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:
- 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.
- Commit to enrolling 500 subjects per year.
- 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.
- Register with the I-ELCAP Center each successive instance of baseline screening, and be committed to full documentation of this and repeat screenings.
- Identify and document each instance of interim diagnosis of lung cancer including symptoms and signs.
- Document the reason(s) for discontinuation of screening.
- Document the timing and nature of the intervention(s), if any, in each instance of diagnosed lung cancer, including interim-diagnosed cases.
- 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.
- Conform to all other I-ELCAP policies, most notably those concerned with quality assurance. (See page 11 of the I-ELCAP protocol.)
- 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.
- 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”.
- Send at least one Coordinator and Radiologist to the I-ELCAP Center for training prior to initiation of the study at the site.
- Purchase the appropriate relay computer to be installed at their institution so all study CT images can be sent to the I-ELCAP Center.
- 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.