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

Cancer of Colon Clinical Trial

— CISMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546569
• Other study ID #: REG-059-2017
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Colon
• Colonic Neoplasms

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ctDNA/cfDNA levels in relation to colorectal stent placement	Blood samples will be collected before the treatment and again 1, 4, 12 and 24 hours after stent placement.	2 years
Secondary	Immunological response	Flow cytometry will be performed and additionally multiplex cytokine analyses will be performed	2 years
Secondary	Metastatic ability of the cancer cells	Cell adhesion assay, proliferation and migration will be performed on serum.	2 years