Background

Mount Sinai Health System’s I-ELCAP program is led by pioneers in the field of early lung cancer research, who have conducted extensive research in the field for over 20 years. In 1991, physicians from Cornell University Medical Center (now Weill Medical College of Cornell University), concerned with the lack of available tools to detect early stage lung cancer, worked with fellow specialists to develop a viable method using helical CT imaging. Thus in 1992, ELCAP (Early Lung Cancer Action Program) was born. Designed to determine the difference in proportion of early stage disease between two methods of early diagnosis, chest radiography and low-dose CT, this regimen of screening recommended and defined the further workup of findings on the CT scan before the subsequent round of screening. The routine is critical as it embodies the concept that screening is a clinical diagnostic process, not simply a standalone test. The ELCAP methodology can provide relevant diagnostic information with any precision desired from even just two rounds of screening (a baseline round and one single repeat annual round). By enrolling a sufficient number of individuals in the required 2 years of screening, the design provided a new determination of the cure rate of lung cancer which could be achieved under screening (as compared to that under usual care). As such, “under screening” is a specific term which refers to the diagnoses of lung cancer made solely while participants are undergoing any given round of screening (both screen-diagnosed and interim-diagnosed cases).

To this end, ELCAP principle investigators at Weill Cornell Medical College invited the investigators at New York University Medical Center to participate in this study and together they screened 1,000 high-risk, asymptomatic participants. The results indicated that over 80% of the lung cancer diagnoses were of clinical Stage I. ELCAP’s findings were published in 1999 in the Lancet, which inspired further research efforts on CT screening for lung cancer throughout the world in the form of screening research studies at 12 institutions throughout New York State, called the NY-ELCAP, which replicated the same results. Simultaneously, in 1999, ELCAP started to host international conferences which led to the development of valuable protocols. This allowed for international collaboration and data pooling throughout the world.

Since then, in depth discussions of topical screening research questions have been held at the twice yearly International Conferences on Screening for Lung Cancer. By pooling data collected under this protocol from many national and international institutions, I-ELCAP was able to show, in several 2006 publications that 1) lung cancers diagnosed under screening were typically small, including small-cell carcinomas, and 2) the estimated cure rate of patients whose lung cancer was diagnosed under screening. After long-term follow-up of 31,456 asymptomatic participants, 484 of whom had lung cancer diagnosed under CT screening of which 414 (86%) had clinical Stage I disease, the estimated overall cure rate for the 484 patients diagnosed under CT screening was 80% (95% CI: 74% – 85%). With these and other publications, I-ELCAP has remained at the forefront of screening research and is often the first to call attention to important new topics. Such topics included, among many others, nodule growth rate assessment, identification of different types of nodules (solid, part-solid, and nonsolid), differing pathologic findings and survival rates, identification of emphysema, coronary artery calcifications, mediastinal masses, and the importance of including smoking cessation into the screening program.

In 2011, I-ELCAP was relocated to Mount Sinai Health System, and continues to operate here today. This transition provided I-ELCAP access to a larger research population and helps fuel the expansion throughout New York City, as well as internationally. **As they continued to detect and study early-stage lung cancers, the need for an analysis of long term, early stage treatment options became apparent. I-ELCART (Initiative for Early Lung Cancer Research on Treatment), is a research study, which has been tracking the long-term quality of life for various early-stage lung cancer treatments since March 2016.

Numerous publications document the findings of the I-ELCAP members’ work. Among these findings as already stated above:

• Curability of Stage I lung cancers is 80-90%
• Annual CT screening allows at least 80% of lung cancers to be diagnosed at clinical Stage I
• CT screening creates a counseling opportunity that results in greater smoking cessation
• CT screening also provides quantitative and prognostic information on emphysema and coronary artery calcifications
• Cost of CT screening for lung cancer compare favorably with breast, cervical, and colon cancer screenings

Research is ongoing, incorporating larger pools of patient data to reaffirm early findings and suggest new directions for future research and recommendations. Today’s full I-ELCAP member list can be viewed here.