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

Sponsor

Zealand University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03546569

Collaborator

(none)

Enrollment

Location

33.1

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

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 :

Jan 1, 2020

Actual Study Completion Date :

Feb 1, 2021

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Zealand University Hospital	Køge		Denmark	4600

Sponsors and Collaborators

Zealand University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zealand University Hospital

ClinicalTrials.gov Identifier:

NCT03546569

Other Study ID Numbers:

REG-059-2017

First Posted:

Jun 6, 2018

Last Update Posted:

Feb 25, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colonic Neoplasms

Study Results

No Results Posted as of Feb 25, 2021