stage 3 colon cancer in 1988. In 3/13 I had 22 polyps removed, 15 adenomas. Given that the colon microbiome has been implicated in colon cancer, are any labs doing stool-based DNA screening for the taxonomic composition and metabolic capacity of the microbiota. Thank you. George F Bazinet, Jr. PhD
I was diagnosed with Stage 3 colon-rectal cancer in 1988. In March 2013 my colonoscopy revealed 22 polyps, 15 of which were adenomas. Given that the colon microbiome has been implicated in colon cancer, are any labs doing stool-based DNA screening for the taxonomic composition and metabolic capacity of the microbiota?
George, We will forward your questions on for possible response. Thank you.