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Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

Primary Purpose

Pancreas Adenocarcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treatment prediction PDT platform
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years of age.
  • Have an ECOG Performance Status of ≤ 2.
  • No evidence of distant metastasis on imaging.
  • Histologic or cytologic proven adenocarcinoma of the pancreas.
  • Providing informed consent prior to enrollment in the trial.

Exclusion Criteria:

  • Failure to obtain additional core needle biopsies for generating PDTs.
  • Females who are pregnant or plan to become pregnant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tumoroid generation

    Arm Description

    Single arm, including all the patients enrolled to generate tumor models

    Outcomes

    Primary Outcome Measures

    Rate of the successful establishment of pancreatic patient-derived tumoroids (PDT)

    Secondary Outcome Measures

    Drug sensitivity and response prediction of chemotherapy agents in PDT
    the PDT response to the treatment with conventional regimens for treatment of (pancreatic adenocarcinoma (PDAC) and other approved treatments based on pharmacogenomic analysis. Treatment response will be assessed with viability assays.
    Drug sensitivity and response prediction of radiation therapy in PDT
    the PDT response to the treatment with radiation with or without radiosensitizers. Treatment response will be assessed with viability assays.
    PDT validation with a comparative analysis of patients' response to neoadjuvant chemotherapy and radiation
    Response evaluation according to imaging based on RECIST (Response Evaluation Criteria in Solid Tumors) criteria, biochemical response in CA19-9 and pathologic response in the surgical specimen vs. PTD response in the corresponding neoadjuvant regimen.

    Full Information

    First Posted
    February 23, 2021
    Last Updated
    February 7, 2022
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04821219
    Brief Title
    Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids
    Official Title
    Establishing a Platform for Personalized Approach to the Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    study PI no longer at Institution
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is designed to prospectively investigate the feasibility of establishing patient-derived tumoroids (PDT) as a platform for a personalized approach for response prediction and guide optimal neoadjuvant and/or adjuvant approach. PDT will be investigated to determine drug sensitivity, predict the response to chemotherapy agents and radiation therapy, and validate this response in treated patients, and to establish the feasibility of PDT as a platform for a personalized approach to guide multimodality treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreas Adenocarcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tumoroid generation
    Arm Type
    Experimental
    Arm Description
    Single arm, including all the patients enrolled to generate tumor models
    Intervention Type
    Other
    Intervention Name(s)
    Treatment prediction PDT platform
    Intervention Description
    PDT will be generated and response to various chemotherapies and radiation will be investigated. Actionable targets will be identified and response to the target drug will be assessed and compared to the conventional treatment options.
    Primary Outcome Measure Information:
    Title
    Rate of the successful establishment of pancreatic patient-derived tumoroids (PDT)
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Drug sensitivity and response prediction of chemotherapy agents in PDT
    Description
    the PDT response to the treatment with conventional regimens for treatment of (pancreatic adenocarcinoma (PDAC) and other approved treatments based on pharmacogenomic analysis. Treatment response will be assessed with viability assays.
    Time Frame
    2 years
    Title
    Drug sensitivity and response prediction of radiation therapy in PDT
    Description
    the PDT response to the treatment with radiation with or without radiosensitizers. Treatment response will be assessed with viability assays.
    Time Frame
    2 years
    Title
    PDT validation with a comparative analysis of patients' response to neoadjuvant chemotherapy and radiation
    Description
    Response evaluation according to imaging based on RECIST (Response Evaluation Criteria in Solid Tumors) criteria, biochemical response in CA19-9 and pathologic response in the surgical specimen vs. PTD response in the corresponding neoadjuvant regimen.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years of age. Have an ECOG Performance Status of ≤ 2. No evidence of distant metastasis on imaging. Histologic or cytologic proven adenocarcinoma of the pancreas. Providing informed consent prior to enrollment in the trial. Exclusion Criteria: Failure to obtain additional core needle biopsies for generating PDTs. Females who are pregnant or plan to become pregnant.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Panagiotis Anastasiadis, PhD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

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