Cancer Diagnosis

The NLST confirmed diagnoses of lung cancer through medical record abstraction (MRA) of participants suspected by the trial to have lung cancer. MRA was triggered by:

• a self-report of lung cancer on a study update form (annual for LSS, semi-annual for ACRIN)
• positive CT or X-ray screening exam
• death certificate indicating lung cancer
• a relative informing screening center of participant's cancer (this was infrequent)
• suspicion of non-lung cancer that was determined (by MRA) to be lung cancer (e.g. metastasis to brain from a lung primary)

Note that if the MRA process did not find records indicating a lung cancer diagnosis, the lung cancer was not considered confirmed, even if a source such as a death certificate indicated lung cancer.

Data collection was pursued for all lung cancers diagnosed at any time during NLST. This included additional primary lung cancers diagnosed after the first, not just the first lung cancer per participant. The focus of data collection was on characteristics of the cancer at the time of diagnosis.

Cancer stage was originally classified according to the AJCC 6 manual, but AJCC 7 stage data are also available from a re-review of medical records after study closeout.

The Participant dataset contains sufficient information on lung cancer diagnosis to be useful for many purposes. Additional information is available in a separate Lung Cancer dataset, which contains one record per primary lung cancer.

Summary

• ~2050 participants were diagnosed with lung cancer during NLST
• Data are available for confirmed lung cancers, including multiple primary tumors
• Data are contained in two datasets: Participant and Lung Cancer
• Data were collected on the following forms:
  • LSS DE (PDF - 183 KB)
  • ACRIN ZX (ACRIN NLST CRF Set)
  • ACRIN ZL (ACRIN NLST CRF Set)

Available Data

• Cancer confirmation status (confirmation, report only, no cancer, etc.)
• Days from randomization to diagnosis
• Study year of diagnosis
• ICD-O-3 code
• Histopathologic type
• Grade
• Location(s) of tumor
• Size of tumor
• Staging data
  • Stage (Pathologic, Clinical, Combined; AJCC 6 and AJCC 7)
  • TNM components of stage (pathologic, clinical)
  • VALCSG stage (for small cell lung cancers)

In addition to lung cancer, the NLST confirmed diagnoses of non-lung cancer. This was mostly to ensure accurate ascertainment of lung cancer status and cause of death, but the data on non-lung cancer are still valuable. Less details were collected about non-lung cancers than lung cancers.

The NLST confirmed diagnoses of non-lung cancer through medical record abstraction (MRA) of participants suspected by the trial to have non-lung cancer. MRA was triggered by:

• self-report of non-lung cancer on a study update form (annual for LSS, semi-annual for ACRIN)
• death certificate indicating non-lung cancer
• a relative informing the screening center of a participant's cancer (this was infrequent)
• suspicion of lung cancer that was determined (by MRA) to be non-lung cancer (e.g. metastasis to the lung)

Note that if the MRA process did not find records indicating a diagnosis of non-lung cancer, the cancer was not considered confirmed, even if a source such as a death certificate indicated non-lung cancer.

Data collection was pursued for all non-lung cancers diagnosed at any time during the NLST trial period (except for basal and squamous cell skin cancers). This included additional primary cancers of a non-lung site that were diagnosed after the first cancer at that site.

ACRIN and LSS collected different information on non-lung cancer. ACRIN collected data on each pathology specimen obtained during diagnostic work-up of suspected cancer, while LSS recorded data about each tumor rather than pathology specimen. The ACRIN and LSS data were then harmonized to provide trial-wide, tumor-specific data. This entailed summarizing the ACRIN pathology specimen data to tumor-level through a review of the data. The trial-wide data includes the ICD-O-3 code and days from randomization to diagnosis for each tumor.

Because the non-lung cancer data was not a focus of NLST, these data are only available by special request. If you would like to obtain non-lung cancer data, please indicate your request in the section of the application labeled "Please explain if any additional data is needed and why."

Summary

• Data are available by special request only
• ~4,800 participants were diagnosed with non-lung cancer during NLST
• Data are available for all confirmed lung cancers, including multiple primary tumors
• Data were collected on the following forms:
  • LSS CDF (PDF - 110 KB)
  • LSS DE (PDF - 183 KB)
  • ACRIN ZP (ACRIN NLST CRF Set)
  • ACRIN ZD (ACRIN NLST CRF Set)

Available Data

• Days from randomization to diagnosis
• ICD-O-3 code
  • Topography
  • Morphology
  • Behavior
  • Grade
• SEER site categorization (derived from ICD-O-3 code)