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Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer (TRACC)

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.
 
ClinicalTrials.gov Identifier: NCT04050345
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
This is a multi-centre, prospective, translational research study involving the collection and analysis of tumour tissue, serial blood samples and clinical data in patients with newly diagnosed stage I, II and III CRC. The study will also include collection and analysis of tissue, serial blood samples and clinical data of patients with newly diagnosed stage I CRC.

Condition or disease
Colorectal Cancer

Detailed Description:
Circulating cell free tumour DNA (ctDNA) maintains the same mutations that are present in tumour. In colorectal cancer, primary tumours & metastases exhibit high genomic concordance. Therefore the TRACC study is investigating whether in patients with stage II and III colorectal cancer that have undergone potentially curative surgery, blood samples to detect & quantify ctDNA may identify minimal residual disease and relapse earlier than existing methods. CtDNA may ultimately help identify a subset of patients that are or are unlikely to benefit from adjuvant chemotherapy and could therefore safely spare some patients from receiving unnecessary chemotherapy & its associated side-effects.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer
Actual Study Start Date : December 5, 2016
Estimated Primary Completion Date : December 5, 2024
Estimated Study Completion Date : December 5, 2024

Group/Cohort
Colon
Patients who have a diagnosis of large bowel cancer (in the colon) and the cancer is not metastatic.
Rectal
Patients who have a diagnosis of large bowel cancer (in the Rectum) and the cancer is not metastatic.



Primary Outcome Measures :
  1. The Incidence of detectable circulating cell tumour derived DNA (ctDNA) in patients with stage II and III colorectal cancer (CRC) pre-operatively [ Time Frame: 3 years ]
    Measure if (ctDNA) is detectable in patients with stage II and III colorectal cancer (CRC) pre-operatively

  2. The correlation between detectable ctDNA at the first post-operative visit & disease free survival [ Time Frame: 5 years ]
    Measure the association between detectable ctDNA at the first post-operative visit & disease free survival


Secondary Outcome Measures :
  1. Relationship between ctDNA detection before, during and after treatment [ Time Frame: 8 years ]
    To calculate the association between detectable ctDNA with disease free survival and overall survival at four time points during treatment.


Biospecimen Retention:   Samples With DNA
FFPE tumour tissue will be retrieved from surgery of patients with stage I, II and III CRC and targeted resequencing by a clinically validated method for a panel of pre-specified genes such as KRAS, NRAS, BRAF, PIK3CA, TP53 and APC will be performed. The study will also collect plasma from these patients and extract cfDNA. ddPCR assays will be used to detect and track tumour specific mutations in cfDNA.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

All patients will have eligibility assessed in a 2 step process, prior to surgery and again post-operatively with the histopathology report from surgery using the criteria below. All patients meeting the eligibility criteria at the first assessment will be registered.

Rectal cancer patients that undergo pre-operative radiotherapy or chemo-radiotherapy will have an additional eligibility assessment after completion of this with the results of their response assessment imaging, after their management plan has been determined. This is most likely to be following multi-disciplinary team discussion.

Criteria

Inclusion Criteria:

  • New diagnosis of histologically confirmed CRC scheduled to undergo surgery with curative intent, with no radiological evidence of metastatic disease.
  • Patients with high grade dysplasia whose imaging is suggestive of colorectal carcinoma (CRC) will be included but will be excluded post-surgery if carcinoma diagnosis is not confirmed
  • Age≥18
  • Ability to give informed consent
  • Able to adhere to follow up schedule

Exclusion Criteria:

  • Scheduled to have neoadjuvant chemotherapy, (neoadjuvant chemoradiotherapy for patients with rectal cancer is permitted)
  • Current or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix or other non-invasive malignancy

Additional eligibility criteria for rectal cancer patients following completion of pre-operative radiotherapy or chemoradiotherapy

Inclusion Criteria:

• All patients proceeding to surgery

Exclusion Criteria:

  • Patients scheduled to have further pre-operative treatment with chemotherapy
  • Patients that are no longer proceeding with surgery i.e. those in whom surgery is considered too high risk
  • Patients that are no longer proceeding with surgery as they are proceeding with a deferral of surgery approach

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): NCT04050345


Contacts
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Contact: Annette Bryant 02086426011 ext 4449 annette.bryant@rmh.nhs.uk
Contact: Shelize Khakoo Shelize.Khakoo@rmh.nhs.uk

Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Annette Bryant    02086426011 ext 4449    annette.bryant@rmh.nhs.uk   
Contact: Sijy Pillai    02086426011 ext 3279    sijy.pillai@rmh.nhs.uk   
Sub-Investigator: Shelize Khakoo         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Study Chair: David Cunningham Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04050345    
Other Study ID Numbers: CCR4344
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases