At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 175 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at bowel cancer (colorectal cancer). It tests whether tracking tiny pieces of tumour DNA in the blood (called circulating tumour DNA, or ctDNA) can help predict whether early-stage bowel cancer might come back after surgery.
Who can take part
- Adults aged 18 or over
- People with a new diagnosis of bowel cancer confirmed by tissue tests, who are due to have surgery aiming to cure the cancer, with no sign the cancer has spread (for Part B)
- For Part C: people with higher-risk stage II or stage III bowel cancer treated with surgery, due to have chemotherapy after surgery, with no sign of spread
- For Part C: blood tests showing good enough organ function, and ability to give consent and follow the study schedule
Who may not be able to
- People scheduled to have chemotherapy before surgery (though chemoradiotherapy before surgery is allowed for rectal cancer, for Part B)
- People who have had another cancer in the last 5 years, apart from certain cured or non-invasive cancers
- For Part C: people not due to have chemotherapy after surgery
- For Part C: people having 5-Fluorouracil-based chemotherapy, or who are allergic to the planned chemotherapy drugs
- For Part C: people with serious problems after surgery or other conditions that make chemotherapy unsafe
What taking part involves
- • Blood samples to look for circulating tumour DNA (ctDNA)
- • Surgery to remove the cancer as planned by your doctors
- • For Part C: chemotherapy after surgery (either capecitabine on its own, or CAPOX)
Time commitment: For Part C: randomisation by 8 weeks (plus or minus 2 weeks) after surgery, with blood samples taken after surgery; full visit schedule and study length: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,000
- Started
- 2016-12-05
- Last checked
- 2024-06
Plain English Summary
What is this study?
- • Testing a new treatment for colorectal cancer
- • Clinical study - 1,000 participants
- • TRACC Part B 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with colorectal cancer
Where?
- • Milton Keynes - Milton Keynes General Hospital
- • Thornton Heath - Croydon University Hospital
- • Dorchester - Dorset County Hospital NHS Foundation Trust
- • Poole - Poole Hospital
- • +67 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
TRACC Part B 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. TRACC Part C is a : (multi-centre, prospective, randomised study, of ctDNA guided adjuvant chemotherapy versus standard of care adjuvant chemotherapy study after curative surgery in patients with high risk stage II or stage III CRC. )It aims to demonstrate that a de-escalation strategy of ctDNA guided adjuvant chemotherapy is non- inferior to standard of care treatment as measured by 3 year disease free survival (DFS) in patients with high risk stage II or stage III colorectal cancer CRC with no evidence of minimal residual disease (MRD) (ctDNA negative)
More detail
TRACC Part B: Despite potentially curative surgery +/- adjuvant chemotherapy, a proportional of patients with early stage CRC will experience disease relapse. Current tools for surveillance, e.g., blood sampling for tumour markers (CEA) are neither sensitive nor specific. We hypothesise that detection of mutations in circulating free DNA (cfDNA) in plasma can predict relapse in patients with early stage CRC. Circulating cell free tumour DNA (ctDNA) maintains the same mutations that are present in tumour. In colorectal cancer CRC, primary tumours and\& metastases exhibit high genomic concordance. Therefore the TRACC study TRACC Part B is investigating whether serial blood samples taken from in patients with stage II and III fully resected early stage CRC colorectal cancer that have undergone potentially curative surgery, blood samples to can be used to detect and\& quantify ctDNA may in order to identify minimal residual disease MRD and predict 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. TRACC Part C: We hypothesis that ctDNA guided adjuvant chemotherapy administration will enable biomarker driven selection of patients who would and would not benefit from adjuvant chemotherapy and thereby reduce the proportion of patient receiving unnecessary adjuvant chemotherapy, reducing the potential side effects associated with it, but without compromising disease free survival (DFS). : This part of the study will use tThe blood test ctDNA result from a post-operative blood sample willto guide adjuvant chemotherapy treatment decisions. The study aims to demonstrate that athe de -escalation strategy of ctDNA guided adjuvant chemotherapy is non-inferior to standard of care treatment as measured by 3 year DFS in patients with high risk stage II and stage III CRC, in those who have no evidence of MRD (ctDNA negative). after surgery for patients with colorectal cancer who are following the standard of care pathway. Patients are randomised at the post- operative time point to: Arm A (standard of care adjuvant chemotherapy), or Arm B (ctDNA guided adjuvant chemotherapy) arm. For the ct DNA guided arm, patients who are ctDNA negative at this time point will have their chemotherapy de-escalated.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
What the study is looking for
- ✓New diagnosis of confirmed by a biopsy CRC scheduled to undergo surgery with curative intent, with no...
- ✓Patients with high grade dysplasia whose imaging is suggestive of colorectal carcinoma (CRC) will be included but...
- ✓Age≥18
- ✓Ability to give agreement to take part
- ✓Able to adhere to follow up schedule
Who cannot take part
- ✗Scheduled to have before surgery drug treatment, (before surgery chemoradiotherapy for patients with rectal cancer is permitted)
- ✗TRACC Part C
- ✗Inclusion Criteria:
- ✗Subject ≥ 18 years of age
- ✗Fully surgically resected tumour with clear resection margins (i.e., \>1 mm).
See the full criteria
Where Is This Study? (71 UK sites)
Milton Keynes General Hospital
Milton Keynes MK6 5LD, United Kingdom
Croydon University Hospital
Thornton Heath CR7 7YE, United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester DT1 2JY, United Kingdom
Poole Hospital
Poole BH15 2JB, United Kingdom
Broomfield Hospital
Chelmsford CM1 7ET, United Kingdom
Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Queen Alexandra Hospital
Portsmouth PO6 3LY, United Kingdom
University Hospital of South Manchester & Manchester Royal Infirmary
Wythenshawe M23 9LT, United Kingdom
Musgrove Park Hospital
Taunton TA1 5DA, United Kingdom
Weston General Hospital
Weston-super-Mare BS23 4TQ, United Kingdom
Epsom and St Helier's Hospitals NHS Trust
Carshalton SM5 1AA, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton SM2 5PT, United Kingdom
Guy's & St Thomas Hospital
London SE1 9RT, United Kingdom
Bradford Royal Infirmary
Bradford BD9 6RJ, United Kingdom
Salisbury District Hospital
Salisbury SP2 8BJ, United Kingdom
Aberdeen Royal Infirmary
Aberdeen AB25 2ZN, United Kingdom
Bronglais Hospital
Aberystwyth SY23 1ER, United Kingdom
Stoke Mandeville Hospital
Aylesbury HP21 8AL, United Kingdom
Basildon and Thurrock University Hospitals
Basildon SS16 5NL, United Kingdom
Basingstoke and North Hampshire Hospitals
Basingstoke RG24 9NA, United Kingdom
Bedford Hospital
Bedford MK42 9DJ, United Kingdom
Royal Blackburn Teaching Hospital
Blackburn BB2 3HH, United Kingdom
Pilgrim Hospital
Boston PE21 9QS, United Kingdom
Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol BS2 8ED, United Kingdom
Burnley General Teaching Hospital
Burnley BB10 2PQ, United Kingdom
West Suffolk Hospital
Bury IP33 2QZ, United Kingdom
Addenbrookes Hospital
Cambridge CB2 0QQ, United Kingdom
Kent and Canterbury Hospital
Canterbury CT1 3NG, United Kingdom
North Cumbria University Hospitals
Carlisle CA2 7HY, United Kingdom
Glangwili Hospital
Carmarthen SA31 2AF, United Kingdom
Castle Hill Hospital
Cottingham HU16 5JQ, United Kingdom
University Hospitals Coventry & Warwickshire
Coventry CV2 2DX, United Kingdom
Leighton Hospital
Crewe CW26RS, United Kingdom
University Hospital Crosshouse
Crosshouse KA2 0BE, United Kingdom
Medway NHS Foundation Trust
Gillingham ME7 5NY, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
The Princess Alexandra Hospital NHS Trust
Harlow CM20 1 QX, United Kingdom
Withybush General Hospital
Haverfordwest SA61 2PZ, United Kingdom
Wycombe Hospital
High Wycombe HP11 2TT, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield HD3 3EA, United Kingdom
Airedale General Hospital
Keighley BD20 6TP, United Kingdom
Kettering General Hospital
Kettering NN16 8UZ, United Kingdom
Kingston Hospital Foundation Trust
Kingston upon Thames KT27QB, United Kingdom
Forth Valley Royal Hospital
Larbert FK5 4WR, United Kingdom
St James's University Hospital
Leeds LS9 7TF, United Kingdom
Lincoln County Hospital
Lincoln LN2 5QY, United Kingdom
Prince Philip Hospital
Llanelli SA14 8QF, United Kingdom
Barts Health NHS Trust
London EC1A 7BE, United Kingdom
North Middlesex University Hospital NHS Trust
London N18 1QX, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
St George's NHS Foundation Trust
London SW17 0QT, United Kingdom
Tania West, R&D Governance & Clinical Trials Manager
tania.west@swlstg.nhs.uk020 3513 6420The Royal Marsden NHS Foundation Trust - London
London SW3 6JJ, United Kingdom
Chelsea and Westminster
London, United Kingdom
Maidstone & Tunbridge Wells NHS Trust
Maidstone ME16 9QQ, United Kingdom
Chase Farm Hospital
Middlesex EN2 8JL, United Kingdom
Northampton General Hospital NHS Trust
Northampton NN1 5BD, United Kingdom
Nottingham University Hospital
Nottingham NG5 1PB, United Kingdom
George Eliot Hospital
Nuneaton CV10 7DJ, United Kingdom
Royal Preston Hospital, Lancashire Teaching Hospitals
Preston PR2 9HT, United Kingdom
Barking Havering and Redbridge NHS Foundation Trust (Queen's Hospital
Romford RM7 0AG, United Kingdom
Weston Park Hospital
Sheffield S10 2JF, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury SY3 8XQ, United Kingdom
South Tyneside District Hospital
South Shields NE34 0PL, United Kingdom
University Hospital Southampton
Southampton SO16 6YD, United Kingdom
Stockport NHS Foundation Trust
Stockport SK2 7JE, United Kingdom
Sunderland Royal Hospital
Sunderland SR4 7TP, United Kingdom
King's Mill Hospital
Sutton in Ashfield NG17 4JL, United Kingdom
Singleton Hospital
Swansea SA2 8QA, United Kingdom
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan WN6 9EP, United Kingdom
Royal Hampshire County Hospital
Winchester SO22 5DG, United Kingdom
How to Get in Touch
Hsiang-Chi Chen, MSc
Sponsor contactCONTACT
Susie Slater, Dr
Sponsor contactCONTACT