OncologyNCT03855969
Central Venous Access Device Removal in Cancer Patients
An observational study of Oncology and Haematological Malignancy, run by General Hospital Groeninge at 1 site in Belgium.
Trial summary
Background: Central venous catheters are frequently used during cancer treatment with the aim of venepreservation. It can facilitate venous access for the safe administration of irritating or vesicant intravenous cancer medications and / or other fluids, to collect blood samples or to ensure accurate venous access for… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oncology, Haematological Malignancy
- What is being tested?
- Removal of a central venous access device
- Type of treatment
- Surgery or procedure
- How many people
- 1,402 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 30 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We are interested in cancer patients who were implanted a central venous access device with regard to their cancer treatment, but for which the device was removed.
Who may be able to join
- Central venous access device removal in our general hospital
- Cancer patient
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency of Central Venous Port Catheter Removal Due to Suspected Infection in Patients Diagnosed With Cancer at a Single Institution: A Retrospective Study.
Background:
Central venous catheters are frequently used during cancer treatment with the aim of venepreservation. It can facilitate venous access for the safe administration of irritating or vesicant intravenous cancer medications and / or other fluids, to collect blood samples or to ensure accurate venous access for contrast during medical imaging. In addition, this means more comfort for the patient who needs to be punctured less peripherally. However, central venous catheters can also be a source of bloodstream infections and other complications, leading to increased morbidity and hospital costs (1). In our hospital, there is a general practice that if an infection of the device is suspected, the central venous catheter should be removed if antibiotics do not seem or prove to be effective.
Read more
The objective of this trial is to assess the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device in a particular oncology center over a time period of seven years. Furthermore, evidence for real device infections (per/post-surgery) and the potential contribution of different (institution-specific) risk factors on device infection will be explored. There will be focused on implanted port catheters only, as this is the main used central venous access device within the oncological population.
Trial objectives:
The primary aim of this retrospective descriptive trial is to evaluate the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device, over a time period of seven years.
The secondary aim is to examine whether the device infection could be confirmed during or after removal of the device.
At last, the tertiary aim is to verify whether certain variables can be denoted as potential risk factors for central venous access infection. Selection of those variables of interest will be based on a thorough review of the literature and discussion with the responsible healthcare professionals.
- Conditions
- Oncology, Haematological Malignancy
- Being tested
- Removal of a central venous access device
- Keywords
- PAC infections, oncology
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of a central venous access deviceProcedure or surgery
We are interested in those patients for which a central venous access device was removed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Suspected infection rate
How many central venous access devices are removed due to a suspected infection of the device in cancer patients.
Measured: 2012-2017
Secondary outcomes (2)
Approved infection rate
For how many of the central venous access devices that were removed due to suspected infection of the device could an infection be confirmed?
Measured: 2012-2017
Risk factors for central venous access device infections in cancer patients
Is it possible to denote certain variables as potential risk factors for central venous access device infection?
Measured: 2012-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Mar 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Groeninge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Van Eygen, General Hospital Groeninge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855969
- Sponsor's protocol ID
- AZGS2018106
- Status last verified
- Aug 2020
- First submitted
- 25 Feb 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publically and shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Central Venous Port Catheter Removal Due to Suspected Infection in Patients Diagnosed With Cancer at a Single Institution: A Retrospective Study.
- ClinicalTrials.gov ID
- NCT03855969
- Acronym / sponsor ID
- AZGS2018106
- Conditions
- Oncology, Haematological Malignancy
- Keywords
- PAC infections, oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,402 participants (actual)
- Lead sponsor
- General Hospital GroeningeUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 27 Feb 2019 (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.
Background:
Central venous catheters are frequently used during cancer treatment with the aim of venepreservation. It can facilitate venous access for the safe administration of irritating or vesicant intravenous cancer medications and / or other fluids, to collect blood samples or to ensure accurate venous access for contrast during medical imaging. In addition, this means more comfort for the patient who needs to be punctured less peripherally. However, central venous catheters can also be a source of bloodstream infections and other complications, leading to increased morbidity and hospital costs (1). In our hospital, there is a general practice that if an infection of the device is suspected, the central venous catheter should be removed if antibiotics do not seem or prove to be effective.
The objective of this trial is to assess the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device in a particular oncology center over a time period of seven years. Furthermore, evidence for real device infections (per/post-surgery) and the potential contribution of different (institution-specific) risk factors on device infection will be explored. There will be focused on implanted port catheters only, as this is the main used central venous access device within the oncological population.
Trial objectives:
The primary aim of this retrospective descriptive trial is to evaluate the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device, over a time period of seven years.
The secondary aim is to examine whether the device infection could be confirmed during or after removal of the device.
At last, the tertiary aim is to verify whether certain variables can be denoted as potential risk factors for central venous access infection. Selection of those variables of interest will be based on a thorough review of the literature and discussion with the responsible healthcare professionals.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We are interested in cancer patients who were implanted a central venous access device with regard to their cancer treatment, but for which the device was removed.
Key inclusion criteria (2 listed)
- Central venous access device removal in our general hospital
- Cancer patient
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of a central venous access deviceWe are interested in those patients for which a central venous access device was removed. | Procedure or surgery | – |
Primary outcome
Suspected infection rate
Time frame: 2012-2017
How many central venous access devices are removed due to a suspected infection of the device in cancer patients.
2 secondary outcomes
Approved infection rate
Time frame: 2012-2017
Risk factors for central venous access device infections in cancer patients
Time frame: 2012-2017
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 5 Aug 2020.
- Individual participant dataSharing planned: No. Individual participant data will not be made publically and shared with other researchers.
Related trials for Oncology
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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 Oncology and Haematological Malignancy, run by General Hospital Groeninge at 1 site in Belgium.
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 2 inclusion and 1 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 5 Aug 2020. 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 Belgium. 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?
Suspected infection rate (time frame: 2012-2017). 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 5 Aug 2020.