deltatrials
Active Not Recruiting OBSERVATIONAL NCT00339495

Prostate Lung Colorectal and Ovarian (PLCO) Cancer Screening Trial

Sponsor: National Cancer Institute (NCI)

Conditions Cancer Death
Updated 70 times since 2017 Last updated: Apr 28, 2026 Started: May 1, 1998 Primary completion: Dec 31, 2026 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Cancer and Death and is currently ongoing. National Cancer Institute (NCI) leads this study, which shows 70 recorded versions since 1998 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

The Division of Cancer Preventionl (DCP, formerly DCPC), under extramural contracts to 10 U.S. clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal and ovarian cancer (The PLCO Trial). In 1996 the NCI Executive Committee approved the expansion of the PLCO Trial to collect additional materials and to conduct additional studies. About, 74,000 men and 74,000 women, aged 55-74 years, have been randomized on a 50/50 basis into screening or usual care arms. Additional blood is collected from screened subjects and saliva for buccal cells from control subjects. Pathologic tissues are obtained for selected cases that develop cancer or selected related diseases (e.g. colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk and disease-related information is also collected, with confirmation of disease status from medical records. Genetic, biochemical and questionnaire-based risk information will be related to the development of cancer and other diseases in this population. Volunteers who provide samples for these studies will not routinely receive their individual results from the Additional Investigation. Subjects requesting such information, however, will be provided their test results. In 2009 the NCI Executive Committee approved the Extended Follow-up of subjects beyond the original 13-year follow-up period. Participants will be reconsented for...

The Division of Cancer Preventionl (DCP, formerly DCPC), under extramural contracts to 10 U.S. clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal and ovarian cancer (The PLCO Trial). In 1996 the NCI Executive Committee approved the expansion of the PLCO Trial to collect additional materials and to conduct additional studies. About, 74,000 men and 74,000 women, aged 55-74 years, have been randomized on a 50/50 basis into screening or usual care arms. Additional blood is collected from screened subjects and saliva for buccal cells from control subjects. Pathologic tissues are obtained for selected cases that develop cancer or selected related diseases (e.g. colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk and disease-related information is also collected, with confirmation of disease status from medical records. Genetic, biochemical and questionnaire-based risk information will be related to the development of cancer and other diseases in this population. Volunteers who provide samples for these studies will not routinely receive their individual results from the Additional Investigation. Subjects requesting such information, however, will be provided their test results. In 2009 the NCI Executive Committee approved the Extended Follow-up of subjects beyond the original 13-year follow-up period. Participants will be reconsented for the release of records to a single NCI-Designated Central Data Collection Center (CDCC), which will administer the annual mailings containing the annual study update questionnaire and a brief (1-2 page) risk factor questionnaire. Individuals who do not consent to release their identifiers to the CDCC will be followed up passively through linkage to state cancer registries and the National Death Index.

This protocol Review Application is for (1) the collaboration of intramural scientists in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies and (2) the coordination, in collaboration with DCP, of the Extended Follow-up.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~May 2019 · 6 months · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Jan 2020 · 2 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Dec 2020 · 3 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Oct 2021 · 5 months · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Feb 2022 · 2 months · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Jan 2023 · 2 months · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Jun 2023 · 2 months · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Dec 2024 · 2 months · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Jan 2026 · 6 months · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – ~May 2026 · 2 months · monthly snapshotMay 4, 2026 – present · 2 months · daily API

Change History

70 versions recorded
  1. May 4, 2026 — Present [daily]

    Active Not Recruiting

  2. Mar 2026 — May 2026 [monthly]

    Active Not Recruiting

  3. Feb 2026 — Mar 2026 [monthly]

    Active Not Recruiting

  4. Jan 2026 — Feb 2026 [monthly]

    Active Not Recruiting

  5. Jul 2025 — Jan 2026 [monthly]

    Active Not Recruiting

Show 65 earlier versions
  1. Jun 2025 — Jul 2025 [monthly]

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  2. May 2025 — Jun 2025 [monthly]

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  3. Apr 2025 — May 2025 [monthly]

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  4. Mar 2025 — Apr 2025 [monthly]

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  5. Feb 2025 — Mar 2025 [monthly]

    Active Not Recruiting

  6. Jan 2025 — Feb 2025 [monthly]

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  7. Dec 2024 — Jan 2025 [monthly]

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  8. Oct 2024 — Dec 2024 [monthly]

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  9. Sep 2024 — Oct 2024 [monthly]

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  10. Jul 2024 — Sep 2024 [monthly]

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  11. Jun 2024 — Jul 2024 [monthly]

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  12. May 2024 — Jun 2024 [monthly]

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  13. Apr 2024 — May 2024 [monthly]

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  14. Mar 2024 — Apr 2024 [monthly]

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  15. Feb 2024 — Mar 2024 [monthly]

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  16. Jan 2024 — Feb 2024 [monthly]

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  17. Dec 2023 — Jan 2024 [monthly]

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  18. Nov 2023 — Dec 2023 [monthly]

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  19. Oct 2023 — Nov 2023 [monthly]

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  20. Sep 2023 — Oct 2023 [monthly]

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  21. Aug 2023 — Sep 2023 [monthly]

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  22. Jul 2023 — Aug 2023 [monthly]

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  23. Jun 2023 — Jul 2023 [monthly]

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  24. Apr 2023 — Jun 2023 [monthly]

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  25. Mar 2023 — Apr 2023 [monthly]

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  26. Feb 2023 — Mar 2023 [monthly]

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  27. Jan 2023 — Feb 2023 [monthly]

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  28. Nov 2022 — Jan 2023 [monthly]

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  29. Sep 2022 — Nov 2022 [monthly]

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  30. Jul 2022 — Sep 2022 [monthly]

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  31. Jun 2022 — Jul 2022 [monthly]

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  32. May 2022 — Jun 2022 [monthly]

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  33. Apr 2022 — May 2022 [monthly]

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  34. Feb 2022 — Apr 2022 [monthly]

    Active Not Recruiting

  35. Dec 2021 — Feb 2022 [monthly]

    Active Not Recruiting

  36. Nov 2021 — Dec 2021 [monthly]

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  37. Oct 2021 — Nov 2021 [monthly]

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  38. May 2021 — Oct 2021 [monthly]

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  39. Apr 2021 — May 2021 [monthly]

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  40. Jan 2021 — Apr 2021 [monthly]

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  41. Dec 2020 — Jan 2021 [monthly]

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  42. Sep 2020 — Dec 2020 [monthly]

    Active Not Recruiting

  43. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting

  44. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting

  45. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting

  46. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting

  47. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting

  48. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting

  49. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting

  50. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting

  51. Nov 2019 — Jan 2020 [monthly]

    Active Not Recruiting

  52. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting

  53. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting

  54. Aug 2019 — Sep 2019 [monthly]

    Active Not Recruiting

  55. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting

  56. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting

  57. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting

  58. Nov 2018 — May 2019 [monthly]

    Active Not Recruiting

  59. Oct 2018 — Nov 2018 [monthly]

    Active Not Recruiting

  60. Sep 2018 — Oct 2018 [monthly]

    Active Not Recruiting

  61. Jul 2018 — Sep 2018 [monthly]

    Active Not Recruiting

  62. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting

  63. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting

  64. Apr 2018 — May 2018 [monthly]

    Active Not Recruiting

    Phase: NANone

  65. Jan 2017 — Apr 2018 [monthly]

    Active Not Recruiting NA

    First recorded

May 1998

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

The Division of Cancer Preventionl (DCP, formerly DCPC), under extramural contracts to 10 U.S. clinical centers, is evaluating the effectiveness of screening for prostate, lung, colorectal and ovarian cancer (The PLCO Trial). In 1996 the NCI Executive Committee approved the expansion of the PLCO Trial to collect additional materials and to conduct additional studies. About, 74,000 men and 74,000 women, aged 55-74 years, have been randomized on a 50/50 basis into screening or usual care arms. Additional blood is collected from screened subjects and saliva for buccal cells from control subjects. Pathologic tissues are obtained for selected cases that develop cancer or selected related diseases (e.g. colon polyps, benign prostatic hyperplasia). Additional questionnaire-based risk and disease-related information is also collected, withconfirmation of disease status from medical records. Genetic, biochemical and questionnairebasedrisk information will be related to the development of cancer and other diseases in this population. Volunteers who provide samples for these studies will not routinely receive their individual results from the Additional Investigation. Subjects requesting such information, however, will be provided their test results. In 2009 the NCI Executive Committee approved the Extended Follow-up of subjects beyond the original 13-year follow-up period. Participants will be reconsented for the release of records to a single NCI-Designated Central Data Collection Center (CDCC), which will administer the annual mailings containing the annual study update questionnaire and a brief (1-2 page) risk factor questionnaire. Individuals who do not consent to release their identifiers to the CDCC will be followed up passively through linkage to state cancer registries and the National Death Index. This protocol Review Application is for (1) the collaboration of intramural scientists in the Division of Cancer Epidemiology and Genetics (DCEG) in the Additional Studies and (2) the coordination, in collaboration with DCP, of the Extended Follow-up....

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations