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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03546569|
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : June 5, 2018
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|
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|
|Estimated Enrollment :||20 participants|
|Official Title:||Circulation Tumor Cells, Tumor DNA and Immunological Response in Relation to Colonic Stent Placement for Malignant Obstruction|
|Actual Study Start Date :||May 16, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
- 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.
- Immunological response [ Time Frame: 2 years ]Flow cytometry will be performed and additionally multiplex cytokine analyses will be performed
- Metastatic ability of the cancer cells [ Time Frame: 2 years ]Cell adhesion assay, proliferation and migration will be performed on serum.
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
|Contact: Malene Broholm, email@example.com|
|Zealand University Hospital||Recruiting|
|Køge, Denmark, 4600|
|Contact: Malene Broholm, cand.med. 41272742 firstname.lastname@example.org|