The goal of this study is to develop a blood-test which can detect colorectal cancer in early stages. Participants will be asked to take an extra blood test, which will be analyzed further in the lab.
Lynch Syndrome (LS) carriers have a predisposition to develop various types of cancer, especially colorectal cancer (CRC) and endometrial cancer (EC). LS patients are advised to undergo surveillance by colonoscopy every 2 year and gynaecological surveillance. This surveillance is deemed burdensome and fails to detect a small part of the developing CRCs and the majority of extra-colonic cancers. To ensure prevention and early detection of cancer, a reliable and accessible test is needed. Recent studies have shown the potential of the detection of tumor-derived DNA fragments (circulating tumor DNA; ctDNA). Various molecular characteristics can be used to discriminate ctDNA from healthy circulating cell-free DNA. Current ctDNA assays with the highest sensitivity and specificity to detect for example minimal residual disease (MRD) after surgery are mostly tumor-informed, which means prior information is needed from the tumor tissue about the molecular alterations present. As this information is not available for the detection of newly arising tumors, the aim of this study is to evaluate the use of an optimized combination of tumor agnostic ctDNA characteristics for the detection of newly developing tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
50
An (extra) blood test will be done on participants. This will be analyzed for circulating tumor DNA (ctDNA) via a multi-omics approach.
Leiden University Medical Center
Leiden, South Holland, Netherlands
NOT_YET_RECRUITINGErasmus MC
Rotterdam, South Holland, Netherlands
RECRUITINGEstimated ctDNA fractions in blood
ctDNA presence will be measured against a (presently not specified) threshold, creating a divide between 'detectable' and 'non-detectable'.
Time frame: Measurement at baseline
Tumor pathology
Tumor pathology will be revised to later compare with estimated ctDNA presence.
Time frame: Measurement at baseline
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