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Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection

Study acronym: MCN_Tam
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 24 words Secondary endpoints: details revised at 1 of 1 entry Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Primary completion date: Nov 2026 to Nov 2028 Completion date: May 2027 to May 2029v9 Show 1 more changeShow less
    • Completion date: May 2027 to May 2029
  3. Study description expanded, about 36 wordsv8 See this version in full on ClinicalTrials.gov ↗
  4. Secondary endpoints: details revised at 1 of 1 entry Eligibility criteria shortened, about 4 words · Study description shortened, about 2 wordsv7 Show 2 more changesShow less
    • Eligibility criteria shortened, about 4 words
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2025 to Jan 22, 2025 · Site details revisedv6 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2025 to Jan 22, 2025
    • Site details revised
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Nov 2024 to Jan 2025v5
  2. Start date: Sep 2024 to Nov 2024v4
  3. Start date: May 2024 to Sep 2024 Eligibility criteria shortened, about 7 words · Study description expanded, about 6 wordsv3 Show 2 more changesShow less
    • Eligibility criteria shortened, about 7 words
    • Study description expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Pancreatic mucinous cystic neoplasm (MCN) is a precursor to invasive pancreatic adenocarcinoma which occurs almost exclusively in females in their 5th-7th decade. Currently the only option for MCN treatment and prevention of invasive pancreatic ductal adenocarcinoma (PDA) is oncologic resection. The clinical features of pancreatic MCN support the influence of sex hormones in the pathogenesis of the disease. Anti-hormonal therapy may therefore constitute an effective approach to treatment. Preliminary analyses from preclinical studies suggest that tamoxifen inhibits the spread and normal life cycle in MCN epithelial cells and fibroblasts. Investigators hypothesize that in humans, treatment with tamoxifen will lead to cyst regression or stabilization and may spare or delay the need for resection. Up to 15 participants not undergoing immediate resection will be enrolled and take tamoxifen orally for up to 24 weeks. The study will assess the feasibility of tamoxifen as a treatment for pancreatic MCN.
Trial Details
NCT Number NCT06320990
Lead Sponsor University of Nebraska
Conditions Pancreatic Cyst, Pancreatic Mucinous Cystic Neoplasm
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov