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About
In this proof-of-concept trial the investigators will study the effects of imatinib treatment on the biology of mesenchymal-type colon cancers.
Full description
Tumor biopsies from patients with newly diagnosed colon cancer will be pre-screened with an RT-qPCR test to identify tumors of the mesenchymal subtype. Patients with mesenchymal-type tumors that meet the in- and exclusion criteria will be treated with imatinib during the "window period" that normally precedes surgery. Immediately following tumor resection, biopsies will be taken from the surgical specimen. Gene and protein expression of the pre- and post-treatments biopsies will be compared to assess the effects of imatinib therapy on PDGFR- and cKIT-signalling and on the mesenchymal gene expression profile.
Enrollment
Sex
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Volunteers
Inclusion criteria
Male or female aged ≥18 years
Histologically proven adenocarcinoma of the colon;
Completed cancer staging with CT-abdomen and CT-thorax/X-thorax according to hospital's standard of care;
Confirmed eligibility for surgery with curative intent as deemed by the hospital's multidisciplinary board (MDB) review;
An intratumoural gene expression profile of PDGFR-α, PDGFR-β, PDGF-C and KIT, indicative of the mesenchymal phenotype, according to our diagnostic RT-qPCR test (i.e. more than 50% chance of having the mesenchymal phenotype);
Minimum of four properly stored pre-treatment biopsies for gene expression analysis/ELISA;
WHO performance status 0 or 1;
Adequate haematology status and organ function, defined as:
Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests;
Written informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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