CancerCCINCT00921141
Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports
An observational study of Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
This is a prospective, descriptive and observational study of the anticancer center practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 815 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Apr 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients requiring the implementation of a catheter in an anticancerous center
Who may be able to join
- Patient with any cancer, requiring a central venous catheter
- No contraindication for any surgery with local or complete anaesthesia
Who cannot join
- Previous Xylocaine or Lidocaine allergy
- Clinic superior vena cava syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports : Cohort and Prospective Study
This is a prospective, descriptive and observational study of the anticancer center practice
- Conditions
- Cancer
- Keywords
- Implantable central venous access ports, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study population | Patient with cancer requiring a long-term central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and collection of complications for the patients requiring an implantable central venous access ports substitution/change
Measured: Until the implantable central venous access ports removal
Secondary outcomes (3)
Brief description of the different risk factor for morbidity
Measured: Until the implantable central venous access ports removal
Assessment of the implantable central venous access ports ease-of-use for nurses according to the modalities of implementation and patient features
Measured: Until the implantable central venous access ports removal
Assessment of the patient quality of life
Measured: Before central venous access ports implementation, at the first day of chemotherapy, and during the cycle 4 of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startMay 2006
- Primary completionApr 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice NARDUCCI, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921141
- Sponsor's protocol ID
- CCI
- Other IDs
- CCI
- Acronym
- CCI
- Status last verified
- Jul 2012
- First submitted
- 15 Jun 2009
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports : Cohort and Prospective Study
- ClinicalTrials.gov ID
- NCT00921141
- Acronym / sponsor ID
- CCI / CCI
- Conditions
- Cancer
- Keywords
- Implantable central venous access ports, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 Jun 2009 (estimated)
- 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 is a prospective, descriptive and observational study of the anticancer center practice
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study population | – | –Patient with cancer requiring a long-term central venous catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients requiring the implementation of a catheter in an anticancerous center
Key inclusion criteria (2 listed)
- Patient with any cancer, requiring a central venous catheter
- No contraindication for any surgery with local or complete anaesthesia
Key exclusion criteria (2 listed)
- Previous Xylocaine or Lidocaine allergy
- Clinic superior vena cava syndrome
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
Incidence and collection of complications for the patients requiring an implantable central venous access ports substitution/change
Time frame: Until the implantable central venous access ports removal
3 secondary outcomes
Brief description of the different risk factor for morbidity
Time frame: Until the implantable central venous access ports removal
Assessment of the implantable central venous access ports ease-of-use for nurses according to the modalities of implementation and patient features
Time frame: Until the implantable central venous access ports removal
Assessment of the patient quality of life
Time frame: Before central venous access ports implementation, at the first day of chemotherapy, and during the cycle 4 of chemotherapy
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 23 Jul 2012.
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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.
Fabrice NARDUCCI, MD principal investigator
Centre Oscar Lambret
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, run by Centre Oscar Lambret at 1 site in France.
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 2 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 23 Jul 2012. 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 France. 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?
Incidence and collection of complications for the patients requiring an implantable central venous access ports substitution/change (time frame: Until the implantable central venous access ports removal). 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 23 Jul 2012.