An observational study in Liver Metastases, Colorectal Cancer and Breast Cancer, sponsored by Cancer Research Antwerp. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Cancer Research Antwerp · Observational
This is a non-interventional, observational study with an optional interventional biobanking activity. Liver metastases of patients undergoing partial hepatectomy will be sampled completely while respecting the orientation used for medical imaging, in order to correlate the histopathological growth patterns in a 3D-map with the imaging characteristics. The full pathological sampling will only use remnant tissue.
Colon cancer is a major cause of death among different cancer types. The tumor in the colon can often be treated with curative intent (by surgery, possibly in combination with medication (chemotherapy)). However, in the vast majority of patients who die from colon cancer, metastases are the real cause of death. This usually involves liver metastases. These metastases can be surgically removed and patients are often treated peri-operatively with chemotherapy or other medication although this treatment is not always successful. The existing method, eg a clinical risk score, that is being used to predict which patient will benefit from a specific treatment of liver metastases is inaccurate.
Over the past fifteen years, the investigators of the Translational Cancer Research Unit have conducted research that explains, at least partly, why not all liver metastases from colon cancer behave in the same way. These differences can be observed by histopathological examination. Surprisingly, liver metastases behave in two very different ways, or growth patterns, and this information is currently not being used in clinical practice. However, the biological differences in the behavior of the cancer cells between these two growth patterns are pronounced. In one growth pattern - "desmoplastic" - the cancer cells behave as in the primary colon cancer itself: they form groups and create new supportive tissue - or "desmoplasia" - and blood vessels - or "angiogenesis". Inflammation is often present in this type of metastases. In the other growth pattern - 'replacement' - the cancer cells behave in a special way: they take the place of, or 'replace', the normal cells of the liver, the hepatocytes, and use the available supporting tissue and blood vessels of the host. There is no formation of new blood vessels and there is often little or no inflammation. When more than one growth pattern is present in a liver metastasis, the relative contribution of each growth pattern is estimated (percentage).
These different growth patterns contain important information on the success of the treatment of the individual patient. A large retrospective study of 732 patients, where liver metastases from colon cancer were surgically removed, identified a group of patients (19%) with an exclusive desmoplastic growth pattern in all sections of the resected liver metastasis. This subgroup is associated with good survival and progression-free survival. In contrast, patients with any amount of replacement growth, have a significantly shorter overall survival. However, large retrospective studies have shown that these patients with a 'replacement' growth pattern have a survival advantage of adjuvant treatment, i.e. after surgery for liver metastasis, often a combination of chemotherapy and a treatment that inhibits angiogenesis (for example bevacizumab) is given. This is in contrast to patients with the "desmoplastic" growth pattern, the intrinsically more favorable pattern, where this treatment has no survival benefit and is therefore probably not necessary after surgery. These patients may be the so-called "oligometastatic" patients who may benefit from repeated local targeted therapies. The prognostic and predictive value of the growth patterns has been demonstrated not only in patients with colorectal cancer but also in patients with uveal melanoma, skin melanoma and breast carcinoma.
The concept of tumor growth patterns is innovative (and still underexposed in the scientific literature) and offers important perspectives for clinical application. Anti-angiogenic treatment as well as immunotherapy achieved poor results in clinical studies of metastatic colon cancer. The investigators are convinced that a better selection of patients based on characteristics of the liver metastasis, and not only based on characteristics of the primary colon tumor, could lead to success in clinical studies.
Thus, the growth patterns have an important clinical value and provide the treating physician with yet unknown information about the behavior of a liver metastasis in an individual patient. The limitation, of course, is that the growth pattern can only be determined after hepatic surgery. It would be much more useful to be able to identify the growth patterns by means of medical imaging, allowing the treatment to be tailored to the patient even before surgery. (for example; is there an additional benefit of starting chemotherapy prior to surgery?) Therefore, the aim of the current project is to ascertain whether the investigators can identify the growth patterns of these tumors by means of imaging with CT (computed tomography) or MRI (nuclear spin tomography). Some published studies suggest that medical imaging can capture the histopathological growth patterns, but these are all retrospective studies with a small number of patients and incomplete pathological sampling of the liver metastases. One study in 2007 correlated the early peri-lesional gadolinium enhancement of the liver metastasis with the presence of the desmoplastic reaction with vascular proliferation and inflammation. More recently, a study of Cheng and colleagues claimed that the prediction of the growth patterns would be possible with radiomics based on CT images.
By identifying the growth patterns in a non-invasive manner, by means of medical imaging, the investigators will be able to use the growth patterns in prospective clinical studies to truly test the predictive power.
This project concerns liver metastases of primary colorectal carcinoma as well as primary breast carcinoma. The research will therefore mainly, but not only, help patients with liver metastases of colorectal cancer and breast cancer when a translation of this project from the pre-clinical phase (explorative study) to the clinical phase (randomized studies with patients) is done.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 50 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Cancer Research Antwerp is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with liver metastatic colorectal or breast carcinoma undergoing a surgical excision of the liver metastases
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiomics Analysis Pipeline The imaging analysis has been designed to predict the continuous proportion and spatial distribution of HGPs
Radiomics Analysis Pipeline The imaging analysis has been designed to predict the continuous proportion and spatial distribution of HGPs. CT will be the principal modality because it is routinely acquired in patients undergoing liver surgery and is more broadly available for subsequent validation. MRI will be analyzed in a complementary exploratory framework when anatomical sequences are available. Analyses will be performed at three linked spatial scales: (a) the entire metastasis and its concentric peritumoral environment; (b) localized CT patches corresponding to histologically mapped interface segments; and (c) the background liver as an organ-level biological context. Handcrafted radiomics, foundation-model embeddings and localized patch analysis will be used.
Time frame: 7 years
Plan to share: Undecided
Started Sep 2020 (actual). Primary completion is estimated for Dec 2027, 87 months after the start.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 87 months is above that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
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Cancer Research Antwerp