Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

Not Applicable

Withdrawn

• Conditions: Pancreas Adenocarcinoma
• Interventions: Other: Treatment prediction PDT platform

• Registration Number: NCT04821219
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-29
• Study Start: 2022-01-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-24
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumoroid generation	Treatment prediction PDT platform	Single arm, including all the patients enrolled to generate tumor models

Primary Outcome Measures

Name	Time	Method
Rate of the successful establishment of pancreatic patient-derived tumoroids (PDT)	2 years

Secondary Outcome Measures

Name	Time	Method
PDT validation with a comparative analysis of patients' response to neoadjuvant chemotherapy and radiation	2 years	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.
Drug sensitivity and response prediction of radiation therapy in PDT	2 years	the PDT response to the treatment with radiation with or without radiosensitizers. Treatment response will be assessed with viability assays.
Drug sensitivity and response prediction of chemotherapy agents in PDT	2 years	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.