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Research and Clinical Trials

Helping Survivors Thrive: Research at Johns Hopkins

Research is a critical component of The Michael J. Garil Leukemia Survivors Program. As survivorship increases dramatically among patients of childhood leukemia, we recognize that it's not enough to treat the disease itself. We also need to dedicate research efforts so that we can better understand post-survivorship health issues and minimize long-term complications—or late effects—that leukemia survivors may experience, such as cardiac toxicities, hyperthyroidism, secondary cancers, infertility, and developmental and cognitive delays.

The role of genetics in late effects

Genetics is an area of early but extremely promising research that we believe can reveal a great deal about childhood leukemia. Already, we know that children with inherited bone marrow failure syndrome are genetically predisposed to developing leukemia as well as solid tumors. Now, we are focusing on identifying the causative gene in one of these bone marrow syndromes, which will give us a better understanding of the mechanisms not only of bone marrow failure, but of cancer predisposition as well.

Another area of study is the predisposition that some women with breast cancer have to developing leukemia. We have identified a distinct group of women who only had surgery for their breast cancer, but then went onto developing leukemia. This strongly suggests an underlying genetic predisposition for developing both breast cancer and leukemia.  We are now working on identifying what genes could be contributing to this predisposition.

Genetic research also may be helpful in understanding whether gene mutations are responsible for predisposing childhood leukemia survivors to developing secondary cancers and other late effects such as cardiac, hearing, and pulmonary problems.

The next step in this area of research will be to take our understanding of the impact of survivors' genetic predispositions on late effects, and to monitor childhood leukemia survivors based on their genetic makeup.

Bone Marrow Transplantation and Bone Density

In a recent study, Hopkins researchers studied the effects of bone marrow transplantation (BMT) on childhood cancer survivors. We learned that patients who had undergone BMT are at increased risk for diminished bone mineral density (BMD), primarily osteopenia—a condition that may predict future osteoporosis and bone fractures. Survivors who were female, received CNS irradiation, and were older at the time of testing appeared to be at increased risk for BMT.

Also in this study, Hopkins researchers noted an association between a higher fat mass index (FMI) and increased BMD among obese children and adolescents who had undergone BMT. Based on this connection, we suggest that exercise interventions designed to increase BMD in childhood BMT survivors should consider the relationship between bone, muscle, and fat, and should introduce interventions that have a positive impact on survivors' overall health.

Get Involved

There are some specific ways that you can get involved to learn more late effects after childhood cancer as well helping our scientists better understand these issues.

  • Share information regarding your medical history with the Life Clinic, so we can add it to a database developed by the Children's Oncology Group, the largest global consortium of researchers dedicated to studying and eradicating childhood cancers.
  • Regularly review our list of clinical trials for which we're recruiting patients, and consider enrolling in those for which you may be eligible. Below, you’ll find a list of Johns Hopkins clinical trials of special interest to leukemia survivors for which we're currently recruiting patients.

Clinical Trials Now Open at Johns Hopkins – Spring 2012

Endothelial Function, Arterial Stiffness and Components of Metabolic Syndrome in Acute Lymphoblastic Leukemia Survivors
Principal Investigator:
Kathy Ruble, RN, CPNP, PHD Johns Hopkins SKCCC
Office Phone: 410-614-5062
Email: rubleka@jhmi.edu
Co-Investigator:
Hae Ra Han, RN, PhD Associate Professor,Johns Hopkins University, SON
Office Phone: 410-614-2669
Email: hhan@son.jhmi.edu

The primary objective of this study is to compare endothelial function, as measured by the reactive hyperemia index (RHI) with the peripheral artery tonometry (PAT) device, of childhood ALL survivors to healthy sibling controls.
Eligibility Survivor:
Inclusion
1. Ages 8-28 (8 is chosen as lower age limit because developmental understanding will allow survivor to follow instructions for procedures, 28 is chosen as upper limit to include age ranges seen for treatment in the pediatric program)
2. Off therapy for at least 6 months and not more than 10 years (6 months will allow adequate time for recovery from acute toxicity
Exclusion
1. Uncontrolled medical conditions that could interfere with participation or interpretation of results
2. History of relapsed ALL or history of bone marrow transplantation
Sibling:
Inclusion
1. Biological sibling
2. Ages 8-28 (when more than one sibling is available the one closest in age will be chosen.)
Exclusion
1. Uncontrolled medic al conditions that could interfere with participation or interpretation of results.

Sleep Disturbances Among Child and Adolescent Cancer Survivors
Principal Investigator: 
Kathy Ruble, RN, CPNP, PHD Sidney Kimmel Cancer Center
Office Phone: 410-614-5062
Email:  rubleka@jhmi.edu
Co-Investigator:  
Anna George, Psy.D Postdoctoral Fellow, Pediatric Psychology Consultation Program, Kennedy Krieger Institute
Office Phone: 443-923-2931
Email:  georgea@kennedykrieger.org
The primary objective of this study is to evaluate the association of waist circumference and sleep disordered breathing (SDB) in child and adolescent cancer survivors enrolling in the survivorship program at Hopkins.  We hypothesize cancer survivors with waist circumference greater than the 85th percentile according to NHANES data will have higher scores on the breathing subscale of the Pediatric Sleep Questionnaire (PSQ)  than those with waist circumference less than the 85th percentile25. 

Eligibility Inclusion:
1. Prior treatment with surgery, radiation or chemotherapy for a childhood cancer or non-malignant disease requiring this therapy (example aplastic anemia)
2. Currently off therapy and in remission
3. Currently aged 6-18
4. Able to read/understand English or have interpreter available

For more information on all clinical trials at Johns Hopkins, including your rights, protections and eligibility, visit our Clinical Trials page.

To search for clinical trials throughout the United States, visit Clinical Trials.gov, a free service of the National Institutes of Health.

Who Pays For Clinical Trial Medical Costs?

Even if you have health insurance, your coverage may not include some or all of the costs associated with a clinical trial. This is because some health plans define clinical trials as “experimental” or “investigational” procedures. However, they may be willing to pay if the trial treatment is similar to a standard treatment. Because lack of coverage for these costs can keep people from enrolling in trials, the Johns Hopkins is working with major health plans and managed care groups to find solutions.

 

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