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NCT05334069

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
Track this trial

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Record History

All 28 versions: 28 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 747 → 751 locations
  2. Enrollment increased: 2000 → 2900 participants
    • Eligibility criteria expanded, about 50 words
    • Study description shortened, about 11 words
    • Site details revised at 1 of 747 sites
  3. Study sites: 745 to 747
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 1 of 1 entry
  4. Study sites: 744 to 745v25
  5. Study sites: 745 to 744v24
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 746 to 745v23
  2. Study sites revised (746)v22
  3. Study sites: 745 to 746v21
  1. Trial sites expanded: 740 → 745 locationsv20
  2. Primary completion pushed from Jan 31, 2026 to Jan 31, 2027
    • Site details revised at 8 of 740 sites
    v19
  3. Study sites: 737 to 740v18
  4. Study sites: 733 to 737v17
  5. Study sites: 730 to 733v16
  6. Study sites revised (730)v15
  7. Study sites: 695 to 730v14
  8. Study sites: 688 to 695v13
  9. Study completion date: Feb 2027 to Feb 28, 2027
    • Site details revised at 629 of 688 sites
    v12
  10. Primary completion date: Jan 31, 2025 to Jan 31, 2026
    • Study completion date: Feb 2025 to Feb 2027
    • Start date: Aug 1, 2022 to Aug 18, 2022
    • Site details revised at 629 of 688 sites
    v11
  11. Study sites: 685 to 688v10
  12. Study sites: 679 to 685v9
  13. Study sites: 669 to 679v8
  14. Study sites: 665 to 669v7
  15. Study sites: 659 to 665v6
  16. Study sites: 652 to 659v5
  17. Study sites: 642 to 652v4
  18. Study sites: 568 to 642v3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 568
    • Start date changed from estimate of Jun 2022 to Aug 1, 2022
    v2
  20. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Provision of blinded reference set of cancer versus non-cancer blood samples
Timeframe: Up to 1 year

Secondary (2)

Test performance at the time of initial cancer diagnosis by tumor type
Test performance at the time of initial cancer diagnosis by clinical stage

Arms and interventions

Screening (questionnaire, biospecimen collection)

Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.

Other: Questionnaire Administration

Procedures: Biospecimen Collection

Sites

751 sites in 1 country