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Diagnosis; Objective RespOnse; THErApy

Study acronym: DOROTHEA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 31, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jul 31, 2023 to Jul 31, 2026 Completion date: Apr 30, 2024 to Apr 30, 2027v3 Show 1 more changeShow less
    • Completion date: Apr 30, 2024 to Apr 30, 2027
  2. Re-verified, no change to tracked fieldsv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Thi is a prospective and low-intervention clinical trial. We propose to design a panel of "core" genetic alterations by sequencing Cerebral Spinal Fluid (CSF) DNA in patients with confirmed or suspicious Primary Central Neurvous System Lymphoma (PCNSL) with the aim to improve diagnostic sensitivity, response assessment and monitoring early CNS relapse in routine practice. Enrolled patients will receive conventional treatments according to well-established international guidelines, DNA assessments will not influence the treatment choices.
Trial Details
NCT Number NCT05036564
Lead Sponsor IRCCS San Raffaele
Collaborators: Teresa Calimeri, Sara Steffanoni
Conditions Primary CNS Lymphoma
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov