Pancreas Adenocarcinoma
Conditions
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.
Interventions
OTHERTreatment 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of the successful establishment of pancreatic patient-derived tumoroids (PDT) | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed