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Joining I-ELCAP

Criteria for admission

The research group will consist of one, or more, board certified radiologist, pulmonologist, thoracic surgeon, pathologist and oncologist.

The research group and their institution will:

  1. Implement the screening regimen of early diagnosis specified in the I-ELCAP protocol. (Subject risk profiles and intervention policies may vary.) Commitment to a minimum of one repeat screening per subject is required.
  2. Commit to enrolling 500 subjects per year.
  3. Submit to the I-ELCAP Center documents approving the screening and participation in I-ELCAP, conform to the stated requirements, and agree to periodic I-ELCAP Center audits for adherence to requirements. 
  4. Register with the I-ELCAP Center each successive instance of baseline screening, and be committed to full documentation of this and repeat screenings. 
  5. Identify and document each instance of interim diagnosis of lung cancer including symptoms and signs. 
  6. Document the reason(s) for discontinuation of screening. 
  7. Document the timing and nature of the intervention(s), if any, in each instance of diagnosed lung cancer, including interim-diagnosed cases. 
  8. Follow each diagnosed case of lung cancer, interim-diagnosed cases included, until fatal outcome or, in the absence of evidence of spread, for up to 10 years; and document the follow-up. 
  9. Conform to all other I-ELCAP policies, most notably those concerned with quality assurance. (See page 11 of the I-ELCAP protocol.) 
  10. Utilize the web-based ELCAP management system for CT screening for lung cancer, and using this framework, submit research data including images to the I-ELCAP Center for review and storage. 
  11. Include in the patient consent form the following language: “For study purposes, all data from your exams are immediately entered into the web-based interactive system and automatically transmitted to the institution’s data repository at the I-ELCAP Center”. 
  12. Send at least one Coordinator and Radiologist to the I-ELCAP Center for training prior to initiation of the study at the site. 
  13. Purchase the appropriate relay computer to be installed at their institution so all study CT images can be sent to the I-ELCAP Center. 
  14. Require the Principal Investigator (PI) to attend I-ELCAP’s semi-annual conferences on Screening for Lung Cancer. If the PI is unable to attend, a radiologist from the site should attend in his or her place.

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