Circulating Tumour DNA (ctDNA) Rectal Cancer and the Relationship to Extramural Venous Invasion (ctDNA)
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|ClinicalTrials.gov Identifier: NCT02579278|
Recruitment Status : Recruiting
First Posted : October 19, 2015
Last Update Posted : November 17, 2017
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 chosen if they demonstrate mrEMVI on their baseline MRI scan. 20 patients who become mrEMVI positive (following pre-operative therapy) and 20 patients who are mrEMVI negative will have blood samples taken before and 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.
|Condition or disease||Intervention/treatment|
|Cancer Rectal Cancer||Other: Blood sample (mrEMVI positive patient) Other: Blood sample (mrEMVI negative patient)|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Circulating Tumour DNA (ctDNA) Rectal Cancer and the Relationship to Extramural Venous Invasion (ctDNA Trial)|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
mrEMVI positive rectal tumours
20 patients will be registered whose rectal tumours are mrEMVI positive (i.e. EMVI is present in baseline and post-chemoradiotherapy MRI scans).
Other: Blood sample (mrEMVI positive patient)
Two blood samples are taken from each patient with mrEMVI positive tumours post chemoradiotherapy. One pre-surgery and one during surgery from a peripheral vein.
mrEMVI negative rectal tumours
20 patients registered who were mrEMVI positive at baseline MRI but have become mrEMVI negative post-chemoradiotherapy.
Other: Blood sample (mrEMVI negative patient)
Other Name: Two blood samples are taken from each patient with mrEMVI negative tumours post chemoradiotherapy. One pre-surgery and one during surgery from a peripheral vein.
- 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
20 patients with mrEMVI positive and 20 patients with mrEMVI negative tumours, that were both mrEMVI positive at baseline, are selected for the trial.
Each patient will have two blood samples taken that will be analysed for ctDNA. One blood sample will be taken at the time of preoperative assessment, after chemoradiotherapy, and a further sample will be taken intraoperatively, from the peripheral vein of the patient's arm. For each of the blood samples the presence or absence of ctDNA mutations (kras and p53) will be identified.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579278
|Contact: Lisa Scerrifirstname.lastname@example.org|
|Contact: Muhammed Siddiquiemail@example.com|
|Queen Elizabeth the Queen Mother Hospital||Recruiting|
|Margate, Kent, United Kingdom, CT9 4AN|
|Contact: Sharon Turney firstname.lastname@example.org|
|Principal Investigator: Jess Evans|
|St Mary's Hospital (Imperial)||Recruiting|
|Hammersmith, London, United Kingdom, W2 1NY|
|Contact: Afeez Adebesin email@example.com|
|Principal Investigator: James Kinross|
|Royal Marsden Hospital NHS Foundation Trust||Recruiting|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Contact: Gina Brown 442089156067 firstname.lastname@example.org|
|Contact: Lisa Ms Scerri 442089156067 email@example.com|
|Principal Investigator: Gina Brown|
|Principal Investigator:||Gina Brown||Consultant Radiologist & Professor of Cancer Imaging, Royal Marsden Hospital|