Archive for December, 2014

Cancer Registry Studies: At Least One for Everyone

clipboard2When thinking about breast cancer research, clinical trials investigating new drug treatments are often the first thing that comes to mind. But there is another type of research study that tends to get much less attention: breast cancer registry studies.

Most people are familiar with the concept of a registry, either having created one for a wedding or new baby or selected a gift from one for a bride or groom. These types of registries are well-organized lists of the gifts a person is hoping to receive. A registry study is similar: It is a well-organized set of questions. But instead of giving a gift, you give answers to the researchers’ questions. In some cases, you also provide a blood or tumor sample that researchers can use in the future. This can help them identify biological markers that might, for example, provide information about a tumor’s aggressiveness or the types of treatments it will respond to. The blood sample might also be used to identify new genetic mutations that increase or decrease breast cancer risk.

A registry study may require you to complete one questionnaire and give one blood sample. Or it may involve completing a series of questionnaires over time. Registry studies that follow people over time allow researchers to identify possible correlations between an action (like exercise) and an outcome (like breast cancer recurrence). Some registry studies are conducted solely online; others require enrollment at a research site. Some registries are established by university- or government-affiliated researchers, while others are organized by non-profits. All provide opportunities to participate in a research study that can advance our understanding of breast cancer.

The Cancer Experience Registry is an example of an online registry study conducted by a nonprofit—in this case the Cancer Support Community. This registry is open to anyone who has had a cancer diagnosis, whether they were diagnosed a week ago, are currently undergoing treatment, or are a long-term survivor. Researchers intend to use the information collected through the Cancer Experience Registry to develop programs that address the emotional and social needs of cancer patients and survivors. Individuals who enroll in the registry are asked questions about their diagnoses, overall health, and the impact cancer and its treatments have had on them physically, financially, socially, and emotionally. By conducting the registry trial completely online, the Cancer Support Community is hoping to reach and glean information from a broad a range of cancer survivors.

The SystHERs Registry (Systematic Therapies for HER2+ Metastatic Breast Cancer Study) is an example of a registry that is enrolling patients at a research site—in this case, 100 research sites nationwide. A group of academic researchers started this registry in order to learn about how doctors in the “real world”—outside of clinical trials—are using the new HER2-targeted treatments in women with HER2+ metastatic breast cancer. The researchers are also asking questions about the side effects patients are developing and collecting information on how the tumor is responding to the treatment.

All of the registry trials listed on BCT can be found here.

December 9, 2014 at 4:53 am Leave a comment

Q&A With Dr. Stanley Rockson, Founder of the National Breast Cancer Lymphedema Registry


Dr. Stanley Rockson

Lymphedema —a specific form of swelling of the arm or hand that is often painful—is a common long-term side effect of breast cancer treatments. Stanley G. Rockson, MD, the Director of the Center for Lymphatic and Venous Disorders at Stanford University Medical Center in California, established the National Breast Cancer Lymphedema Registry to learn more about why some women develop lymphedema and others do not. BCT spoke with Dr. Rockson about what the registry can teach researchers and how it can help breast cancer patients.

Q: Why did you decide to develop this registry?
A: Breast cancer survivorship is so phenomenally good, and there are many women who can hope to live out their natural lifespan. If you’ve beaten a life threatening disease and then develop lymphedema, which affects your appearance and sense of wellbeing, it affects your quality of life.  So it’s important to figure out the best way to minimize the problem and optimize detection and treatment. That was our motivation for starting this registry and we hope that it will allow us to make an impact on this common problem.

If we can determine that certain strategies reduce the intensity of lymphedema or the amount of care that is required, that would be an impetus for doctors to adopt those strategies. Also, by asking questions about the treatments received, we hope to be able to tease out the impact of breast cancer from the impact of lymphedema. Currently, all of this is very poorly understood.

Q: What is the advantage of collecting this information in a registry?
A: A registry is not as statistically rigorous as a prospective trial, but because ours is web-based it does allow us to escape the limitations of geographic locale—we have registrants from every state and every region in the U.S. This is useful because there are big geographic differences in the availability of resources for the treatment of lymphedema. The registry allows us to capture data from the broadest possible perspectives and touch the largest number of lives.

Q: Is there just one survey?
A: No, it is a longitudinal study. We check in on women quarterly for the first year after surgery, because that’s when they are at the highest risk for developing lymphedema—and we continue to follow them after that.

Q: How many women have signed up?
A: We started about three years ago and now have between 400 and 500 participants. We’d like to have at least 1,000 women enrolled. I know that there are a lot of survivors who like to think about how to help themselves and help others and this is a wonderful cost-free and risk-free way to participate in clinical research.

Q: Do you need to be newly diagnosed?
A: No. We are not limiting anyone from being part of the registry. We have some women who already have lymphedema, and their being part of the study will help shed light on how lymphedema is currently managed. We value all the data we can collect from anyone who has had breast cancer.

December 9, 2014 at 4:44 am Leave a comment

Terry Arnold: Why I Joined a Registry Study

terry.arnoldTerry Arnold is participating in the Inflammatory Breast Cancer Registry at the M. D. Anderson Cancer Center, in Houston. This registry is collecting blood and tissue samples and treatment information from patients with inflammatory breast cancer (IBC). The samples are banked at the
M. D. Anderson Cancer Center for use in future research studies. BCT spoke with Arnold about her experience.

Q: When were you diagnosed with IBC?
A: I was diagnosed in the summer of 2007, at age 49. My breast became red and swollen and puffed up. My doctor thought I had an infection and put me on antibiotics. I was misdiagnosed five times over a period of four months. I live in Houston and ultimately I ended up at M. D. Anderson, where I was diagnosed with triple negative IBC in that breast and a triple negative tumor in the other breast.

Q: How did you learn about the IBC registry?
A: The researchers told me about the registry and I enrolled because I wanted to do anything I could to help researchers learn more about IBC. I had no history of breast cancer in my family, I had breastfed five children and I was not overweight. That was something I had hoped would reduce my risk of breast cancer. I was careful about my weight because we have a history of diabetes in my family. I didn’t think breast cancer was in my future and I wanted my doctors to figure out why this had happened to me so it would not happen to anyone else.

Q: What was involved?
A: The registry requires a blood sample, so they did double withdrawals of blood. It was no big deal. Then I completed a lot of surveys that asked about alcohol, food, where I lived, my lifestyle—all kinds of questions. There was never any pressure. They were almost apologetic about how many questions there were.

Q: Have you encouraged other women to get involved in clinical trials?
A:  All the time. Women often put their families first and worry about extra time or travel required for a trial, but they need to put themselves at the head of the line. Some of us are standing on the shoulders of giants, of others who took part in trials that helped us, and taking part is a way we can pay it forward.

December 9, 2014 at 4:41 am 5 comments

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