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Circulating Tumour DNA (ctDNA) Rectal Cancer and the Relationship to Extramural Venous Invasion (ctDNA)

This study is currently recruiting participants.
Verified March 2017 by Royal Marsden NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02579278
First Posted: October 19, 2015
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
  Purpose

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 Intervention
Cancer Rectal Cancer Other: Blood sample (mrEMVI positive patient) Other: Blood sample (mrEMVI negative patient)

Study Type: Observational
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)

Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • To measure the presence or absence of ctDNA post CRT in EMVI-positive rectal cancer. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 patients with persistently mrEMVI positive rectal tumours and 20 patients with persistently mrEMVI negative rectal tumours
Criteria

Inclusion Criteria:

  • High-risk patients with biopsy proven rectal adenocarcinoma who will undergo long-course chemoradiotherapy (CRT) and who are potentially eligible for curative surgery
  • Patients who have persistently (i.e. in baseline and post-treatment MRI) mrEMVI positive (with superior rectal vein invasion) or mrEMVI negative tumours.
  • Patients aged over 18 years
  • Negative (on CT) for metastatic disease

Exclusion Criteria:

  • Under 18 years of age
  • Patients with any metastatic disease
  • Patients with a synchronous second malignancy
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Lisa Scerri +442089156067 lisa.scerri@gmail.com
Contact: Muhammed Siddiqui md0u812a@mac.com

Locations
United Kingdom
Queen Elizabeth the Queen Mother Hospital Recruiting
Margate, Kent, United Kingdom, CT9 4AN
Contact: Sharon Turney       sharon.turney@nhs.net   
Principal Investigator: Jess Evans         
St Mary's Hospital (Imperial) Recruiting
Hammersmith, London, United Kingdom, W2 1NY
Contact: Afeez Adebesin       afeez.adebesin@nhs.net   
Principal Investigator: James Kinross         
Royal Marsden Hospital NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Gina Brown    442089156067    gina.brown@rmh.nhs.uk   
Contact: Lisa Ms Scerri    442089156067    lisa.scerri@rmh.nhs.uk   
Principal Investigator: Gina Brown         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Gina Brown Consultant Radiologist & Professor of Cancer Imaging, Royal Marsden Hospital
  More Information

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02579278     History of Changes
Other Study ID Numbers: CCR 4121
First Submitted: October 6, 2015
First Posted: October 19, 2015
Last Update Posted: November 15, 2017
Last Verified: March 2017

Keywords provided by Royal Marsden NHS Foundation Trust:
EMVI
Extramural Venous Invasion
mrEMVI
Rectal Cancer
ctDNA
Neoplasm DNA
MRI

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases