Dental Study in Cancer Patients With Central Venous Catheters
| Tracking Information | |||||
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| First Received Date ICMJE | November 25, 2008 | ||||
| Last Updated Date | March 21, 2013 | ||||
| Start Date ICMJE | September 2012 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine the incidence of transient bacteremia and established blood-stream infections (BSIs) by oral microorganisms in cancer patients with CVCs after an invasive dental procedure [ Time Frame: Two days, 1 month, 6 months ] [ Designated as safety issue: Yes ] Blood cultures drawn before dental cleaning, 20 minutes after starting procedure, 30 minutes after finishing the procedure and at 24 hours after starting the procedure. Records reviewed at one month and six months post procedure for bloodstream or central venous catheter infection. |
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| Original Primary Outcome Measures ICMJE |
To determine the incidence of transient bacteremia and established blood-stream infections (BSIs) by oral microorganisms in cancer patients with CVCs after an invasive dental procedure [ Time Frame: Blood cultures drawn before dental cleaning, 20 minutes after starting procedure, 30 minutes after finishing the procedure and at 24 hours after the procedure. ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00798330 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dental Study in Cancer Patients With Central Venous Catheters | ||||
| Official Title ICMJE | Pilot Study on Transient Bacteremia and Blood Stream Infections After Invasive Dental Procedures in Cancer Patients With Central Venous Catheters | ||||
| Brief Summary | Patients who are preparing to receive chemotherapy are asked to have their teeth cleaned before starting treatment as standard of care. This research study is being done to see if having dental cleaning increases the chances of bacteria from the mouth getting into the blood stream. It is also being done to see if these bacteria can cause blood stream infections in people who have a Central Venous Catheter (often called a "port" or a "PICC") placed for giving chemotherapy. It is a well-established fact that we introduce bacteria from the mouth into the bloodstream with activities of daily life including chewing, flossing and brushing teeth. This introduction of bacteria into the blood stream may cause bacteria to stick to the central venous catheter and serve as a source of infection when the immune system is weakened by cancer. The purpose of this research study is to see if we can find bacteria from mouth in blood that is drawn through the port or PICC before, during, and after a dental cleaning procedure. This way, we will be able to assess whether or not this is a potential health risk to cancer patients. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Cancer outpatients with central venous catheters (Medport or PICC lines) |
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| Condition ICMJE | Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 27 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00798330 | ||||
| Other Study ID Numbers ICMJE | 09-059-2, 786-001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Rajesh Lalla, University of Connecticut Health Center | ||||
| Study Sponsor ICMJE | Rajesh Lalla | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Connecticut Health Center | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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