Tumor Cells, Tumor DNA and Immunological Response in Colonic Stent Placement (CISMO)

February 24, 2021 updated by: Zealand University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We intend to include 20 patients with malignant obstruction who are treated with a colorectal stent as bridge to surgery or as palliation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-059-2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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