{
"info": {
"nct_id": "NCT00250848",
"official_title": "Lung Cancer Case Registry and Tissue Resource",
"inclusion_criteria": "* Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or evaluated for possible treatment of lung cancer at the CRTC and NMVHCS. Recruiting will primarily be performed through the Multidisciplinary Chest Clinics held weekly at each hospital. These clinics are staffed by the Principal Investigator (PI) and Reza Mehran, MD, a thoracic surgeon at both hospitals and a co-investigator on this submission. Approximately 90% of all lung cancer cases diagnosed at the NMVHCS, and a somewhat smaller proportion of cases treated in the Cancer Center, are seen in these clinics. Additional cases will be identified through review of new patient visits to each hospital with a diagnosis of lung cancer; Drs. Crowell and Mehran also maintain weekly contact with pathology and oncology services at both facilities, which will facilitate case identification at NMVHCS and University Hospital. Finally, patient contact records will be correlated with tumor registry records at both hospitals, which will identify any cases not captured through the above mechanisms. Although these cases may be identified several weeks after initial diagnosis, all attempts will still be made to contact the patient and family for enrollment into the registry. Most Spanish-speaking patients served by the CRTC and the NMVHCS are bilingual, and a language barrier has not been a problem in other similar studies conducted by the PI. However, Spanish-speaking personnel are available to obtain consent and answer any questions if necessary.\nHealthy volunteers allowed",
"exclusion_criteria": "* Patients will be excluded if they cannot provide written informed consent.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Potential participants in the Lung Cancer Case Registry will be all patients diagnosed or evaluated for possible treatment of lung cancer at the CRTC and NMVHCS. Recruiting will primarily be performed through the Multidisciplinary Chest Clinics held weekly at each hospital. These clinics are staffed by the Principal Investigator (PI) and Reza Mehran, MD, a thoracic surgeon at both hospitals and a co-investigator on this submission. Approximately 90% of all lung cancer cases diagnosed at the NMVHCS, and a somewhat smaller proportion of cases treated in the Cancer Center, are seen in these clinics. Additional cases will be identified through review of new patient visits to each hospital with a diagnosis of lung cancer; Drs. Crowell and Mehran also maintain weekly contact with pathology and oncology services at both facilities, which will facilitate case identification at NMVHCS and University Hospital. Finally, patient contact records will be correlated with tumor registry records at both hospitals, which will identify any cases not captured through the above mechanisms. Although these cases may be identified several weeks after initial diagnosis, all attempts will still be made to contact the patient and family for enrollment into the registry. Most Spanish-speaking patients served by the CRTC and the NMVHCS are bilingual, and a language barrier has not been a problem in other similar studies conducted by the PI. However, Spanish-speaking personnel are available to obtain consent and answer any questions if necessary.",
"criterions": [
{
"exact_snippets": "patients diagnosed or evaluated for possible treatment of lung cancer",
"criterion": "lung cancer diagnosis or evaluation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at the CRTC and NMVHCS",
"criterion": "location of diagnosis or evaluation",
"requirement": {
"requirement_type": "location",
"expected_value": [
"CRTC",
"NMVHCS"
]
}
},
{
"exact_snippets": "Spanish-speaking patients served by the CRTC and the NMVHCS are bilingual",
"criterion": "language proficiency",
"requirement": {
"requirement_type": "bilingual",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "patients diagnosed or evaluated for possible treatment of lung cancer",
"criterion": "lung cancer diagnosis or evaluation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at the CRTC and NMVHCS",
"criterion": "location of diagnosis or evaluation",
"requirement": {
"requirement_type": "location",
"expected_value": [
"CRTC",
"NMVHCS"
]
}
}
]
},
{
"exact_snippets": "Spanish-speaking patients served by the CRTC and the NMVHCS are bilingual",
"criterion": "language proficiency",
"requirement": {
"requirement_type": "bilingual",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients will be excluded if they cannot provide written informed consent.",
"criterions": [
{
"exact_snippets": "cannot provide written informed consent",
"criterion": "written informed consent",
"requirement": {
"requirement_type": "ability to provide",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "cannot provide written informed consent",
"criterion": "written informed consent",
"requirement": {
"requirement_type": "ability to provide",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}