RecruitingNCT04050345

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


Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

1,000 participants

Start Date

Dec 5, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called TRACC) examines whether a blood test that detects tiny fragments of cancer DNA floating in the bloodstream (called circulating tumor DNA or ctDNA) can predict which colorectal cancer patients are likely to relapse after surgery — potentially allowing doctors to treat high-risk patients earlier. **You may be eligible if...** - You have been newly diagnosed with colorectal cancer (CRC) confirmed by biopsy - You are scheduled for surgery with the goal of cure (no signs of distant spread) - You are 18 or older and able to attend follow-up visits - (For Part C): You have high-risk Stage II or Stage III colon or rectal cancer treated with surgery **You may NOT be eligible if...** - You are scheduled to receive chemotherapy before surgery (except rectal cancer patients receiving chemoradiotherapy) - You have had another cancer in the past 5 years (some skin and localized cancers excepted) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(71)

Milton Keynes General Hospital

Milton Keynes, Buckinghamshire, United Kingdom

Croydon University Hospital

Thornton Heath, Croydon, United Kingdom

Dorset County Hospital NHS Foundation Trust

Dorchester, Dorset, United Kingdom

Poole Hospital

Poole, Dorset, United Kingdom

Broomfield Hospital

Chelmsford, Essex, United Kingdom

Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

University Hospital of South Manchester & Manchester Royal Infirmary

Wythenshawe, Manchester, United Kingdom

Musgrove Park Hospital

Taunton, Somerset, United Kingdom

Weston General Hospital

Weston-super-Mare, Somerset, United Kingdom

Epsom and St Helier's Hospitals NHS Trust

Carshalton, Surrey, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Guy's & St Thomas Hospital

London, UK, United Kingdom

Bradford Royal Infirmary

Bradford, West Yorkshire, United Kingdom

Salisbury District Hospital

Salisbury, Whiltshire, United Kingdom

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Bronglais Hospital

Aberystwyth, United Kingdom

Stoke Mandeville Hospital

Aylesbury, United Kingdom

Basildon and Thurrock University Hospitals

Basildon, United Kingdom

Basingstoke and North Hampshire Hospitals

Basingstoke, United Kingdom

Bedford Hospital

Bedford, United Kingdom

Royal Blackburn Teaching Hospital

Blackburn, United Kingdom

Pilgrim Hospital

Boston, United Kingdom

Royal Bournemouth Hospital

Bournemouth, United Kingdom

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

Burnley General Teaching Hospital

Burnley, United Kingdom

West Suffolk Hospital

Bury, United Kingdom

Addenbrookes Hospital

Cambridge, United Kingdom

Kent and Canterbury Hospital

Canterbury, United Kingdom

North Cumbria University Hospitals

Carlisle, United Kingdom

Glangwili Hospital

Carmarthen, United Kingdom

Castle Hill Hospital

Cottingham, United Kingdom

University Hospitals Coventry & Warwickshire

Coventry, United Kingdom

Leighton Hospital

Crewe, United Kingdom

University Hospital Crosshouse

Crosshouse, United Kingdom

Medway NHS Foundation Trust

Gillingham, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

The Princess Alexandra Hospital NHS Trust

Harlow, United Kingdom

Withybush General Hospital

Haverfordwest, United Kingdom

Wycombe Hospital

High Wycombe, United Kingdom

Calderdale and Huddersfield NHS Foundation Trust

Huddersfield, United Kingdom

Airedale General Hospital

Keighley, United Kingdom

Kettering General Hospital

Kettering, United Kingdom

Kingston Hospital Foundation Trust

Kingston upon Thames, United Kingdom

Forth Valley Royal Hospital

Larbert, United Kingdom

St James's University Hospital

Leeds, United Kingdom

Lincoln County Hospital

Lincoln, United Kingdom

Prince Philip Hospital

Llanelli, United Kingdom

Barts Health NHS Trust

London, United Kingdom

North Middlesex University Hospital NHS Trust

London, United Kingdom

Royal Free Hospital

London, United Kingdom

St George's NHS Foundation Trust

London, United Kingdom

The Royal Marsden NHS Foundation Trust - London

London, United Kingdom

Chelsea and Westminster

London, United Kingdom

Maidstone & Tunbridge Wells NHS Trust

Maidstone, United Kingdom

Chase Farm Hospital

Middlesex, United Kingdom

Northampton General Hospital NHS Trust

Northampton, United Kingdom

Nottingham University Hospital

Nottingham, United Kingdom

George Eliot Hospital

Nuneaton, United Kingdom

Royal Preston Hospital, Lancashire Teaching Hospitals

Preston, United Kingdom

Barking Havering and Redbridge NHS Foundation Trust (Queen's Hospital

Romford, United Kingdom

Weston Park Hospital

Sheffield, United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, United Kingdom

South Tyneside District Hospital

South Shields, United Kingdom

University Hospital Southampton

Southampton, United Kingdom

Stockport NHS Foundation Trust

Stockport, United Kingdom

Sunderland Royal Hospital

Sunderland, United Kingdom

King's Mill Hospital

Sutton in Ashfield, United Kingdom

Singleton Hospital

Swansea, United Kingdom

Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan, United Kingdom

Royal Hampshire County Hospital

Winchester, United Kingdom

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