An EU-funded project involving multiple scientific and industry partners in EU and US.
The project aims to identify the most accurate and sensitive ctDNA test available for detecting minimal residual disease (MRD) and for guiding treatment choices.
In the initial part of the project novel ctDNA standards will be defined that will be used for benchmarking currently available blood tests.
In the second phase of project, the most promising ctDNA blood tests will be compared head-to-head in prospective randomized lung, pancreatic and colorectal cancers trials.

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RESPONSE: coloRectal cancEr Survivors’ follow-uP care – nOw digi-tal and Need-baSEd. A national interventional trial for stage I and II patients.

A national multicenter prospective interventional study comparing ctDNA and ePROM guided surveillance to standard of care CT-imaging based surveillance.

Population: Stage I and low-risk stage II colorectal cancer patients

Sample size: 400

Description:

The study Intervention Group (IG) receives ctDNA and ePROM guided surveillance, which includes: 1) serial ctDNA monitoring to identify individuals with high risk of recurrence, 2) serial ePROM monitoring to identify ‘organ-specific late effects’ and ‘biopsychosocial late effects’, 3) planned and systematic management/intervention of recurrence and late effects, and 4) personalized self-managed follow-up by a digital care guide as a smartphone application.

The standard-of-care group (SG) receives standard-of-care CT-imaging based recurrence surveillance.

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A prospective observational study exploring the prognostic and predictive value of measuring ctDNA prior to and after curative intended treatment, andduring postoperative surveillance.

Population: Stage I-III colorectal cancer patients

Sample size: 1600

Clinicaltrials.gov: NCT06076811

A randomized controlled trial investigating the benefit of ctDNA guided postoperative surveillance compared to the current standard-of-care CT-scan surveillance for patients with colorectal cancer.

Population:      Adjuvant chemotherapy treated stage II high risk and stage III colorectal cancer patients
Sample size:    310
Clinicaltrials.gov: NCT04084249

A prospective observational study exploring the prognostic and predictive value of measuring ctDNA prior to and after curative intended treatment, and during postoperative surveillance.

Population:   Stage I-III colorectal cancer patients
Sample size:  2500
Clinicaltrials.gov: NCT03748680

A randomized controlled trial investigating the benefit of plasma ctDNA guided postoperative surveillance of patients resected (R0/R1) for stage I, II and III PDAC compared to the current standard-of-care surveillance

Population:      Patients resected with curative intend for stage I, II and III pancreatic cancer
Sample size:    410

A prospective randomized trial investigating the effect of RFA-mediated immune-stimulation in patients undergoing curative-intent surgery for CRLM, compared to current standard-of-care. The study also explores the utility of using ctDNA as a biomarker for prediction of incipient recurrence.

Population:      Patients treated with curative intend for colorectal liver metastases
Sample size:    220
Clinicaltrials.gov: NCT04798898

A randomized trial investigating if treating postoperative ctDNA positive patients standard adjuvant chemotherapy therapy improves the disease free survival, compared to the standard of care surveillance.

Population:   Stage I-II ctDNA positive colorectal cancer patients
Sample size:  36
ClinicalTrials.gov: NCT03748680

The DCCC ctDNA Research Center is a national founded research center for ctDNA guided cancer treatment. We develop clinical protocols and provide critical infrastructure for conducting ctDNA guided treatments trials. The objective of the center is to provide a framework for faster clinical implementation of ctDNA guided treatment decisions.
The center is managed by Center Director Professor Claus Lindbjerg Andersen and Center Vice Director Professor Lars Dyrskjøt Andersen.