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Colorectal CancerTRACCNCT04050345

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

An observational study of Colorectal Cancer, run by Royal Marsden NHS Foundation Trust at 71 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
How many people
1,000 participants
Where
71 sitesUnited Kingdom
Study dates
5 Dec 2016to 31 Jul 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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,

Who may be able to join

  • 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
Show all 16Show fewer
  • 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
  • Able to give informed consent
  • TRACC Part C Exclusion criteria
  • 1. History of concurrent and previous malignancy within the last 5 years, with the exception of non- melanomatous skin cancer and carcinoma in situ 2. Any major post-operative complications or other clinical conditions that in the opinion of the investigator would contra-indicate adjuvant chemotherapy 3. Any subject not due to receive adjuvant chemotherapy will not be eligible for Part C of the study 4. Hypersensitivity or contraindication to the drug(s) associated with the planned choice of systemic chemotherapy (CAPOX or single agent capecitabine) as stated in the SmPC for each of the drugs 5. Subjects due to receive 5-Flurouracil (5-FU) based adjuvant chemotherapy (either single agent 5-FU or in combination with oxaliplatin) will not be eligible for Part C of the study
  • -

Who cannot join

None listed.

Trial locations and contacts

71 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hsiang-Chi Chen, MSc contact

02086426011

TRACCStudy@rmh.nhs.uk

Susie Slater, Dr contact

71 sites in 1 country

United Kingdom71 sites, 66 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

    Adnan Shaukat

    Recruiting

  • Bronglais Hospital

    Aberystwyth, SY23 1ER

    Elin Jones

    Recruiting

  • Stoke Mandeville Hospital

    Aylesbury, HP21 8AL

    XingWu Zhu

    Recruiting

  • Basildon and Thurrock University Hospitals

    Basildon, SS16 5NL

    Nadeem Ashraf

    Recruiting

  • Basingstoke and North Hampshire Hospitals

    Basingstoke, RG24 9NA

    Francesco DiFabio

    Recruiting

  • Bedford Hospital

    Bedford, MK42 9DJ

    Yuksel Gercek

    Recruiting

  • Royal Blackburn Teaching Hospital

    Blackburn, BB2 3HH

    Prasad Kellati

    Recruiting

  • Pilgrim Hospital

    Boston, PE21 9QS

    Zuzana Stokes

    Recruiting

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

    Bryony Eccles

    Recruiting

  • Bradford Royal Infirmary

    Bradford, West Yorkshire, BD9 6RJ

    Sohail Mughal

    Recruiting

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS2 8ED

    Stephen Falks

    Recruiting

  • Burnley General Teaching Hospital

    Burnley, BB10 2PQ

    Prasad Kellati

    Recruiting

  • West Suffolk Hospital

    Bury, IP33 2QZ

    Daniel Patterson

    Recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

    Ultan McDermott

    Recruiting

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

    Rakesh Raman

    Recruiting

  • North Cumbria University Hospitals

    Carlisle, CA2 7HY

    Sorena Afshar

    Recruiting

  • Glangwili Hospital

    Carmarthen, SA31 2AF

    Craig Barrington

    Recruiting

  • Epsom and St Helier's Hospitals NHS Trust

    Carshalton, Surrey, SM5 1AA

    Active, not recruiting

  • Broomfield Hospital

    Chelmsford, Essex, CM1 7ET

    Nicole George

    Recruiting

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

    Rajarshi Roy

    Recruiting

  • University Hospitals Coventry & Warwickshire

    Coventry, CV2 2DX

    Venessa Potter

    Recruiting

  • Leighton Hospital

    Crewe, CW26RS

    Michael Braun

    Recruiting

  • University Hospital Crosshouse

    Crosshouse, KA2 0BE

    Lisa Rodgers

    Recruiting

  • Dorset County Hospital NHS Foundation Trust

    Dorchester, Dorset, DT1 2JY

    Amelie Harle

    Recruiting

  • Medway NHS Foundation Trust

    Gillingham, ME7 5NY

    Active, not recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    Janet Graham

    Recruiting

  • The Princess Alexandra Hospital NHS Trust

    Harlow, CM20 1 QX

    Venkatesh Gajapathy

    Venkatesh Gajapathy

    Recruiting

  • Withybush General Hospital

    Haverfordwest, SA61 2PZ

    Craig Barrington

    Recruiting

  • Wycombe Hospital

    High Wycombe, HP11 2TT

    XingWu Zhu

    Recruiting

  • Calderdale and Huddersfield NHS Foundation Trust

    Huddersfield, HD3 3EA

    Sam Turnbull

    Recruiting

  • Airedale General Hospital

    Keighley, BD20 6TP

    Shazza Rehman

    Recruiting

  • Kettering General Hospital

    Kettering, NN16 8UZ

    Roshan Agarwal

    Recruiting

  • Kingston Hospital Foundation Trust

    Kingston upon Thames, KT27QB

    Sheela Rao

    Recruiting

  • Forth Valley Royal Hospital

    Larbert, FK5 4WR

    Lisa Rodgers

    Recruiting

  • St James's University Hospital

    Leeds, LS9 7TF

    Alexandra Gilbert

    Recruiting

  • Lincoln County Hospital

    Lincoln, LN2 5QY

    Zuzana Stokes

    Recruiting

  • Prince Philip Hospital

    Llanelli, SA14 8QF

    Craig Barrington

    Recruiting

  • Guy's & St Thomas Hospital

    London, UK, SE1 9RT

    Paul Ross

    Recruiting

  • Barts Health NHS Trust

    London, EC1A 7BE

    Marco Gerlinger

    Recruiting

  • North Middlesex University Hospital NHS Trust

    London, N18 1QX

    Lucinder Melcher

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Nikolaos Diamantis

    Recruiting

  • St George's NHS Foundation Trust

    London, SW17 0QT

    Active, not recruiting

  • The Royal Marsden NHS Foundation Trust - London

    London, SW3 6JJ

    David Cunningham

    Recruiting

  • Chelsea and Westminster

    London

    Active, not recruiting

  • Maidstone & Tunbridge Wells NHS Trust

    Maidstone, ME16 9QQ

    Mark Hill

    Recruiting

  • Christie NHS Foundation Trust

    Manchester, Greater Manchester, M20 4BX

    Kalena Marti

    Recruiting

  • Chase Farm Hospital

    Middlesex, EN2 8JL

    Nikolaos Diamantis

    Recruiting

  • Milton Keynes General Hospital

    Milton Keynes, Buckinghamshire, MK6 5LD

    Wasiry Saka

    Recruiting

  • Northampton General Hospital NHS Trust

    Northampton, NN1 5BD

    Roshan Agarwal

    Recruiting

  • Nottingham University Hospital

    Nottingham, NG5 1PB

    Active, not recruiting

  • George Eliot Hospital

    Nuneaton, CV10 7DJ

    Martin Scott-Brown

    Recruiting

  • Poole Hospital

    Poole, Dorset, BH15 2JB

    Bryony Eccles

    Recruiting

  • Queen Alexandra Hospital

    Portsmouth, Hampshire, PO6 3LY

    Ann O'Callaghan

    Recruiting

  • Royal Preston Hospital, Lancashire Teaching Hospitals

    Preston, PR2 9HT

    Deborah Willliamson

    Recruiting

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

    Romford, RM7 0AG

    Joseph Huang

    Recruiting

  • Salisbury District Hospital

    Salisbury, Whiltshire, SP2 8BJ

    Graham Branagan

    Graham Branagan

    Recruiting

  • Weston Park Hospital

    Sheffield, S10 2JF

    Alice Dewdney

    Recruiting

  • Royal Shrewsbury Hospital

    Shrewsbury, SY3 8XQ

    Yash Choudhary

    Recruiting

  • South Tyneside District Hospital

    South Shields, NE34 0PL

    Ashraf Azzabi

    Recruiting

  • University Hospital Southampton

    Southampton, SO16 6YD

    Charlotte Rees

    Recruiting

  • Stockport NHS Foundation Trust

    Stockport, SK2 7JE

    Clare Hall

    Recruiting

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP

    Ashraf AZZABI

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

    David Cunningham

    Recruiting

  • King's Mill Hospital

    Sutton in Ashfield, NG17 4JL

    Syed Karim

    Recruiting

  • Singleton Hospital

    Swansea, SA2 8QA

    Sing Yu Moorcraft

    Recruiting

  • Musgrove Park Hospital

    Taunton, Somerset, TA1 5DA

    Emma Gray

    Recruiting

  • Croydon University Hospital

    Thornton Heath, Croydon, CR7 7YE

    Muti Abulafi

    Recruiting

  • Weston General Hospital

    Weston-super-Mare, Somerset, BS23 4TQ

    Thomas Strawson-Smith

    Recruiting

  • Wrightington, Wigan and Leigh NHS Foundation Trust

    Wigan, WN6 9EP

    Kalena Marti

    Recruiting

  • Royal Hampshire County Hospital

    Winchester, SO22 5DG

    Jack Broadhurst

    Recruiting

  • University Hospital of South Manchester & Manchester Royal Infirmary

    Wythenshawe, Manchester, M23 9LT

    Sarah Duff

    Sarah Duff

    Recruiting

Other trials in United Kingdom

About this study

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)

Read the detailed description

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.

Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04050345
Study groupRoleWhat they receive
Part B TRACC ColonPatients with diagnosis of large bowel cancer (in the colon) and no evidence of metastatic disease
Part B TRACC RectalPatients who have a diagnosis of large bowel cancer (in the Rectum) and no evidence of metastatic disease
Part C TRACC- Standard of Care Adjuvant ChemotherapyRandomised 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 ArmPatients 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 years

  2. 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)

    Measured: 4 years

Secondary outcomes (1)

  1. Relationship between ctDNA detection before, during and after treatment

    To calculate the association between detectable ctDNA with disease free survival and overall survival at four time points during treatment.

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start5 Dec 2016
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050345
Sponsor's protocol ID
CCR4344
Acronym
TRACC
Status last verified
Jun 2024
First submitted
30 Oct 2018
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38864835

  • Slater 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.

    PubMed 36941575

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Royal Marsden NHS Foundation Trust at 71 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hsiang-Chi Chen, MSc (02086426011, TRACCStudy@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TRACC Part B (Translational sub study) (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04050345, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

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