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Older Breast Cancer Patients: Risk for Cognitive Decline

Study acronym: TLC
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Apr 30, 2025 → Apr 30, 2027
See other at-risk trials from Georgetown University

Record History

  1. Primary and study completion pushed from Apr 30, 2025 to Apr 30, 2027 Eligibility criteria expanded, about 22 words · Secondary endpoints: details revised at 2 of 7 entries · Study description revised · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description revised
    • Publications: details revised at 6 of 6 entries
  2. Primary and study completion dates: Dec 31, 2023 to Apr 30, 2025v9
  3. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023v8
  4. Primary endpoints: 11 to 3 Study description expanded, about 8 wordsv7 Show 1 more changeShow less
    • Study description expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 1300 to 1700 Secondary endpoints revised (7) · Study description expanded, about 21 wordsv6 Show 2 more changesShow less
    • Secondary endpoints revised (7)
    • Study description expanded, about 21 words

    See this version in full on ClinicalTrials.gov ↗

Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting Primary and study completion dates: Dec 31, 2021 to Dec 31, 2022 · Site details revisedv5 Show 2 more changesShow less
    • Primary and study completion dates: Dec 31, 2021 to Dec 31, 2022
    • Site details revised
  2. Trial status: Recruiting to Active, Not Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  3. Re-verified, no change to tracked fieldsv3
  4. Enrollment target: 850 to 1300 Eligibility criteria expanded, about 24 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 24 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to evaluate the impact of systemic therapy on cognition in older breast cancer patients, explore change in APE, LM and Cognition domains, measure associations between cognitive decline and QOL, and describe how genetic polymorphisms, inflammatory biomarkers, sleep and physical measures moderate cognitive outcomes. This study is being done nationally, with recruiting sites at Georgetown University, Montgomery General Hospital, Virginia Cancer Specialists, Washington Hospital Center, Reston Breast Care Specialists, Memorial Sloan-Kettering, Moffitt Cancer Center, City of Hope National Medical Center, Hackensack University Medical Center, Indiana University and University of California, Los Angeles.
Trial Details
NCT Number NCT03451383
Lead Sponsor Georgetown University
Collaborators: Memorial Sloan Kettering Cancer Center, Indiana University, H. Lee Moffitt Cancer Center and Research Institute, City of Hope Medical Center, Hackensack Meridian Health
Conditions Cancer, Breast, Age-related Cognitive Decline, Cognitive Decline
Enrollment 1,700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov