RecruitingNCT07226154

Prediction of Neoadjuvant Chemotherapy Response in Pancreatic Cancer

An Exosomal miRNA Based Predictive Model for Personalized Neoadjuvant Chemotherapy Selection in Pancreatic Ductal Adenocarcinoma


Sponsor

City of Hope Medical Center

Enrollment

200 participants

Start Date

Nov 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This research study analyzes stored blood samples from people with pancreatic cancer to see if tiny molecules called microRNAs (found in particles released by tumor cells) can predict how well someone responded to chemotherapy given before surgery. It is not a treatment trial — it uses samples already collected. **You may be eligible if...** - You have been confirmed to have pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) - You received chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) before surgery - Blood samples were taken before your treatment started - You had surgery with the intent to remove the tumor **You may NOT be eligible if...** - Your blood samples are unavailable or of poor quality - You have a different type of pancreatic cancer (not adenocarcinoma) - You have or had another primary cancer at the same time - You received a non-standard chemotherapy regimen - You have an active inflammatory or autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSmall RNA sequencing

High-throughput small RNA sequencing performed on pre-treatment plasma samples from PDAC patients in the Discovery cohort to identify candidate microRNAs associated with neoadjuvant chemotherapy response. Sequencing data were analyzed to detect differentially expressed miRNAs between responder (CR + PR + SD) and non-responder (PD) groups.

DIAGNOSTIC_TESTPRECEPT assay (qRT-PCR validation)

Quantitative reverse transcription PCR (qRT-PCR)-based validation assay performed on pre-treatment plasma samples in the Training and Validation cohorts. Candidate microRNAs identified in the Discovery cohort by small RNA sequencing were tested using the PRECEPT assay to develop and validate a predictive miRNA panel for neoadjuvant chemotherapy response.


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT07226154


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