CompletedNot Applicable

Tumor Cells, Tumor DNA and Immunological Response in Colonic Stent Placement

Denmark20 participantsStarted 2018-05-01

Plain-language summary

This study aims to investigate levels of circulating cell free DNA (cfDNA), circulating tumor DNA (ctDNA), circulating tumor cells (CTC) and immunological changes after self-expanding metal stent (SEMS) placement for malignant obstruction in the colon, and interpret these levels in relation to overall- and disease-free survival. Furthermore, we intend to study the opportunity to identify patients with a higher risk of recurrence due to the SEMS placement by monitoring cfDNA and ctDNA-levels, as it may be a potential biomarker to initiate or optimize chemotherapy and thereby ensure a better prognosis for the patients.

Who can participate

Age range18 Years – 95 Years

SexALL

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Inclusion Criteria: * Patients between the ages of 18 to 95 years * Patients with acute malignant obstruction in the colon. * ASA class I-III (Classification of the American Society of Anesthesiology) * Signed informed consent Exclusion Criteria: * Known immune-defects * Withdrawal of informed consent * Bloodtransfusion 24 hours prior to stent-placement until 24 hours after stent-placement. * Surgery within 24 hours after stent-placement * Known inflammatory bowel disease

What they're measuring

ctDNA/cfDNA levels in relation to colorectal stent placement

Timeframe: 2 years

Trial details

NCT IDNCT03546569

SponsorZealand University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-01-01

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