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Personalized First-line Chemotherapy Choice in Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures

Study acronym: PACsign
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Enrollment closed, study ongoing Show 5 more changesShow less
    • Enrollment target: estimated 85 to confirmed 79
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 7 of 7 sites
    • Study description expanded, about 4 words
  2. Minor Site details revised at 2 of 7 sitesv10
  3. Minor Enrollment target: 62 to 85
    • Study sites: 6 to 7
    • Study title shortened, about 1 word
    v9
  4. Minor Study title expanded, about 1 wordv8
  5. Notable Primary and study completion dates: Dec 11, 2026 to Dec 11, 2028
    • Study sites: 5 to 6
    v7
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  1. Minor Re-verified, no change to tracked fieldsv6
  2. Notable Primary completion date: Oct 14, 2025 to Dec 11, 2026
    • Study sites: 3 to 5
    • Study completion date: Dec 15, 2026 to Dec 11, 2026
    • Eligibility criteria expanded, about 4 words
    v5
  3. Notable Primary completion date: Jan 30, 2024 to Oct 14, 2025
    • Study completion date: Mar 30, 2025 to Dec 15, 2026
    v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 30, 2022 to Dec 12, 2022
    • Site details revised at 3 of 3 sites
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients.
Trial Details
NCT Number NCT05475366
Lead Sponsor Institut Curie
Conditions
(from sponsor)
Carcinoma, Pancreatic Ductal, Prognosis
Related terms Anophthalmia with pulmonary hypoplasia, Carcinoma, Pancreatic Ductal
Enrollment 79 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov