Examining blood samples in colorectal cancer patients to understand tumor spread
Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion
Imperial College London · NCT02579278
This study is testing if blood samples can help doctors understand how tumor spread relates to certain imaging features in patients with colorectal cancer who are about to have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 3 sites (Margate, Kent and 2 other locations) |
| Trial ID | NCT02579278 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between circulating tumor DNA (ctDNA) and imaging features of extramural venous invasion (EMVI) in patients with colorectal adenocarcinoma eligible for curative surgery. Eligible participants will provide two blood samples, one before surgery and another within 24 hours after, to assess the potential link between EMVI status and ctDNA. The study aims to follow patients for up to three years to gather data on disease progression and metastasis. No randomization or treatment is involved, focusing solely on observational data collection.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 years or older with biopsy-confirmed colorectal adenocarcinoma who are eligible for curative surgery and have no metastatic disease.
Not a fit: Patients with metastatic disease, synchronous second malignancies, or contraindications for imaging to determine EMVI status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how colorectal cancer spreads, potentially leading to improved diagnostic and treatment strategies.
How similar studies have performed: While the specific approach of linking ctDNA to EMVI status is novel, similar studies have shown promise in understanding cancer metastasis through blood biomarkers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Have a biopsy-confirmed colorectal adenocarcinoma 2. Is eligible for curative surgery 3. Has no metastatic disease on CT scan 4. Has completed pre-operative staging scan within six weeks prior to surgery 5. Have provided written informed consent to participate in the study 6. Be aged 16 years or over Exclusion Criteria: 1. Have metastatic disease (including resectable liver metastases) 2. Have a synchronous second malignancy 3. Are contraindicated for any imaging able to determine EMVI status
Where this trial is running
Margate, Kent and 2 other locations
- Queen Elizabeth the Queen Mother Hospital — Margate, Kent, United Kingdom (RECRUITING)
- St Mary's Hospital (Imperial) — Hammersmith, London, United Kingdom (RECRUITING)
- Royal Marsden Hospital NHS Foundation Trust — Sutton, Surrey, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Gina Brown, MD — Imperial College London
- Study coordinator: Caroline Martin
- Email: c.martin1@imperial.ac.uk
- Phone: +44 (0) 7749 655 817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Rectal Cancer, EMVI, Extramural Venous Invasion, mrEMVI, ctDNA, Neoplasm DNA, MRI