NCT03546569

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

Circulation Tumor Cells, Tumor DNA and Immunological Response in Relation to Colonic Stent Placement for Malignant Obstruction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study design This prospective study will include 20 patients undergoing SEMS placement as a bridge to elective surgery at Koege- and Slagelse Hospital. Baseline blood samples will be collected before the procedure. After the procedure blood samples will be collected 1, 4, 12 and 24 hours after SEMS placement. After elective surgery a tumor sample will be collected. Prior to SEMS placement: When potential candidates are admitted to the hospital they will be presented to the study by the relevant surgeon. The investigators will be contacted, when the patient is admitted to hospital.

Conditions

• Cancer of Colon

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-01-01
• Completion: 2021-02-01
• First posted: 2018-06-06
• Last updated: 2021-02-25

Locations

1 site across 1 country: Denmark