NCT04821219

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 23, 2021

Last Update Submit

February 7, 2022

Conditions

Pancreas Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (3)

  • Drug sensitivity and response prediction of chemotherapy agents in PDT

    2 years

  • Drug sensitivity and response prediction of radiation therapy in PDT

    2 years

  • PDT validation with a comparative analysis of patients' response to neoadjuvant chemotherapy and radiation

    2 years

Study Arms (1)

Tumoroid generation

EXPERIMENTAL

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

Other: Treatment prediction PDT platform

Interventions

Treatment prediction PDT platformOTHER

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.

Tumoroid generation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Panagiotis Anastasiadis, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 29, 2021

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share