NCT03546569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

May 22, 2018

Last Update Submit

February 24, 2021

Conditions

Cancer of Colon

Outcome Measures

Primary Outcomes (1)

  • ctDNA/cfDNA levels in relation to colorectal stent placement

    Blood samples will be collected before the treatment and again 1, 4, 12 and 24 hours after stent placement.

    2 years

Secondary Outcomes (2)

  • Immunological response

    2 years

  • Metastatic ability of the cancer cells

    2 years

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 6, 2018

Study Start

May 1, 2018

Primary Completion

January 1, 2020

Study Completion

February 1, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

DK(1)