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Tracking mutations in blood to predict relapse in early colorectal cancer

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

Observational Royal Marsden NHS Foundation Trust · NCT04050345

This study is testing if tracking certain DNA changes in the blood can help predict if people with early colorectal cancer will have a relapse after surgery.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorRoyal Marsden NHS Foundation Trust Academic / other
Drugs / interventionschemotherapy
Locations71 sites (Milton Keynes, Buckinghamshire and 70 other locations)
Trial IDNCT04050345 on ClinicalTrials.gov

What this trial studies

This observational study involves collecting and analyzing tumor tissue, blood samples, and clinical data from patients newly diagnosed with stage I, II, and III colorectal cancer (CRC). The aim is to determine if mutations in circulating free DNA (cfDNA) can predict relapse in patients who have undergone potentially curative surgery. By identifying minimal residual disease (MRD) through serial blood samples, the study seeks to improve early detection of relapse compared to current methods. Additionally, it explores whether ctDNA-guided adjuvant chemotherapy can reduce unnecessary treatment in patients unlikely to benefit from it.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, histologically confirmed stage I, II, or III colorectal cancer scheduled for curative surgery.

Not a fit: Patients with current or previous malignancies within the last five years, except for certain non-invasive cancers, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized treatment plans and potentially spare patients from unnecessary chemotherapy and its side effects.

How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer relapse, indicating that this approach is gaining traction in the field.

Eligibility criteria

Show full inclusion / exclusion criteria 
TRACC Part B Inclusion Criteria:

* 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

TRACC Part B Exclusion Criteria:

* 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

Inclusion Criteria:

1. Subject ≥ 18 years of age
2. 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
3. Fully surgically resected tumour with clear resection margins (i.e., \>1 mm).
4. 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
5. Absence of major post-operative complications or other clinical conditions that, in the opinion of the investigator, would contraindicate adjuvant chemotherapy
6. 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.
7. ECOG performance status 0- 2
8. 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

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Where this trial is running

Milton Keynes, Buckinghamshire and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.