Clinical trial evaluates T-cell therapy for advanced mesothelin-expressing cancers

Killer T cells therapy for advanced mesothelin expressing cancer

Superresolution image of a group of killer T cells (green and red) surrounding a cancer cell (blue, center). Photo courtesy of NCI Visuals Online

Patients with advanced mesothelin-expressing solid tumors may be eligible to participate in a new clinical trial at the NIH Clinical Center.

Mesothelin is a protein found on the surface of normal, healthy cells that may help the cells stick together and send signals. Some cancer cells express a higher-than-normal amount of mesothelin, which makes them more likely to multiply and spread to other parts of the body. Raffit Hassan, M.D., of the Thoracic and GI Malignancies Branch, is leading a trial that tests T-cell immunotherapy for patients with cancer of the lung and its lining, ovarian cancer and bile duct cancer that express high levels of mesothelin. This therapy harnesses a patient’s T cells, altered to recognize mesothelin, with the aim of attacking cancer cells.  For more information about this and more clinical trials, click here.



New Onset Diabetes Cohort Sought to Unravel Complexities of Pancreatic Cancer Development

Tuesday, November 19, 2019, by DCP Staff

Studying link between diabetes and pancreatic cancer

About 1 in 100 people with new onset diabetes are diagnosed with pancreatic cancer within 3 years of their diabetes diagnosis; 1 in 4 people diagnosed with pancreatic cancer were first diagnosed with diabetes.

About 1 in 100 people with new onset diabetes are diagnosed with pancreatic cancer within 3 years of their diabetes diagnosis; 1 in 4 people diagnosed with pancreatic cancer were first diagnosed with diabetes.

The National Cancer Institute is leading a project to create a cohort of people who are newly diagnosed with diabetes in the hopes that this group, who are at increased risk of developing pancreatic cancer, provide the clues in their blood and tissues to unravel some of the unknowns about this highly fatal cancer. The New Onset Diabetes Study (NOD) will include 10,000 people ages 50 to 85 across the United States.

Diabetes is a disease that occurs when your blood glucose is too high. The hormone insulin, made by the pancreas, is responsible for regulating blood glucose, so having diabetes signals a problem with the pancreas.

NCI, in partnership with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), funded the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (CPDPC). The NOD study is a critical part of this project to gain insight into the pathophysiology of chronic pancreatitis and its associated illnesses: chronic pain, pancreatic insufficiency, Type 3c diabetes and the diabetes/pancreatic cancer association. The multidisciplinary teams are also studying the development of pancreatic cancer in newly diagnosed diabetic patients.

Over 90% of pancreatic cancer is sporadic, meaning it occurs in people without a family history of the disease. It is both relatively rare (about 3% of cancers diagnosed in the U.S.) and very deadly (fewer than 10% of those diagnosed live more than 5 years). There is no identifiable high-risk group for sporadic pancreatic cancer, few high-quality biospecimens are available to conduct tests of biomarkers, there are few biomarkers of early detection to test, and no imaging techniques to find pancreatic cancer early in its development. Finding ways to identify this cancer early is critical to learning how to prevent it and to be able to treat it in earlier stages.

People who are over age 50 who recently developed diabetes (referred to as new onset diabetes) are at higher risk of being diagnosed with pancreatic cancer within three years of being diagnosed with diabetes (compared to those without diabetes). One study determined that within three years of being diagnosed with diabetes, 85 out of 100,000 (0.85%) people will be diagnosed with pancreatic cancer. This number may seem small, but that less than 1% of people with diabetes represents one quarter of all patients with pancreatic cancer.

An estimated 30.3 million adults in the United States have diabetes (9.4% of the US population), and while 23.1 million know their diagnosis, another 7.2 million are not yet diagnosed. About 84.1 million adults—about 1 in 3—have prediabetes, which usually occurs in people who already have some insulin resistance or whose beta cells in the pancreas aren’t making enough insulin to keep blood glucose in the normal range. These people have a 50% chance of developing diabetes over the next 5 to 10 years. The information gained from NOD could benefit these people.

“NOD will play an important role in addressing these challenges,” said Jo Ann Rinaudo, PhD, a program director in the NCI DCP Cancer Biomarkers Research Group who is involved in NOD. This prospective cohort of subjects >50 and ≤85 years of age with new onset diabetes (NOD) is being recruited, with the goals of:

  • Estimating the probability of pancreatic cancer in the NOD Cohort;
  • Establishing a biobank of clinically annotated biospecimens;
  • Facilitating validation of emerging tests for identifying NOD subjects at high risk for having pancreatic cancer using the clinically annotated biospecimen reference set; and
  • Providing a platform for the future development of an early detection protocol for sporadic pancreatic cancer in New Onset Diabetes subjects that incorporates imaging and clinical parameters.

The NCI Community Oncology Research Program (NCORP) is participating in creating the cohort, via Community Sites in California, Michigan, and Washington.

The CPDPC is holding their Biannual meeting in Bethesda, MD on December 9-10, 2019.


  • 84.1 million adults have prediabetes. 1 in 2 (42 million) of them will become diabetic within 10 years.
  • 30.3 million adults in the US have diabetes. 1 in 1,000 will be diagnosed with pancreatic cancer in 3 years.
  • Of the 56,770 new cases of pancreatic cancer in the U.S. in 2019, at least 14,000 had recent diabetes diagnoses.

New Onset Diabetes Cohort Sought to Unravel Complexities of Pancreatic Cancer Development was originally published by the National Cancer Institute.

TMIST Ramps Up to Illuminate Breast Cancer Screening

TMIST (Tomosynthesis Mammographic Imaging Screening Trial), the large NCI screening study to learn about the best ways to find breast cancer in women who have no symptoms, is ramping up with 16,505 participants enrolled to date at 84 certified mammography clinics in the United States, Canada and Argentina.

Photo of Etta Pisano

Etta Pisano, MD, chief research officer at the American College of Radiology, and the principal investigator of TMIST

The number of women and sites participating is likely to increase rapidly in the months ahead. Etta Pisano, MD, chief research officer at the American College of Radiology, and the principal investigator of TMIST, heads the efforts to get clinics involved.  “We have 15 approved clinics working on the logistics to begin enrollment, and another 34 have committed to joining. We are pleased that there has been a great deal of interest from international sites and expect to bring on additional sites in Europe and Asia in the next 6 months,” Dr. Pisano said.

TMIST is a randomized phase 3 trial comparing standard digital mammography (2-D) with the newer tomosynthesis mammography (3-D). The goal is to follow all participants to see if they are diagnosed with breast cancer or a precancerous condition, and to record their treatment and outcomes from the time of randomization until the end of the study.

TMIST was designed to provide evidence about the role of mammography screening in reducing the incidence of life threatening, advanced breast cancers. This is a stand-in for breast cancer mortality, the usual endpoint for screening trials, because a trial using that endpoint would take many more years to complete.

All told, 164,946 healthy women ages 45 to 74 who are already planning to get routine mammograms will be enrolled. Women will be randomized to either 3-D or 2-D screening mammograms for 5 years. Each woman is assigned to a screening frequency of every 1 or every 2 years, based on her individual risks for developing breast cancer.

While Medicare and many private insurance programs provide full cost coverage for screening mammograms, with no co-pay, copays are still allowed for some mammograms in some states.  Based on requests from women taking part in TMIST, some states are now funding co-payments or completely covering the participants’ cost for mammograms, according to the American College of Radiology (ACR).  The study also has some funding for uninsured patients subject to the charity care policies of the participating institutions.

States with Laws that Mandate
NO Co-pay for Screening Mammograms
States with Laws that Allow
Co-pays for Screening Mammograms
Arizona, Colorado, Connecticut, Illinois, Kansas, New Hampshire, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Vermont, Washington Kentucky, Louisiana, Maryland, Montana

TMIST is supported by the NCI Community Oncology Research Program (NCORP) and co-led by the ECOG-ACRIN Cancer Research Group. “About 50 million screening mammograms occur every year in the U.S. and it’s important to note that despite the technology disbursement, there is a research study going on to inform the science and the clinical practice,” said NCORP Director Worta McCaskill-Stevens, MD, MS.

Toward Personalized Screening Recommendations

TMIST researchers also are collecting evidence of significant secondary endpoints including false positives, recall rates, biopsy rates, and overdiagnosis. Data is collected on the results of every mammogram, whether the imaging shows no signs of cancer, findings suspicious of cancer, or a breast cancer. Medical follow-ups, such as more imaging or biopsies, also are reported.

Portrait of Worta McCaskill-Stevens

NCORP Director Worta McCaskill-Stevens, MD, MS

“Any increase in sensitivity with a new technology could be of benefit, harm, or a mixture, but only a randomized trial can sort it out,” Dr. McCaskill-Stevens added. “The average-risk woman will need personalized guidance about screening tests to make informed decisions around potential risks and benefits in the future.”

A key component of the trial is a biorepository with detailed clinical annotations. The subsequent molecular characterization of specimens and accompanying demographic information could help advance a personalized approach to screening recommendations that determines mammography use and intervals for each person based on their genetics and individual risk factors for developing breast cancer.

“The molecular evidence is the first step to personalizing breast cancer screening recommendations,” Dr. McCaskill-Stevens said. “The resulting dataset of clinical images and biospecimens will help us tailor future screening to each woman’s individual risk.”

More information and a list of participating sites is available from NCI and ECOG-ACRIN. For a discussion about the science involved in the study, see the article “Why I choose to play a dual role in TMIST” by Dr. McCaskill-Stevens in The Cancer Letter. “TMIST Trial Aims to Provide Clarity on Breast Cancer Screening Approaches” in the NCI Cancer Currents Blog offers more background on 2-D vs 3-D technology.

For more information about cancer clinical trials near you, click here.

 TMIST Ramps Up to Illuminate Breast Cancer Screening was originally published by the National Cancer Institute.

Clinical Trials at Southeastern Medical Oncology Center

SCOR member site Southeastern Medical Oncology Center (SMOC) uses the same guidelines, methods and protocols used by major cancer centers that patients can access close to home. Plus, we have a highly capable, informed and experienced team of cancer specialists, oncology nurses and support staff who combine exceptional training, knowledge and skill to give you every chance in the fight against cancer.  Since 1984, SMOC has been dedicated to providing the people of North Carolina the most advanced, effective and appropriate cancer care and hematology care available today. With genuine compassion and a deep commitment to your health, quality of life and best interests, we strive to offer not just the highest standard of care but also heartfelt understanding, comprehensive support and — ultimately — hope in the fight against cancer.

Expanding your treatment options and chances for cure.

types1At SMOC, we are committed to finding cures for cancer, and our doctors are nationally recognized for their contributions to this effort. One key way we are helping advance the fight against cancer is by getting involved in the investigation of new treatment options via clinical trials.

By participating in more than 100 different clinical trials (investigations of new potential treatments), we’re able to offer alternative options — and new hope — for people who don’t respond well to standard-of-care treatments.

What is a “clinical trial”?

clinical-trialsA clinical trial is a research study designed to test new medical techniques (medications, devices, etc.) and their effectiveness in the prevention, detection, diagnosis and cure of diseases. Clinical trials are investigations that let doctors determine if new approaches are safe, and identify the benefits and risks associated with them.

Clinical trials are, in fact, the method by which all medical therapies, devices and techniques are evaluated. Therefore, all treatments used today were first investigated through clinical trials. Likewise, tomorrow’s standard-of-care treatments will first go through clinical trials, and they may be getting investigated today. Without clinical trials, new drugs and treatments for cancer would not be investigated, get approved or come into use to benefit patients.

SMOC: Broad access to leading clinical trials.

At Southeastern Medical Oncology Center, we actively participate in several nationally and internationally recognized cancer investigational consortiums funded by the National Cancer Institute, including:

  • National Surgical Adjuvant Breast and Bowel Project
  • Southwest Oncology Group
  • Radiation Therapy Oncology Group
  • Cancer and Leukemia Group B
  • University of Rochester Cancer Center

In fact, SMOC is involved in the same clinical studies as major cancer centers, such as UNC, Duke and Sloan Kettering. Southeastern Medical Oncology Center is also active in pharmaceutical company trials for the development of emerging cancer therapies. This enables us to offer you or your loved one the “beyond-state-of-the-art” care people assume is only available at these major institutions.

Should you participate in a clinical trial?

shutterstock_191168837The decision to participate in a cancer clinical trial, or not, is an important decision that only you can make… and which should be considered carefully. Your views on scientific evidence, your feelings about your disease and your personal attitudes about health are all vital to consider.

Researching clinical trials is likely the best way to start figuring out if they may be right for you. Discussing the issue with your oncology specialist and your family is also vitally important. Clinical trials are not for everyone. So it’s important to weigh all aspects of the studies in your decision, including these considerations:


  • Care from cancer specialists on the leading edge of their field
  •  Access to new drugs that may not be otherwise available
  •  Information from your experience that can benefit other patients and possibly the future of cancer treatment
  •  Advancement of the scientific knowledge of cancer and cancer treatment


  • The risk of side effects
  • You may not be able to choose treatment in trials, such as in Phase III where treatments are randomly assigned
  • Your health insurance plan may not cover the study
  • Clinical trials may require more time than standard treatment

If you are considering participating in a clinical study, be sure to consult with your SMOC oncologist. He or she can recommend trials that may be most appropriate for you and answer any additional questions you may have about side effects, benefits, costs and quality-of-life.

To see which clinical trials SMOC is currently participating in, click here  to link to Southeast Clinical Oncology Research Consortium. To schedule an appointment, call 919-580-0000. You can also schedule an appointment using our easy online form.