Cancer of ColonCISMONCT03546569
Tumor Cells, Tumor DNA and Immunological Response in Colonic Stent Placement
An observational study of Cancer of Colon, run by Zealand University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cancer of Colon
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulation Tumor Cells, Tumor DNA and Immunological Response in Relation to Colonic Stent Placement for Malignant Obstruction
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.
Read the 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.
- Conditions
- Cancer of Colon
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Immunological response
Flow cytometry will be performed and additionally multiplex cytokine analyses will be performed
Measured: 2 years
Metastatic ability of the cancer cells
Cell adhesion assay, proliferation and migration will be performed on serum.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 May 2018
- Primary completion1 Jan 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546569
- Sponsor's protocol ID
- REG-059-2017
- Acronym
- CISMO
- Status last verified
- Feb 2021
- First submitted
- 22 May 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulation Tumor Cells, Tumor DNA and Immunological Response in Relation to Colonic Stent Placement for Malignant Obstruction
- ClinicalTrials.gov ID
- NCT03546569
- Acronym / sponsor ID
- CISMO / REG-059-2017
- Conditions
- Cancer of Colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Immunological response
Time frame: 2 years
Metastatic ability of the cancer cells
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Colon, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA/cfDNA levels in relation to colorectal stent placement (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.