What this study is
The EpiDRIVE study aims to identify cfDNA-based epigenetic determinants of response in metastatic colorectal cancer (mCRC) patients treated with EGFR- or VEGF-targeted therapy.
By integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to develop a predictive biomarker panel capable of differentiating responders from non-responders to targeted therapy.
What's being tested
- cfDNA 5mC/5hmC Sequencing (EpiDRIVE Discovery Phase)
Intervention · DIAGNOSTIC TEST
High-throughput genome-wide sequencing of cfDNA methylation (5mC) and hydroxymethylation (5hmC) profiles from pre-treatment plasma samples in the discovery cohort to identify epigenetic determinants of targeted-therapy response (PFS ≥ 12 months vs < 12 months).
- EpiDRIVE Assay (Targeted Sequencing / qPCR Validation)
Intervention · DIAGNOSTIC TEST
Targeted sequencing or qPCR-based validation of cfDNA 5mC/5hmC markers identified from the discovery phase to develop and validate a predictive biomarker model discriminating patients with long vs short progression-free survival after EGFR-/VEGF-targeted therapy.
Study details
- Official title
- Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Identify Determinants of Response In VEGF/EGFR-targeted Therapy for Metastatic Colorectal Cancer
- Sponsor
- City of Hope Medical Center
- Conditions
- CRC (Colorectal Cancer)
- Enrolling
- 500 people
- Starts
- 2024-06-21
- Est. completion
- 2028-06-18
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Histologically confirmed metastatic colorectal adenocarcinoma (mCRC).
- Received EGFR-targeted therapy (cetuximab/panitumumab) or VEGF-targeted therapy (bevacizumab).
- Availability of pre-treatment plasma sample for cfDNA analysis.
- Documented radiologic response evaluation (RECIST 1.1).
- RAS/BRAF mutation status known.
You can't join if
- Inadequate cfDNA quality or low cfDNA yield.
- Non-adenocarcinoma histology.
- Concurrent or prior other active malignancy.
- Active inflammatory or autoimmune disease affecting cfDNA methylation profiles.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCity of Hope Medical Center
Duarte, California, United States
- Ajay Goel, PhD · Contact626-218-3452ajgoel@coh.org
Recruiting
Study team
Sponsor
City of Hope Medical Center
Study ID 23228/EpiDRIVE
Principal investigator
Ajay Goel, PhD
City of Hope Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.