Amyotrophic Lateral Sclerosis (ALS- Cohort)

Amyotrophic Lateral Sclerosis (ALS) is a multisystem neurodegenerative condition with predominant motor system involvement. Its worldwide prevalence is 4.5 per 100,000 people, and its incidence is 0.78 per 100,000 person-years. The disease burden is high, with over 330,000 individuals affected globally causing nearly 1 million disability-adjusted life-years and 34,325 deaths annually. The incidence of ALS is projected to rise by 69% in the next few decades.

The progression of ALS is typically rapid, with patients experiencing a gradual loss of muscle control and strength. As the disease progresses, individuals may have difficulty speaking, swallowing, and breathing, ultimately leading to respiratory failure. Although there is no cure for ALS, supportive care and therapies such as respiratory support, physical therapy, and speech therapy can help to manage symptoms and improve quality of life.

Breast Cancer Cohort

Breast cancer is a primarily female disease, with only 1% of cases occurring in men. It is estimated that 1 in 8 women born today will be diagnosed with breast cancer during their lifetime. In 2013, it was predicted that 232,340 women would be diagnosed with and 39,620 would die from breast cancer. Survival rates vary depending on the stage at diagnosis, with a high five-year relative survival rate (98.6%) for cancers that are confined to the primary site and a poor rate (24.3%) for metastatic disease. 

Breast cancer incidence has increased over time, attributed to changes in reproductive risk factors, mammography screening, obesity, and post-menopausal estrogen use. African American women have lower survival rates and are diagnosed with larger tumors more often than white women. Personalized therapy has been successful in treating specific molecular subtypes of breast cancer, but access to these therapies may vary based on socioeconomic factors. Patient-centered studies are needed to eliminate health disparities and answer questions that are not typically addressed in traditional clinical trials.

When mature, the PCORI national network should greatly enhance and complement existing cooperative group trial mechanisms—for example, to assist in efficient recruitment to reduce trial costs and ascertain sufficient cohort sizes. We believe the GPC and the national CDRN-PPRN network will provide the breakthrough needed to accelerate research progress by providing the infrastructure needed to access and work with patients in CER and other research on breast cancer and its treatment.


Weight Cohort

Obesity continues to receive considerable attention in both the scientific and lay literature due to the rapid rise in the prevalence of obesity over the past two decades. The general consensus is that a major cause of this is an environment that promotes caloric intake and discourages caloric expenditure. Most of the short- and long-term consequences of obesity for the individual are well-known and well-described, ranging from orthopedic disorders to diabetes and cardiovascular disease. The economic consequences of obesity-related illness are rapidly approaching $200 billion, representing about 25% of annual medical spending in the US.18 The indirect and mortality costs are 2-3 folds greater than the direct costs. Page 5 of 17 Revised: version 2, 2023

Childhood obesity, 19 in particular, has increased significantly in the past two decades. For example, in the early 1990s (1988-1994, NHANES III)) prevalence of obesity in adolescent boys (12-19 years) was 11.3%. By 2009-2010 this increased to 19.6%. An even more dramatic rise was seen among young boys (2-5 years), with prevalence rates more than doubling (6.2% to 14.4%). Childhood obesity appears to disproportionately affect certain racial and ethnic groups. For example, the prevalence of obesity among non-Hispanic black girls is 24.8% compared to 14.7% for non-Hispanic white girls. The resulting health and economic devastation over the next few decades is unimaginable, especially since many of the “long-term consequences of obesity” (e.g., type 2 diabetes and cardiovascular disease) are now being seen in adolescents.20 Even in the pediatric population, analyses suggest that both the number of hospitalizations and the costs of hospitalizations directly related to obesity are rising rapidly.