Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04821219

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Adenocarcinoma	Other: Treatment prediction PDT platform	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Establishing a Platform for Personalized Approach to the Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tumoroid generation Single arm, including all the patients enrolled to generate tumor models	Other: 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.

Arm

Intervention/Treatment

Experimental: Tumoroid generation

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

Other: 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.

Outcome Measures

Primary Outcome Measures

Rate of the successful establishment of pancreatic patient-derived tumoroids (PDT) [2 years]

Secondary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Panagiotis Anastasiadis, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Panagiotis Z. Anastasiadis, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04821219

Other Study ID Numbers:

20-010804

First Posted:

Mar 29, 2021

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Feb 24, 2022