Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer
TRACC
1 other identifier
observational
1,000
1 country
71
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2016
CompletedFirst Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2031
June 14, 2024
June 1, 2024
12.7 years
October 30, 2018
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
TRACC Part B (Translational sub study)
• To assess whether detection of ctDNA predicts for relapse in patients with stage II and III colorectal cancer (CRC) that have undergone surgery with curative intent
6 years
TRACC Part C (Randomised ctDNA guided adjuvant chemotherapy versus SoC study):
• To demonstrate de-escalation strategy of ctDNA guided adjuvant chemotherapy is non- inferior to standard of care treatment as measured by 3 year disease free survival in patients with high risk stage II or stage III colorectal cancer with no evidence of minimal residual disease (ctDNA negative)
4 years
Secondary Outcomes (1)
Relationship between ctDNA detection before, during and after treatment
8 years
Study Arms (4)
Part B TRACC Colon
Patients with diagnosis of large bowel cancer (in the colon) and no evidence of metastatic disease
Part B TRACC Rectal
Patients who have a diagnosis of large bowel cancer (in the Rectum) and no evidence of metastatic disease
Part C TRACC- Standard of Care Adjuvant Chemotherapy
Randomised to Arm A: Standard of Care Arm (Patients with fully resected high risk stage II or stage III colon or Rectal cancer with no evidence of metastatic disease. Patients with locally advanced rectal cancer who have previously undergone chemoradiotherapy are also eligible to enrol.
Part C-ct DNA Guided Arm
Patients with fully resected high risk stage II or stage III colon or rectal cancer with no evidence of metastatic disease. Patients with locally advanced rectal cancer who have previously undergone chemoradiotherapy are also eligible to enrol. De-escalation of adjuvant chemotherapy in patients who have a post-operative ctDNA negative result
Eligibility Criteria
TRACC Part B patients will have eligibility assessed, prior to surgery and again post-operatively with the histopathology report from surgery using the criteria below. Patients meeting the eligibility criteria at the first assessment will be registered. Rectal cancer patients that undergo pre-operative radiotherapy or chemo-radiotherapy have an additional eligibility assessment after treatment with the results of their imaging. TRACC Part C: patients with histologically proven High risk Stage 2 or Stage 3 colon or rectal cancer, treated with curative surgery with no evidence of metastatic disease. Patients with histologically proven rectal cancer who have previously undergone neoadjuvant chemoradiotherapy are also eligible. Patients must be due to receive adjuvant chemotherapy,
You may qualify if:
- 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
You may not qualify if:
- 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
- TRACC Part C
- Subject ≥ 18 years of age
- Subjects with histologically proven high risk stage II or stage III colon or rectal cancer treated with curative intent with surgery alone (any T, N1 or N2) with no evidence of metastatic disease. High risk stage II is defined as having one or more of the following: T4 disease, obstruction and/or perforation of the primary tumour during the pre-operative period, inadequate nodal harvest as indicated by \<12 nodes examined, poorly differentiated grade on histology, perineural invasion, peritoneal involvement or extramural venous/lymphatic invasion. Subjects must be due to receive adjuvant chemotherapy after surgery or Subjects with histologically proven locally advanced stage III rectal cancer treated with neoadjuvant chemoradiotherapy (any T, N1 or N2, M0) with no evidence of metastatic disease are eligible. Subjects must be due to receive adjuvant chemotherapy after surgery
- Fully surgically resected tumour with clear resection margins (i.e., \>1 mm).
- Adequate organ function
- Absolute neutrophil function ≥1.0 x 109/ L
- Platelet Count ≥ 75 x 109 / L
- Haemoglobin ≥80g/L (blood transfusion before randomisation is allowed)
- Adequate renal function (GFR ≥ 50ml/min if single agent capecitabine or CAPOX being administered) as calculated by Cockcroft and Gault equation
- Aspartate aminotransferase/ Alanine aminotransferase levels ≤ 2.5 upper limit of normal
- Absence of major post-operative complications or other clinical conditions that, in the opinion of the investigator, would contraindicate adjuvant chemotherapy
- Patients should be assessed by Oncology team for suitability and assessment for adjuvant chemotherapy, be able to have post-operative ctDNA sample collected and be randomised by week 8 ± 2 weeks after surgery.
- ECOG performance status 0- 2
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Milton Keynes General Hospital
Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom
Croydon University Hospital
Thornton Heath, Croydon, CR7 7YE, United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, DT1 2JY, United Kingdom
Poole Hospital
Poole, Dorset, BH15 2JB, United Kingdom
Broomfield Hospital
Chelmsford, Essex, CM1 7ET, United Kingdom
Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY, United Kingdom
University Hospital of South Manchester & Manchester Royal Infirmary
Wythenshawe, Manchester, M23 9LT, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA, United Kingdom
Weston General Hospital
Weston-super-Mare, Somerset, BS23 4TQ, United Kingdom
Epsom and St Helier's Hospitals NHS Trust
Carshalton, Surrey, SM5 1AA, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
Guy's & St Thomas Hospital
London, UK, SE1 9RT, United Kingdom
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
Salisbury District Hospital
Salisbury, Whiltshire, 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
The 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
Related Publications (2)
Slater S, Bryant A, Aresu M, Begum R, Chen HC, Peckitt C, Lazaro-Alcausi R, Carter P, Anandappa G, Khakoo S, Melcher L, Potter V, Marti FM, Huang J, Branagan G, George N, Abulafi M, Duff S, Raja A, Gupta A, West N, Bucheit L, Rich T, Chau I, Cunningham D, Starling N; TRACC Part B trial investigators. Tissue-Free Liquid Biopsies Combining Genomic and Methylation Signals for Minimal Residual Disease Detection in Patients with Early Colorectal Cancer from the UK TRACC Part B Study. Clin Cancer Res. 2024 Aug 15;30(16):3459-3469. doi: 10.1158/1078-0432.CCR-24-0226.
PMID: 38864835DERIVEDSlater S, Bryant A, Chen HC, Begum R, Rana I, Aresu M, Peckitt C, Zhitkov O, Lazaro-Alcausi R, Borja V, Powell R, Lowery D, Hubank M, Rich T, Anandappa G, Chau I, Starling N, Cunningham D. ctDNA guided adjuvant chemotherapy versus standard of care adjuvant chemotherapy after curative surgery in patients with high risk stage II or stage III colorectal cancer: a multi-centre, prospective, randomised control trial (TRACC Part C). BMC Cancer. 2023 Mar 20;23(1):257. doi: 10.1186/s12885-023-10699-4.
PMID: 36941575DERIVED
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Cunningham
Royal Marsden NHS Foundation Trust
Central Study Contacts
Susie Slater, Dr
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2018
First Posted
August 8, 2019
Study Start
December 5, 2016
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2031
Last Updated
June 14, 2024
Record last verified: 2024-06