Cancer Diagnosis

The PLCO trial confirmed diagnoses of prostate cancer through medical record abstraction (MRA) of men suspected by the trial to have prostate cancer. MRA was triggered by:

• A self-report of prostate cancer on an Annual Study Update (ASU)
• Abnormal suspicious PSA or DRE screening
• Death certificate indicates prostate cancer
• No trial indication of prostate cancer, but Death Review Committee suspects prostate cancer based on other indicators
• Relative informs screening center of participant's cancer (this is infrequent)

Note that if the MRA process does not find records indicating prostate cancer diagnosis, even if a source such as a death certificate indicates prostate cancer, the prostate cancer is not considered confirmed.

Clinical stage is almost always available (99% of prostate cancers). Pathologic stage is only available for men who had a prostatectomy (36% of prostate cancers).

Gleason scores were collected from both biopsies (98%) and prostatectomies (36%) and assessed at pathology labs local to the screening center. Gleason information was only captured on a 2 to 10 scale; primary and secondary Gleason scores were not captured individually.

Cancer diagnosis data can be obtained within the Prostate dataset.

Summary

• Data for ~8800 cancers (2100 screen-detected)
• Intervention arm statistics:
  • ~4600 cancers
  • Median age at dx: 69
  • Median years into study at dx: 5.3
• Control Arm Statistics:
  • ~4200 cancers
  • Median age at dx: 70
  • Median years into study at dx: 6.3

Available Data

• Cancer confirmation status (confirmation, report only, no cancer, etc.)
• Days from randomization to diagnosis
• Screen-detected versus not screen-detected
• Staging: Clinical, Path, Combined
• Gleason: Biopsy, Prostatectomy, Combined
• PSA level closest to diagnosis
• Histology

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

• A self-report of lung cancer on an Annual Study Update (ASU)
• Abnormal suspicious chest x-ray screening
• Death certificate indicates chest x-ray cancer
• No trial indication of lung cancer, but Death Review Committee suspects lung cancer based on other indicators
• Relative contacts screening center and informs it of participant's cancer (this is infrequent)

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

Cancer diagnosis data can be obtained within the Lung dataset.

Summary

• ~3700 lung cancers (300 screen-detected)
• Intervention arm statistics:
  • ~1900 cancers
  • Median age at dx: 71
  • Median years into study at dx: 6.8
• Control arm statistics:
  • ~1800 cancers
  • Median age at dx: 71
  • Median years into study at dx: 6.9

Available Data

• Cancer confirmation status (confirmation, report only, no cancer, etc.)
• Days of randomization to diagnosis
• Screen-detected versus not screen-detected
• Staging
• Histology

This section concerns collection of data for colorectal cancer only. For polyp and adenoma data collection, see Diagnostic Procedures (Colorectal).

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

• A self-report of colorectal cancer on an Annual Study Update (ASU)
• Abnormal suspicious FSG screening
• Death certificate indicates colorectal cancer
• No trial indication of colorectal cancer, but Death Review Committee suspects colorectal cancer based on other indicators
• Relative informs screening center of participant's cancer (this is infrequent)

Note that if the MRA process does not find records indicating colorectal cancer diagnosis, even if a source such as a death certificate indicates colorectal cancer, the colorectal cancer is not considered confirmed.

Cancer diagnosis data can be obtained within the Colorectal dataset.

Summary

• Data for ~2400 cancers (300 screen-detected)
• Intervention arm statistics:
  • ~1000 cancers
  • Median age at dx: 70
  • Median years into study at dx: 5.3
• Control arm statistics:
  • ~1300 cancers
  • Median age at dx: 70
  • Median years into study at dx: 5.8

Available Data

• Cancer confirmation status (confirmation, report only, no cancer, etc.)
• Days from randomization to diagnosis
• Screen-detected versus not screen-detected
• Tumor location (e.g., proximal, sigmoid)
• Cancer stage
• Histology

The PLCO trial confirmed diagnoses of ovarian cancer through medical record abstraction (MRA) of women whom the trial suspected to have ovarian cancer. Fallopian tube and primary paritoneal cancers as well as low malignant potential tumors were included along with invasive ovarian cancers. MRA was triggered by:

• A self-report of ovarian cancer on an Annual Study Update (ASU)
• Abnormal suspicious CA-125 or TVU screening
• Death certificate indicates ovarian cancer
• No trial indication of ovarian cancer, but Death Review Committee suspects ovarian cancer based on other indicators
• Relative contacts screening center and informs it of participant's cancer (this is infrequent)

Note that if the MRA process does not find records indicating ovarian cancer diagnosis, even if a source such as a death certificate indicates ovarian cancer, the ovarian cancer is not considered confirmed.

Cancer diagnosis data can be obtained within the Ovarian dataset.

Summary

• ~610 ovarian cancers (90 screen-detected)
• Intervention arm statistics:
  • ~330 cancers
  • Median age at dx: 70
  • Median years into study at dx: 7.2
• Control arm statistics:
  • ~280 cancers
  • Median age at dx: 71
  • Median years into study at dx: 7.9

Available Data

• Cancer confirmation status (confirmation, report only, no cancer, etc.)
• Days of randomization to diagnosis
• Screen-detected versus not screen-detected
• Staging: Clinical, Path, Combined
• Histology
• CA-125 level closest to diagnosis