Circulating Tumour DNA (ctDNA) Rectal Cancer and the Relationship to Extramural Venous Invasion (ctDNA)
In almost one third of patients with rectal cancer, cancer spreads through the bowel wall into nearby veins which can be seen on MRI scans and is known as mrEMVI. It has been observed that this is linked with worse survival due to the spread of cancer to the liver and other organs. The investigators think that this may occur by spread of cancer cells in the blood stream. Circulating cell-free tumour DNA (ctDNA) can be detected in the blood of patients with both metastatic and primary carcinoma (but not healthy individuals).
This trial does not interfere with the patient's routine treatment pathway. Participants will be grouped into whether or not they demonstrate mrEMVI on their post-radiotherapy MRI scan. 20 patients who are mrEMVI positive and 20 patients who are mrEMVI negative will have blood samples taken pre-surgery and then again during surgery and a comparison will be made between the two groups. If the investigators can find a link between the cancer cells seen in blood to mrEMVI they may be able to use this test to help guide treatment in the future. This study will serve as the feasibility of a larger, comparative study.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Circulating Tumour DNA (ctDNA) Rectal Cancer and the Relationship to Extramural Venous Invasion (ctDNA Trial)|
- To measure the presence or absence of ctDNA post CRT in EMVI-positive rectal cancer. [ Time Frame: 2 years ]
- To document the % mutation frequency [ Time Frame: 2 years ]
- Comparison of levels of measured ctDNA intraoperatively between mrEMVI positive and mrEMVI negative tumours. [ Time Frame: 2 years ]
- Comparison of % mutation frequency of ctDNA intraoperatively between mrEMVI negative and mrEMVI positive tumours. [ Time Frame: 2 years ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||November 2015|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
20 patients will be registered whose rectal tumours are persistently mrEMVI positive (i.e. EMVI is present in baseline and post-chemoradiotherapy MRI scans) and 20 patients registered who are persistently mrEMVI negative (i.e. EMVI is NOT present in baseline and post-chemoradiotherapy MRI scans)
Other: Blood sample
Three blood samples are taken from each patient. Two from the arm (one pre-surgery and one during surgery) and one from the resected tumour specimen vein.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02579278
|Contact: Lisa Scerriemail@example.com|
|Contact: Muhammed Siddiquifirstname.lastname@example.org|
|Royal Marsden Hospital NHS Foundation Trust|
|London/Surrey, Surrey, United Kingdom, SM2 5PT|
|Principal Investigator:||Gina Brown||Consultant Radiologist & Professor of Cancer Imaging, Royal Marsden Hospital|