Prediction of Neoadjuvant Chemotherapy Response in Pancreatic Cancer
Recruiting · NCT07226154 · Observational (researchers observe without assigning treatment) · Lead sponsor: City of Hope Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
PRECEPT assay (qRT-PCR validation)Small RNA sequencing
What this trial is about
This study aims to develop and validate a predictive microRNA (miRNA) panel to assess the response to neoadjuvant chemotherapy (NACT) in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Underwent neoadjuvant chemotherapy (FOLFIRINOX or Gemcitabine/nab-paclitaxel).
- Availability of pre-treatment plasma samples.
- Underwent curative-intent resection (R0 or R1).
Exclusion criteria
- Inadequate plasma samples or poor RNA quality for exosomal miRNA analysis.
- Non-adenocarcinoma histology.
- Presence of synchronous or multiple primary malignancies.
- Receipt of chemotherapy regimens other than standard FOLFIRINOX or gemcitabine plus nab-paclitaxel (GEM-NABP).
- Presence of active inflammatory or autoimmune diseases.
Where it is running
1 location listed across 1 US state.
- City of Hope Medical Center - Duarte, California, United States