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

NCT ID: NCT03546569

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer of Colon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zealand University Hospital

Køge, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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REG-059-2017

Identifier Type: -

Identifier Source: org_study_id

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