Approved Ancillary Studies

POGO: Pediatric Cancer Outcomes Initiative (PCOI)

Effective estimation of second cancer risks and resultant possible improvements in treatment protocols

Siv Sivaloganathan (University of Waterloo)

Canadian Institutes of Health Research – NSERC CHRP

Active

To develop predictive models of second cancer risk among adolescent Hodgkin lymphoma patients based on 3-dimensional normal tissue radiation dosimetry.

Neurofibromin and response to genotoxins

Jean Nakamura (University of California, San Francisco)

St. Baldrick’s Foundation

Active

(1) Determine whether loss of heterozygosity in tumor suppressor genes identified in the Nf1 mutant mouse model occurs in second malignant neoplasms of childhood cancer survivors, and (2) determine whether transcript levels of candidate tumor suppressor genes are reduced in second malignant neoplasms.

Diet and insulin resistance in survivors of childhood leukemia

Emily Tonorezos (Memorial Sloan Kettering Cancer Center)

American Cancer Society (Career Development Award)

Active

1) Determine the effectiveness of a remotely delivered diet and physical activity intervention among obese ALL survivors, 2) Calculate the effect of the diet and physical activity intervention on insulin, leptin/adiponectin, and lipids.

Diet and insulin resistance in survivors of childhood leukemia

Emily Tonorezos (Memorial Sloan Kettering Cancer Center)

American Institute for Cancer Research

Active

1) Determine the effectiveness of a remotely delivered diet and physical activity intervention among obese ALL survivors, 2) Calculate the effect of the diet and physical activity intervention on insulin, leptin/adiponectin, and lipids.

Bone Deficits and Excess Adiposity after Pediatric Bone Marrow Transplantation

Sogol Mostoufi-Moab (University of Pennsylvania)

National Institutes of Health (K07 CA166177)

Active

Among survivors of HSCT to characterize changes in bone density and structure, body composition and fat distribution, and associated risk factors and outcomes.

Risk Reduction and Early Detection Strategies for Skin Cancer Control among Childhood Cancer Survivors

Alan Geller (Harvard School of Public Health

National Institutes of Health (R01 CA175231)

Active

(1) Determine the impact of a patient activation and education intervention with and without physician education and teledermatology on skin cancer early detection practices and (2) Determine the impact of patient activation and education on utilization.

Longitudinal Evaluation of Health Status in Survivors of Pediatric Astrocytoma

Karen Effinger (Stanford University)

ASCO Conquer Cancer Foundation Young Investigator Award (YIA)

Active

To evaluate 1) Health status, 2) Chronic Health Conditions and  3) Treatment-related risk factors among survivors of astrocytoma.

Diet and insulin resistance in survivors of childhood leukemia

Emily Tonorezos (Memorial Sloan Kettering Cancer Center)

National Institutes of Health (R01)

Active

1) Determine the effectiveness of a remotely delivered diet and physical activity intervention among obese ALL survivors, 2) Calculate the effect of the diet and physical activity intervention on insulin, leptin/adiponectin, and lipids.

Maria Gramatges (Baylor College of Medicine)

National Institutes of Health (R01)

Active

1) Determine whether SNPs associated with telomere maintenance are enriched in survivors with thyroid SMN (GWAS), 2) To look at impact of defects in telomere maintenance genes upon telomerase function

Developmental HyperActive Ras Tumor SPORE, (Subsequent Malignant Neoplasms among individuals with NF1)

Smita Bhatia (City of Hope)

National Institutes of Health (SPORE)

Active

1) to implement effective targeted molecular therapies for neoplasms and cancers characterized by NF1 mutations by conducting integrated, mechanistically based translational research. 2) to describe risk of SMNs and demographic/therapeutic factors associated with SMNs in individuals with NF1 and primary cancer

Symptom Progress and Adverse Health Outcomes in Adult Survivors of Childhood Cancer

I-Chan Huang (St. Jude Children’s Research Hospital)

National Institutes of Health (R21)

Active

(1)  To investigate individual symptom  categories and clusters across multiple time points

(2)  To investigate the prognostic value of symptoms for developing chronic conditions

New Methods to Address Dilemmas in Mixed Recurrent-event and Panel-count data

Liang Zhu  (St. Jude Children’s Research Hospital)

National Institutes of Health (R21)

Active

Develop Semi-parametric methods for regression analysis of mixed recurrent event data with terminal events

Cost effectiveness of breast cancer screening guidelines for female survivors of pediatric cancers

Lennie Wong (City of Hope)

American Cancer Society

Active

Advancing Survivors Knowledge About Skin Cancer (ASK)

Alan Geller (Harvard School of Public Health)

National Institutes of Health (R01 CA175231)

Active

(1) Determine the impact of a patient activation and education intervention with and without physician education and teledermatology on skin cancer early detection practices and (2) Determine the impact of patient activation and education on utilization.

Improving Cancer Screening Guidelines for Survivors of Childhood Cancer

Jennifer Yeh (Harvard School of Medicine)

American Cancer Society

Active

1) Develop a microsimulation model of the natural history of late-effects among childhood cancer survivors; 2) Use the model to project the disease burden, in terms of morbidity and mortality, associated with late-effects among treatment-exposure subgroups; and 3) Assess the comparative effectiveness (and cost-effectiveness) of recommended screening strategies for secondary breast and colorectal cancers to improve long-term outcomes among at-risk survivors.

Risk Prediction Model of Premature Menopause in Childhood Cancer Survivors

Yan Yuan (University of Alberta)

Canadian Institutes of Health Research

Active

To develop a prediction model for early menopause.

Communicating Health Issues and Improving Coordination with Primary Care (CHIIP)

Eric Chow (University of Washington)

National Institutes of Health (R01)

Active

1) Determine prevalence of under diagnoses and under treatment of traditional cardiovascular risk factors, 2) Randomized controlled intervention to improve risk factors, 3) Determine barriers that lead to under diagnosis and under treatment.

Late Effects Prediction using Clinical Phenotypes and Whole Genome Sequencing

Yutaka Yasui, Jinghui Zhang (St. Jude Children’s Research Hospital)

National Institutes of Health (RO1)

Active

1) Build individual risk prediction models with the SJLIFE cohort for 11 outcomes including meningioma, basal cell carcinoma, and multiple subsequent neoplasms, 2) Validate the risk prediction models a larger cohort study with higher SN counts (CCSS).

Statistical Analysis for Mixed Outcome Measures in Recurrent Event Studies

Liang Zhu (University of Texas MD Anderson)

National Cancer Institute (R03)

Active

Develop a likelihood-based semiparametric estimation method for regression analysis of mixed panel-binary and panel-count data.

EMPOWER II: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Kevin Oeffinger (Duke University)

National Institutes of Health (R01)

Active

To determine the efficacy of smart phone, text-based patient and physician activation to improve breast MRI and mammography screening rates.

Risk Factors for Female Breast Cancer After Treatment for Childhood and Adolescent Cancer: An Individual Patient Data Analysis

Cecile Ronckers (Princess Maxima Center for Pediatric Oncology, Utrecht)

Kika Foundation

Active

1) Establish an internationally pooled and harmonized database for breast cancer outcomes, 2) Answer three questions identified by the International Harmonization Guidelines for risk for subsequent breast cancer including risk <20Gy, associated with anthracycline exposure and attained age >50 years.

Breast Cancer after Treatment for Childhood Cancer

Lucie Turcotte, University of Minnesota

National Institutes of Health (K08)

Active

1) Quantify OS and EFS among CCSS participants with breast cancer and compare with SEER cohort of women with primary breast cancer, 2) Compare prescribed treatment and breast cancer treatment-related toxicity between CCSS participants with breast cancer and a comparison cohort of women with primary breast cancer, 3) Perform semi-structured interviews with medical and radiation oncologists to understand drivers of treatment decision-making, and use responses to create a survey for distribution to medical and radiation oncologists.

Genetic Testing to Guide Pediatric Cancer Care and Follow-up: Using Anthracycline-Associated Cardiomyopathy as a Model for the Future

Jennifer Yeh (Harvard School of Medicine)

National Institutes of Health (Provocative Questions R01)

Active

1) Determine the clinical utility of ca simulation model of cardiotoxicity genetic risk factors in guiding cancer care, 2) Assess how consideration of genetic markers can improve follow-up cardiomyopathy screening recommendations for at-risk survivors.

Developing a Health Insurance Navigation Program for Childhood Cancer Survivors

Elyse Park (Harvard School of Medicine)

American Cancer Society

Active

1) To develop a psychoeducational health insurance navigation program (HINP), 2) To conduct a pilot randomized trial of the HINP, 3) To refine the HINP program for future use.

Developing a Patient Reported Outcomes Version of the CTCAE for Survivors of Childhood Cancer (PRO-CTCAE-SCC)

I-Chan Huang, Justin Baker (St. Jude Children’s Research Hospital)

National Institutes of Health (R01)

Proposed

To conduct item creation, selection and validation of a PRO-CTCAE-SCC based on the current patient-reported outcomes version of the Common Terminology Criteria for Adverse Events.

Impact of eHealth intervention for insomnia on late effects of childhood cancer

Tara Brinkman(St. Jude Children’s Research Hospital)/Kevin Krull (St. Jude Children’s Research Hospital)

National Institutes of Health (R01)

Proposed

To assess the impact of insomnia treatment on neurocognitive impairment, symptoms of emotional distress, and indices of cardiovascular health in survivors of childhood cancer.

Biological Mechanisms of Accelerated Aging Evidenced as Frailty in Survivors of Childhood Leukemia

Monica Gramatges, Philip Lupo, Kiri Ness (Baylor College of Medicine and St. Jude Children’s Research Hospital)

National Institutes of Health (Provocative Questions R01)

Proposed

To assess the associations between physiologic frailty and telomere length (Aim 1), systemic inflammation (Aim 2), DNA methylation (Aim 3).

Improving Delivery of Genetic Services to High Risk Childhood Cancer Survivors: A Randomized Study of Remote Genetic Services Versus Usual Care

Tara Henderson (Univ. of Chicago)/Angela Bradbury(Univ. of Pennsylvania)

National Institutes of Health (R01)

Proposed

1) To Evaluate the efficacy of remote telegenetic services (telephone or videoconferencing) compared to usual care to increased uptake of genetic counseling, genetic testing and identification of germline genetic mutation carriers, 2) To evaluate the efficacy of real time video conferencing to provide greater knowledge and recall of results, decrease distress and improved satisfaction with genetic services compared to telephone delivery.

The Immunobiology of Long-Term Survival in Twins Discordant for Childhood Cancer

Wendy Cozen (University of Southern California)

:  National Institutes of Health (R01)

Proposed

1) Define immunologic alterations associated with pediatric leukemia / lymphoma survivorship (encompassing the cancer and its treatment by quantifying 16 systemic biomarkers of immune activation and inflammation in pediatric cancer survivors and their unaffected identical co-twins as controls. 2) Determine whether pediatric survivors have accelerated epigenetic aging compared to their unaffected twins, 3) Determine whether the gut microbiome is adversely altered in survivors.

Prevalence and Risk of Frailty in Survivors of Childhood Cancer

Todd Gibson/Kiri Ness (St. Jude Children’s Research Hospital)

National Institutes of Health (R01)

Proposed

1) To determine the prevalence of frailty and pre-frailty, 2) To identify associations between treatment exposures and frailty, and 3) To evaluate associations with quality of life.

Developing a Clinical and Genetic Risk Prediction Model for Diabetes Mellitus among Survivors of Childhood Cancer

Philip Lupo (Baylor College of Medicine)

National Institutes of Health (R01)

Proposed

1) To determine the prevalence of frailty and pre-frailty, 2) To identify associations between treatment exposures and frailty, and 3) To evaluate associations with quality of life.