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Completed

NCT Number: NCT03546569

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

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.

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Key information

Conditions

Cancer of Colon Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zealand University Hospital

Køge, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Acronym: CISMO

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 6, 2018
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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