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Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Notable Phase: Not applicable to Not specifiedv8 Show 9 more changesShow less
    • Trial status: Withdrawn to Enrolling by Invitation
    • Primary and study completion dates: Dec 30, 2028 to Dec 30, 2030
    • Primary endpoint revised
    • Enrollment target: 0 to 500
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2025 to Jan 31, 2024
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints expanded, about 45 words
    • Study description shortened, about 198 words
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Stopped Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: Larger study planned
    • Enrollment target: estimated 20 to confirmed 0
    • Primary and study completion dates: Dec 30, 2023 to Dec 30, 2028
    • Start date: Mar 15, 2023 to Dec 2025
    v6
  4. Notable Primary completion date: Sep 30, 2022 to Dec 30, 2023
    • Start date: Feb 15, 2022 to Mar 15, 2023
    • Study completion date: Dec 30, 2022 to Dec 30, 2023
    v5
  5. Notable Primary completion date: Sep 30, 2021 to Sep 30, 2022
    • Start date: Apr 1, 2021 to Feb 15, 2022
    • Study completion date: Oct 30, 2021 to Dec 30, 2022
    v4
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  1. Notable Phase: Not specified to Not applicable
    • Study arms: 0 to 1
    v3
  2. Minor Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions. The test involves ultrasound and an analysis of pancreatic juice. A neural network-based computer-assisted system may be utilized to enhance the analysis. Patients enrolled are being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes).
Trial Details
NCT Number NCT04793633
Lead Sponsor Adenocyte, LLC
Conditions
(from sponsor)
Pancreatic Ductal Adenocarcinoma
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov