Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

Pancreas Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04821219
• Other study ID #: 20-010804
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of the successful establishment of pancreatic patient-derived tumoroids (PDT)		2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years

External Links

•   Mayo Clinic Clinical Trials