Trial designed to better understand link between pancreatic cancer, newly diagnosed diabetes

Richard Frank

A new trial has been launched to help researchers better understand the link between new-onset diabetes and pancreatic cancer.

Researchers also hope to identify biomarkers that may allow for earlier detection of pancreatic cancer among individuals with newly diagnosed diabetes.

“The idea for the study came from an increasing appreciation of the link between diabetes and pancreatic cancer in those older than 50 years of age,” Richard Frank, MD, director of clinical cancer research for Western Connecticut Health Network, said in a press release. “In particular, new-onset diabetes is estimated to carry a sevenfold increased risk for pancreatic cancer during the first 3 years after a diagnosis of diabetes. This gives us the opportunity to attempt to detect pancreatic cancer at a very early stage.”

Participants in the $2.7 million, 3-year trial will undergo annual MRI of the pancreas. Endoscopic ultrasound will be used to investigate suspicious lesions for the presence of cancer or precancerous changes.

Investigators will collect blood samples every 6 months, which will be added to a serum biobank in hopes of determining the earliest signs of pancreatic cancer at the DNA level.

HemOnc Today spoke with Frank and Ronald Lee, MD, chair of the department of radiology at Norwalk Hospital in Connecticut, about the trial and the insights it may provide.

Question: What prompted this research?

Frank: On a personal level, I have grown close to patients with pancreatic cancer and have become more affected by the devastation of this disease. We are seeing more of it, and in a younger population of patients. Yet, we are seeing little progress in research and treatment. Pancreatic cancer requires true scientific breakthroughs, and because this does not seem to be coming soon, I decided to look into screening for these patients.

Q: Can you describe the connection between diabetes and pancreatic cancer?

Frank: Research around the world has been performed on high-risk groups. Familial or genetic risk groups have become easier to identify, but they only account for 5% of pancreatic cancers. Because this is not really the target population we commonly see, I started to look at the sporadic population of patients to identify who could be targeted. Many experts have called for a screening study in those with new-onset diabetes, because a significant fraction of individuals diagnosed with pancreatic cancer have been diagnosed with diabetes in the 2 to 3 years prior to their cancer diagnosis. We have developed our own criteria for dealing with the issues of unconfirmed new-onset diabetes and prediabetes, which is prevalent.

Lee: Pancreatic cancer has a poor prognosis, with a 5-year survival between 7% and 8%. However, if we are able to catch it early and the patient undergoes surgery, the 5-year survival increases by about 20%. When looking at available screening modalities, the sensitivity of ultrasound is too low. CT scan is decent, but MRI is much better. Endoscopic ultrasound is more sensitive, but it is invasive. In selecting a screening study, we want to choose a method that is not invasive and not too costly. The literature seems to point to MRI as the optimal screening tool. We were trying to push the envelope and do high-resolution MRI imaging to detect the disease earlier in patients with newly diagnosed diabetes.

Q: How will you gather the data?

Frank: Study sites are Danbury Hospital, Norwalk Hospital and New Milford Hospital, all of which are in Connecticut. We will reach out to primary care physicians in our community and around the state, visit their practices and generate enthusiasm about our study. We are relying on referrals from primary care physicians, not only within our health care system, but also from regional hospitals. We will seek referrals via word-of-mouth, electronic medical record data searches and mailed letters to gather our cohort.

Q: How can someone participate?

Frank: Patients or physicians who wish to refer patients may contact Tammy Lo, APRN, by calling (203) 855-3551 or emailing her at tammy.lo@wchn.org. She will meet with patients every 6 months and schedule blood draws for the biobank, administration of a brief psychosocial survey and annual MRI/magnetic resonance cholangiopancreatography.

Q: When do you hope to have results?

Frank: We hope to screen 800 individuals aged 50 years or older with new-onset diabetes within the next 3 to 5 years and start to understand if the detection rate is in line with the expected rate, which is approximately 1 in 100 patients. If we can accrue roughly 100 patients within the first year of the study and report on what we are finding, this will be the first set of data. However, the timeline depends on referrals from physicians.

Q: What additional insights into the diabetes pancreatic cancer link do you hope to uncover?

Frank: The goal is to distinguish those individuals with new-onset diabetes who are at high risk for pancreatic cancer from the far greater number of individuals with new-onset diabetes who never develop pancreatic cancer. We will gather a lot of demographic data and family history information from patients. We also will look at quality-of-life issues and standard risk factors, such as smoking status, alcohol use and physical activity. I hope to eventually have a biobank that can be used by other researchers who feel they have a biomarker for pancreatic cancer–associated diabetes. Several groups think they have biomarkers, and if we could have a biobank of these patients for the community to work from, I would be happy to provide this. The primary goal for everyone would be to find the biomarker to screen the high-risk group and then put only this group through imaging. – by Jennifer Southall

For more information:

Richard Frank, MD, can be reached at Norwalk Hospital, 34 Maple St., Norwalk, CT 06851; email: richard.frank@wchn.org.

Ronald Lee, MD, can be reached at Norwalk Hospital, 34 Maple St., Norwalk, CT 06851; email: ronald.lee@wchn.org.

Disclosure: Frank and Lee report no relevant financial disclosures.

Richard Frank

A new trial has been launched to help researchers better understand the link between new-onset diabetes and pancreatic cancer.

Researchers also hope to identify biomarkers that may allow for earlier detection of pancreatic cancer among individuals with newly diagnosed diabetes.

“The idea for the study came from an increasing appreciation of the link between diabetes and pancreatic cancer in those older than 50 years of age,” Richard Frank, MD, director of clinical cancer research for Western Connecticut Health Network, said in a press release. “In particular, new-onset diabetes is estimated to carry a sevenfold increased risk for pancreatic cancer during the first 3 years after a diagnosis of diabetes. This gives us the opportunity to attempt to detect pancreatic cancer at a very early stage.”

Participants in the $2.7 million, 3-year trial will undergo annual MRI of the pancreas. Endoscopic ultrasound will be used to investigate suspicious lesions for the presence of cancer or precancerous changes.

Investigators will collect blood samples every 6 months, which will be added to a serum biobank in hopes of determining the earliest signs of pancreatic cancer at the DNA level.

HemOnc Today spoke with Frank and Ronald Lee, MD, chair of the department of radiology at Norwalk Hospital in Connecticut, about the trial and the insights it may provide.

Question: What prompted this research?

Frank: On a personal level, I have grown close to patients with pancreatic cancer and have become more affected by the devastation of this disease. We are seeing more of it, and in a younger population of patients. Yet, we are seeing little progress in research and treatment. Pancreatic cancer requires true scientific breakthroughs, and because this does not seem to be coming soon, I decided to look into screening for these patients.

Q: Can you describe the connection between diabetes and pancreatic cancer?

Frank: Research around the world has been performed on high-risk groups. Familial or genetic risk groups have become easier to identify, but they only account for 5% of pancreatic cancers. Because this is not really the target population we commonly see, I started to look at the sporadic population of patients to identify who could be targeted. Many experts have called for a screening study in those with new-onset diabetes, because a significant fraction of individuals diagnosed with pancreatic cancer have been diagnosed with diabetes in the 2 to 3 years prior to their cancer diagnosis. We have developed our own criteria for dealing with the issues of unconfirmed new-onset diabetes and prediabetes, which is prevalent.

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Lee: Pancreatic cancer has a poor prognosis, with a 5-year survival between 7% and 8%. However, if we are able to catch it early and the patient undergoes surgery, the 5-year survival increases by about 20%. When looking at available screening modalities, the sensitivity of ultrasound is too low. CT scan is decent, but MRI is much better. Endoscopic ultrasound is more sensitive, but it is invasive. In selecting a screening study, we want to choose a method that is not invasive and not too costly. The literature seems to point to MRI as the optimal screening tool. We were trying to push the envelope and do high-resolution MRI imaging to detect the disease earlier in patients with newly diagnosed diabetes.

Q: How will you gather the data?

Frank: Study sites are Danbury Hospital, Norwalk Hospital and New Milford Hospital, all of which are in Connecticut. We will reach out to primary care physicians in our community and around the state, visit their practices and generate enthusiasm about our study. We are relying on referrals from primary care physicians, not only within our health care system, but also from regional hospitals. We will seek referrals via word-of-mouth, electronic medical record data searches and mailed letters to gather our cohort.

Q: How can someone participate?

Frank: Patients or physicians who wish to refer patients may contact Tammy Lo, APRN, by calling (203) 855-3551 or emailing her at tammy.lo@wchn.org. She will meet with patients every 6 months and schedule blood draws for the biobank, administration of a brief psychosocial survey and annual MRI/magnetic resonance cholangiopancreatography.

Q: When do you hope to have results?

Frank: We hope to screen 800 individuals aged 50 years or older with new-onset diabetes within the next 3 to 5 years and start to understand if the detection rate is in line with the expected rate, which is approximately 1 in 100 patients. If we can accrue roughly 100 patients within the first year of the study and report on what we are finding, this will be the first set of data. However, the timeline depends on referrals from physicians.

Q: What additional insights into the diabetes pancreatic cancer link do you hope to uncover?

Frank: The goal is to distinguish those individuals with new-onset diabetes who are at high risk for pancreatic cancer from the far greater number of individuals with new-onset diabetes who never develop pancreatic cancer. We will gather a lot of demographic data and family history information from patients. We also will look at quality-of-life issues and standard risk factors, such as smoking status, alcohol use and physical activity. I hope to eventually have a biobank that can be used by other researchers who feel they have a biomarker for pancreatic cancer–associated diabetes. Several groups think they have biomarkers, and if we could have a biobank of these patients for the community to work from, I would be happy to provide this. The primary goal for everyone would be to find the biomarker to screen the high-risk group and then put only this group through imaging. – by Jennifer Southall

For more information:

Richard Frank, MD, can be reached at Norwalk Hospital, 34 Maple St., Norwalk, CT 06851; email: richard.frank@wchn.org.

Ronald Lee, MD, can be reached at Norwalk Hospital, 34 Maple St., Norwalk, CT 06851; email: ronald.lee@wchn.org.

Disclosure: Frank and Lee report no relevant financial disclosures.