Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

NCT ID: NCT04821219

Last Updated: 2022-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Pancreas Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tumoroid generation

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

Group Type EXPERIMENTAL

Treatment prediction PDT platform

Intervention Type OTHER

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.

Interventions

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Treatment prediction PDT platform

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Panagiotis Z. Anastasiadis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Panagiotis Anastasiadis, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

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Other Identifiers

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20-010804

Identifier Type: -

Identifier Source: org_study_id

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