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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546569
Recruitment Status : Completed
First Posted : June 6, 2018
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Study Description
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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.


Condition or disease
Cancer of Colon

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 Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulation Tumor Cells, Tumor DNA and Immunological Response in Relation to Colonic Stent Placement for Malignant Obstruction
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : February 1, 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Immunological response [ Time Frame: 2 years ]
    Flow cytometry will be performed and additionally multiplex cytokine analyses will be performed

  2. Metastatic ability of the cancer cells [ Time Frame: 2 years ]
    Cell adhesion assay, proliferation and migration will be performed on serum.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546569


Locations
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Denmark
Zealand University Hospital
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
More Information
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03546569    
Other Study ID Numbers: REG-059-2017
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases