Actively Recruiting
Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer
Led by Royal Marsden NHS Foundation Trust · Updated on 2024-06-14
1000
Participants Needed
71
Research Sites
764 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New diagnosis of histologically confirmed colorectal cancer scheduled for curative surgery with no metastatic disease
- Patients with high grade dysplasia suggestive of colorectal carcinoma (included initially)
- Age 18 years or older
- Ability to give informed consent
- Ability to follow the study schedule
- Histologically proven high risk stage II or stage III colon or rectal cancer treated with curative surgery alone, or locally advanced stage III rectal cancer treated with neoadjuvant chemoradiotherapy
- Fully surgically resected tumor with clear margins (>1 mm)
- Adequate organ function including neutrophils ≥1.0 x 10^9/L, platelets ≥75 x 10^9/L, hemoglobin ≥80 g/L, adequate renal function, and liver enzymes ≤2.5 times upper normal limit
- No major post-operative complications or conditions contraindicating chemotherapy
- Assessed by oncology team as suitable for adjuvant chemotherapy and able to have post-operative ctDNA sample collected and randomized within 8 ± 2 weeks after surgery
- ECOG performance status 0-2
You will not qualify if you...
- Scheduled for neoadjuvant chemotherapy (except chemoradiotherapy for rectal cancer)
- Current or previous other malignancy within 5 years except certain non-invasive or cured skin and bladder cancers
- History of hypersensitivity or contraindication to planned chemotherapy drugs (CAPOX or capecitabine)
- Planned to receive 5-Fluorouracil based chemotherapy (single or combination) in Part C
- Any major post-operative complications or clinical conditions contraindicating chemotherapy
- Not planned to receive adjuvant chemotherapy in Part C
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 71 locations
1
Milton Keynes General Hospital
Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
Actively Recruiting
2
Croydon University Hospital
Thornton Heath, Croydon, United Kingdom, CR7 7YE
Actively Recruiting
3
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, United Kingdom, DT1 2JY
Actively Recruiting
4
Poole Hospital
Poole, Dorset, United Kingdom, BH15 2JB
Actively Recruiting
5
Broomfield Hospital
Chelmsford, Essex, United Kingdom, CM1 7ET
Actively Recruiting
6
Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M20 4BX
Actively Recruiting
7
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Actively Recruiting
8
University Hospital of South Manchester & Manchester Royal Infirmary
Wythenshawe, Manchester, United Kingdom, M23 9LT
Actively Recruiting
9
Musgrove Park Hospital
Taunton, Somerset, United Kingdom, TA1 5DA
Actively Recruiting
10
Weston General Hospital
Weston-super-Mare, Somerset, United Kingdom, BS23 4TQ
Actively Recruiting
11
Epsom and St Helier's Hospitals NHS Trust
Carshalton, Surrey, United Kingdom, SM5 1AA
Active, Not Recruiting
12
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
13
Guy's & St Thomas Hospital
London, UK, United Kingdom, SE1 9RT
Actively Recruiting
14
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Actively Recruiting
15
Salisbury District Hospital
Salisbury, Whiltshire, United Kingdom, SP2 8BJ
Actively Recruiting
16
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
17
Bronglais Hospital
Aberystwyth, United Kingdom, SY23 1ER
Actively Recruiting
18
Stoke Mandeville Hospital
Aylesbury, United Kingdom, HP21 8AL
Actively Recruiting
19
Basildon and Thurrock University Hospitals
Basildon, United Kingdom, SS16 5NL
Actively Recruiting
20
Basingstoke and North Hampshire Hospitals
Basingstoke, United Kingdom, RG24 9NA
Actively Recruiting
21
Bedford Hospital
Bedford, United Kingdom, MK42 9DJ
Actively Recruiting
22
Royal Blackburn Teaching Hospital
Blackburn, United Kingdom, BB2 3HH
Actively Recruiting
23
Pilgrim Hospital
Boston, United Kingdom, PE21 9QS
Actively Recruiting
24
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Actively Recruiting
25
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
26
Burnley General Teaching Hospital
Burnley, United Kingdom, BB10 2PQ
Actively Recruiting
27
West Suffolk Hospital
Bury, United Kingdom, IP33 2QZ
Actively Recruiting
28
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
29
Kent and Canterbury Hospital
Canterbury, United Kingdom, CT1 3NG
Actively Recruiting
30
North Cumbria University Hospitals
Carlisle, United Kingdom, CA2 7HY
Actively Recruiting
31
Glangwili Hospital
Carmarthen, United Kingdom, SA31 2AF
Actively Recruiting
32
Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
33
University Hospitals Coventry & Warwickshire
Coventry, United Kingdom, CV2 2DX
Actively Recruiting
34
Leighton Hospital
Crewe, United Kingdom, CW26RS
Actively Recruiting
35
University Hospital Crosshouse
Crosshouse, United Kingdom, KA2 0BE
Actively Recruiting
36
Medway NHS Foundation Trust
Gillingham, United Kingdom, ME7 5NY
Active, Not Recruiting
37
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
38
The Princess Alexandra Hospital NHS Trust
Harlow, United Kingdom, CM20 1 QX
Actively Recruiting
39
Withybush General Hospital
Haverfordwest, United Kingdom, SA61 2PZ
Actively Recruiting
40
Wycombe Hospital
High Wycombe, United Kingdom, HP11 2TT
Actively Recruiting
41
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom, HD3 3EA
Actively Recruiting
42
Airedale General Hospital
Keighley, United Kingdom, BD20 6TP
Actively Recruiting
43
Kettering General Hospital
Kettering, United Kingdom, NN16 8UZ
Actively Recruiting
44
Kingston Hospital Foundation Trust
Kingston upon Thames, United Kingdom, KT27QB
Actively Recruiting
45
Forth Valley Royal Hospital
Larbert, United Kingdom, FK5 4WR
Actively Recruiting
46
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
47
Lincoln County Hospital
Lincoln, United Kingdom, LN2 5QY
Actively Recruiting
48
Prince Philip Hospital
Llanelli, United Kingdom, SA14 8QF
Actively Recruiting
49
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Actively Recruiting
50
North Middlesex University Hospital NHS Trust
London, United Kingdom, N18 1QX
Actively Recruiting
51
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
52
St George's NHS Foundation Trust
London, United Kingdom, SW17 0QT
Active, Not Recruiting
53
The Royal Marsden NHS Foundation Trust - London
London, United Kingdom, SW3 6JJ
Actively Recruiting
54
Chelsea and Westminster
London, United Kingdom
Active, Not Recruiting
55
Maidstone & Tunbridge Wells NHS Trust
Maidstone, United Kingdom, ME16 9QQ
Actively Recruiting
56
Chase Farm Hospital
Middlesex, United Kingdom, EN2 8JL
Actively Recruiting
57
Northampton General Hospital NHS Trust
Northampton, United Kingdom, NN1 5BD
Actively Recruiting
58
Nottingham University Hospital
Nottingham, United Kingdom, NG5 1PB
Active, Not Recruiting
59
George Eliot Hospital
Nuneaton, United Kingdom, CV10 7DJ
Actively Recruiting
60
Royal Preston Hospital, Lancashire Teaching Hospitals
Preston, United Kingdom, PR2 9HT
Actively Recruiting
61
Barking Havering and Redbridge NHS Foundation Trust (Queen's Hospital
Romford, United Kingdom, RM7 0AG
Actively Recruiting
62
Weston Park Hospital
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
63
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom, SY3 8XQ
Actively Recruiting
64
South Tyneside District Hospital
South Shields, United Kingdom, NE34 0PL
Actively Recruiting
65
University Hospital Southampton
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
66
Stockport NHS Foundation Trust
Stockport, United Kingdom, SK2 7JE
Actively Recruiting
67
Sunderland Royal Hospital
Sunderland, United Kingdom, SR4 7TP
Actively Recruiting
68
King's Mill Hospital
Sutton in Ashfield, United Kingdom, NG17 4JL
Actively Recruiting
69
Singleton Hospital
Swansea, United Kingdom, SA2 8QA
Actively Recruiting
70
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan, United Kingdom, WN6 9EP
Actively Recruiting
71
Royal Hampshire County Hospital
Winchester, United Kingdom, SO22 5DG
Actively Recruiting
Research Team
H
Hsiang-Chi Chen, MSc
CONTACT
S
Susie Slater, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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