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

Completed

• Conditions: Cancer of Colon

• Registration Number: NCT03546569
• Lead Sponsor: Zealand University Hospital

Brief 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.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-06
• Primary Completion: 2020-01-01
• Status Verified: 2021-02
• Study Completion: 2021-02-01
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ctDNA/cfDNA levels in relation to colorectal stent placement	2 years	Blood samples will be collected before the treatment and again 1, 4, 12 and 24 hours after stent placement.

Secondary Outcome Measures

Name	Time	Method
Metastatic ability of the cancer cells	2 years	Cell adhesion assay, proliferation and migration will be performed on serum.
Immunological response	2 years	Flow cytometry will be performed and additionally multiplex cytokine analyses will be performed

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Køge, Denmark