Pancreatic Mass on ImagingNCT01241799
Yield of Endoscopic Ultrasound Guided Fine Needle Aspiration (EUS-FNA) With and Without the Use of a Stylet in the Biopsy Needle
A study testing Endoscopic ultrasound guided fine needle aspiration biopsy and Stylet out FNA first, Stylet in FNA second in people with Pancreatic Mass on Imaging, run by University of British Columbia at 1 site in Canada.
Trial summary
Purpose: To compare the diagnostic yield of endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNA) in patient with pancreatic masses with and without the use of a stylet in place within the biopsy needle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Mass on Imaging
- What is being tested?
- Endoscopic ultrasound guided fine needle aspiration biopsy and Stylet out FNA first, Stylet in FNA second
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Sep 2010
- Phase
- Interventional
- 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
Who may be able to join
- Patients 19 years of age and older
- Patients undergoing EUS FNA for solid lesions in the pancreas
Who cannot join
- Pancreatic cystic lesions without significant mass effect
- Pancreatic masses that cannot be accessed by transduodenal FNA in surgically resectable cases
- Known chronic pancreatitis with pancreaticolithiasis
- History of acute pancreatitis in the preceding 4 weeks
- History of gastric surgery or symptoms of gastric outlet obstruction
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Blinded, Randomized, Controlled Study to Compare the Yield of Endoscopic Ultrasound Guided Fine Needle Aspiration (EUS-FNA) With and Without the Use of a Stylet in the Biopsy Needle
Purpose:
To compare the diagnostic yield of endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNA) in patient with pancreatic masses with and without the use of a stylet in place within the biopsy needle.
Read more
Hypothesis:
In patients undergoing an EUS FNA for pancreatic indications, patients having a fine needle aspiration biopsy (FNA) without the internal stylet will have a greater diagnostic yield compared to those with the internal stylet.
Justification:
EUS-FNA is an increasingly important means of obtaining tissue samples from lesions within the thorax and abdomen. In experienced hands EUS-FNA is a safe alternative to more invasive procedures such as mediastinoscopy or laparoscopy. EUS-FNA can be used for sampling suspected cholangiocarcinoma, pancreatic masses or cysts, submucosal gastric lesions, peripancreatic, perigastric or mediastinal lymph nodes and in some cases adrenal or liver masses. Therefore, it is a powerful tool for both diagnosis and tumour staging. For example, for the diagnosis of pancreatic adenocarcinoma, which is a common indication for EUS-FNA, the sensitivity varies from 75 to >90%, with a specificity of 82-100% and a mean accuracy of 85%. Improving the diagnostic yield may lead to an earlier diagnosis with a reduced number of investigations and earlier institution of treatment for the patient.
The FNA needle system consists of a 22 or 19 gauge needle which is manipulated by a handle piston that attaches to the biopsy channel of the endoscopic ultrasound (EUS) linear scope. The tip of the needle has grooves to disperse ultrasound waves making the tip of the needle easily seen. The sample is taken by inserting a specially designed needle into the area of interest under EUS guidance. Inside the needle is a removable stylet with a rounded or bevelled tip to facilitate the passage of the needle into the tissue. The usual practice is for the stylet to be extracted after the needle has been passed into its optimum position within the tissue and for it to be re-inserted before each pass. However, a recent prospective trial with 111 patients, published in abstract form, found this approach was associated with a significant reduction in the proportion of adequate samples compared to when the stylet was removed before passing the needle. Although there was no significant difference in the diagnostic yield between the two groups this study raises the issue that the stylet left in place is to the detriment of the tissue sample and, ultimately, may reduce the diagnostic yield or increase the number of passes needed to obtain a satisfactory sample.
One limitation to this study includes the heterogenous patient population. Yields of EUS-FNA vary considerably depending on the type of tissue being biopsied. The second limitation is that consecutive patients were randomized to having the stylet removed versus having the stylet not removed at the time of FNA. There is no control group from which to compare the two groups. An improvement in the study design would be to have each patient to be their own control group. Successive passes of the FNA needle can increase the bloodiness of the sample, so randomization of the order in which each group is done will help eliminate potential bias.
It is clear from the current published literature that removing the stylet increases the cellularity of the sample. However, this increased cellularity may be the result of more contamination from the GI tract through which the FNA needle needs to pass in order to get an extra-luminal sample. Blood or a traumatic FNA can also lead to increased cellularity that can compromise diagnostic accuracy.
Diagnostic yield depends on both adequacy of the sample and enough cells from the lesion to interpret. A preliminary result based on an air dried slide often can lead to fewer FNA passes if a diagnosis can be made. If this is not possible, a cell block preparation is made from all the washings from the EUS-FNA needle. No study has examined the diagnostic accuracy of these two types of samples using an EUS-FNA needle with and without the stylet within the same patient.
Objectives:
To determine if the diagnostic yield of EUS-FNA is increased if the stylet is removed from the FNA needle compared with leaving it in place.
Read the detailed description
Research Method:
All patients referred for EUS who are also likely to require FNA will be screened for study eligibility by way of the inclusion and exclusion criteria. After informed consent has been obtained patients will be randomized to 2 different groups by random number generation
- Stylet in FNA first, Stylet out FNA second
- Stylet out FNA first, Stylet in FNA second As each method of tissue sampling will be used for all patients they will effectively act as their own controls.
In patients randomized to the first group the stylet in is left in place within the needle for the first three passes of the needle into the area to be sampled. A new 22 gauge EUS FNA is then used to obtain the FNA with the stylet out.
In patients randomized to the second group a 22 gauge EUS FNA needle with the stylet out is used for the first three passes. A new needle with the stylet in is subsequently used for further sampling. Three passes will be done for each FNA biopsy.
For each patient the sample adequacy, the number of bloody passes and the number of passes required to obtain an adequate sample will be recorded by the cytopathology technician. Each tissue sample will be prepared and analysed by experienced on-site cytopathology staff, who will be blinded to the group allocation of the respective patients. A positive or negative diagnosis will be recorded when the final cytology result is available. At the end of the study period a comparison between the two groups will be made in relation to the parameters outlined above.
Statistical Analysis:
Endpoints:
The primary endpoint of our study will be the number of samples with a positive diagnosis in each group. Secondary end-points will be the number of bloody passes, the sample adequacy and the number of passes needed to obtain an adequate sample.
Sample size calculation:
The outcome will be represented as a proportion of FNA samples that have a positive diagnosis. The effect size between the stylet in FNA and stylet out FNA is expected to be 30%. This is at a significance level of p= 0.05 and 80% power. The number of patients in each arm is therefore 36.
Description of methodology All patients who are referred for a pancreatic EUS and are likely to require an FNA will be identified and screened for eligibility for entry into the study according to the inclusion and exclusion criteria. Those patients who are seen in the office prior to an EUS appointment will be invited to enter the study by a research nurse or research assistant not involved with the procedure. They will be provided with written and verbal information on the study prior to making their decision. For patients who are referred directly for an EUS-FNA from another physician and who are not seen in the office beforehand a written invitation to enter the study will be sent in advance. This will provide detailed information on the research proposal as well as a helpline number which patients can use to contact one of the study co-ordinators for further advice. A follow up phone call to patients will be made by a study co-ordinator before they attend for the EUS; the initial contact letter will outline when this call will be made, and by whom.
If patients elect to enter into the study informed consent will be obtained prior to randomization.
Summary of procedures In patients randomized to the first group, under intravenous sedation, a linear endoscopic ultrasound examination is performed. The pancreatic mass is identified by endoscopic ultrasound and using a 22 gauge EUS FNA needle with the stylet in is used for the first pass. The stylet is then withdrawn and 10cc of suction is applied to the FNA needle. A sample is obtained by moving the needle in and out of the lesion for a minimum of 15 times. The sample is then collected for cytopathology. The stylet is replaced in the needle and another pass is performed by the same technique. Three passes will be done for each FNA biopsy. A new 22 gauge EUS FNA is then used to obtain the FNA with the stylet out by the same technique as outlined above.
In patients randomized to the second group, under intravenous sedation a linear endoscopic ultrasound examination is performed. The pancreatic mass is identified by endoscopic ultrasound and using a 22 gauge EUS FNA needle with the stylet out is used for the first pass. The stylet is then withdrawn and 10cc of suction is applied to the FNA needle. A sample is obtained by moving the needle in and out of the lesion for a minimum of 15 times. The sample is then collected for cytopathology. The stylet is replaced in the needle and once loaded into position, the stylet is removed prior to starting another pass performed by the same technique. Three passes will be done for each FNA biopsy.
Adverse events that can potentially occur include oversedation (1:500), pancreatitis (1:1000), perforation (1:5000), and bleeding (extremely rare with only one reported case in press) For each patient the sample adequacy, the number of bloody passes and the number of passes required to obtain an adequate sample will be recorded by the cytopathology technician. Each tissue sample will be prepared and analysed by experienced on-site cytopathology staff, who will be blinded to the group allocation of the respective patients. A positive or negative diagnosis will be recorded when the final cytology result is available. At the end of the study period a comparison between the two groups will be made in relation to the parameters outlined above.
Follow-up:
Within one day, all patients will be contacted to determine if any adverse events have occurred.
- Conditions
- Pancreatic Mass on Imaging
- Being tested
- Endoscopic ultrasound guided fine needle aspiration biopsy, Stylet out FNA first, Stylet in FNA second
- Keywords
- endoscopic ultrasound guided fine needle aspiration (EUS-FNA), pancreatic biopsy, randomized, single blind, fine needle aspiration (FNA) adequacy, fine needle aspiration (FNA) accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound guided fine needle aspiration biopsyProcedure or surgery
22 gauge fine needle aspiration biopsy of the pancreatic mass with the stylet in. Vacuum suction applied. 12 intra mass needle passes done. A new 22 gauge FNA biopsy needle with the style out is then used to biopsy the pancreatic mass. Vacuum suction applied. 12 intra mass needle masses done.
Stylet out FNA first, Stylet in FNA secondProcedure or surgery
22 gauge FNA biopsy of pancreatic mass with the stylet out. Vacuum suction applied. 12 intra mass needle passes done. A new 22 gauge FNA biopsy needle with the stylet in is used to biopsy the pancreatic mass. Vacuum suction applied. 12 intra mass needle passes done.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pancreatic biopsy with stylet in then stylet out Receives: Procedure: Endoscopic ultrasound guided fine needle aspiration biopsy |
| 2 | Experimental | Pancreatic biopsy with stylet out then stylet in Receives: Procedure: Stylet out FNA first, Stylet in FNA second |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of our study will be the number of samples with a positive diagnosis in each group
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startDec 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Mass on ImagingStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Eric Lam, Dr., Principal investigator, University of British ColumbiaJennifer Telford, Dr., Study director, University of British ColumbiaMark McLoughlin, Dr., Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241799
- Sponsor's protocol ID
- H08-01481
- Status last verified
- Nov 2010
- First submitted
- 12 Nov 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Blinded, Randomized, Controlled Study to Compare the Yield of Endoscopic Ultrasound Guided Fine Needle Aspiration (EUS-FNA) With and Without the Use of a Stylet in the Biopsy Needle
- ClinicalTrials.gov ID
- NCT01241799
- Acronym / sponsor ID
- H08-01481
- Conditions
- Pancreatic Mass on Imaging
- Keywords
- endoscopic ultrasound guided fine needle aspiration (EUS-FNA), pancreatic biopsy, randomized, single blind, fine needle aspiration (FNA) adequacy, fine needle aspiration (FNA) accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Nov 2010 (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.
Purpose:
To compare the diagnostic yield of endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNA) in patient with pancreatic masses with and without the use of a stylet in place within the biopsy needle.
Hypothesis:
In patients undergoing an EUS FNA for pancreatic indications, patients having a fine needle aspiration biopsy (FNA) without the internal stylet will have a greater diagnostic yield compared to those with the internal stylet.
Justification:
EUS-FNA is an increasingly important means of obtaining tissue samples from lesions within the thorax and abdomen. In experienced hands EUS-FNA is a safe alternative to more invasive procedures such as mediastinoscopy or laparoscopy. EUS-FNA can be used for sampling suspected cholangiocarcinoma, pancreatic masses or cysts, submucosal gastric lesions, peripancreatic, perigastric or mediastinal lymph nodes and in some cases adrenal or liver masses. Therefore, it is a powerful tool for both diagnosis and tumour staging. For example, for the diagnosis of pancreatic adenocarcinoma, which is a common indication for EUS-FNA, the sensitivity varies from 75 to >90%, with a specificity of 82-100% and a mean accuracy of 85%. Improving the diagnostic yield may lead to an earlier diagnosis with a reduced number of investigations and earlier institution of treatment for the patient.
The FNA needle system consists of a 22 or 19 gauge needle which is manipulated by a handle piston that attaches to the biopsy channel of the endoscopic ultrasound (EUS) linear scope. The tip of the needle has grooves to disperse ultrasound waves making the tip of the needle easily seen. The sample is taken by inserting a specially designed needle into the area of interest under EUS guidance. Inside the needle is a removable stylet with a rounded or bevelled tip to facilitate the passage of the needle into the tissue. The usual practice is for the stylet to be extracted after the needle has been passed into its optimum position within the tissue and for it to be re-inserted before each pass. However, a recent prospective trial with 111 patients, published in abstract form, found this approach was associated with a significant reduction in the proportion of adequate samples compared to when the stylet was removed before passing the needle. Although there was no significant difference in the diagnostic yield between the two groups this study raises the issue that the stylet left in place is to the detriment of the tissue sample and, ultimately, may reduce the diagnostic yield or increase the number of passes needed to obtain a satisfactory sample.
One limitation to this study includes the heterogenous patient population. Yields of EUS-FNA vary considerably depending on the type of tissue being biopsied. The second limitation is that consecutive patients were randomized to having the stylet removed versus having the stylet not removed at the time of FNA. There is no control group from which to compare the two groups. An improvement in the study design would be to have each patient to be their own control group. Successive passes of the FNA needle can increase the bloodiness of the sample, so randomization of the order in which each group is done will help eliminate potential bias.
It is clear from the current published literature that removing the stylet increases the cellularity of the sample. However, this increased cellularity may be the result of more contamination from the GI tract through which the FNA needle needs to pass in order to get an extra-luminal sample. Blood or a traumatic FNA can also lead to increased cellularity that can compromise diagnostic accuracy.
Diagnostic yield depends on both adequacy of the sample and enough cells from the lesion to interpret. A preliminary result based on an air dried slide often can lead to fewer FNA passes if a diagnosis can be made. If this is not possible, a cell block preparation is made from all the washings from the EUS-FNA needle. No study has examined the diagnostic accuracy of these two types of samples using an EUS-FNA needle with and without the stylet within the same patient.
Objectives:
To determine if the diagnostic yield of EUS-FNA is increased if the stylet is removed from the FNA needle compared with leaving it in place.
Detailed description
Research Method:
All patients referred for EUS who are also likely to require FNA will be screened for study eligibility by way of the inclusion and exclusion criteria. After informed consent has been obtained patients will be randomized to 2 different groups by random number generation
- Stylet in FNA first, Stylet out FNA second
- Stylet out FNA first, Stylet in FNA second As each method of tissue sampling will be used for all patients they will effectively act as their own controls.
In patients randomized to the first group the stylet in is left in place within the needle for the first three passes of the needle into the area to be sampled. A new 22 gauge EUS FNA is then used to obtain the FNA with the stylet out.
In patients randomized to the second group a 22 gauge EUS FNA needle with the stylet out is used for the first three passes. A new needle with the stylet in is subsequently used for further sampling. Three passes will be done for each FNA biopsy.
For each patient the sample adequacy, the number of bloody passes and the number of passes required to obtain an adequate sample will be recorded by the cytopathology technician. Each tissue sample will be prepared and analysed by experienced on-site cytopathology staff, who will be blinded to the group allocation of the respective patients. A positive or negative diagnosis will be recorded when the final cytology result is available. At the end of the study period a comparison between the two groups will be made in relation to the parameters outlined above.
Statistical Analysis:
Endpoints:
The primary endpoint of our study will be the number of samples with a positive diagnosis in each group. Secondary end-points will be the number of bloody passes, the sample adequacy and the number of passes needed to obtain an adequate sample.
Sample size calculation:
The outcome will be represented as a proportion of FNA samples that have a positive diagnosis. The effect size between the stylet in FNA and stylet out FNA is expected to be 30%. This is at a significance level of p= 0.05 and 80% power. The number of patients in each arm is therefore 36.
Description of methodology All patients who are referred for a pancreatic EUS and are likely to require an FNA will be identified and screened for eligibility for entry into the study according to the inclusion and exclusion criteria. Those patients who are seen in the office prior to an EUS appointment will be invited to enter the study by a research nurse or research assistant not involved with the procedure. They will be provided with written and verbal information on the study prior to making their decision. For patients who are referred directly for an EUS-FNA from another physician and who are not seen in the office beforehand a written invitation to enter the study will be sent in advance. This will provide detailed information on the research proposal as well as a helpline number which patients can use to contact one of the study co-ordinators for further advice. A follow up phone call to patients will be made by a study co-ordinator before they attend for the EUS; the initial contact letter will outline when this call will be made, and by whom.
If patients elect to enter into the study informed consent will be obtained prior to randomization.
Summary of procedures In patients randomized to the first group, under intravenous sedation, a linear endoscopic ultrasound examination is performed. The pancreatic mass is identified by endoscopic ultrasound and using a 22 gauge EUS FNA needle with the stylet in is used for the first pass. The stylet is then withdrawn and 10cc of suction is applied to the FNA needle. A sample is obtained by moving the needle in and out of the lesion for a minimum of 15 times. The sample is then collected for cytopathology. The stylet is replaced in the needle and another pass is performed by the same technique. Three passes will be done for each FNA biopsy. A new 22 gauge EUS FNA is then used to obtain the FNA with the stylet out by the same technique as outlined above.
In patients randomized to the second group, under intravenous sedation a linear endoscopic ultrasound examination is performed. The pancreatic mass is identified by endoscopic ultrasound and using a 22 gauge EUS FNA needle with the stylet out is used for the first pass. The stylet is then withdrawn and 10cc of suction is applied to the FNA needle. A sample is obtained by moving the needle in and out of the lesion for a minimum of 15 times. The sample is then collected for cytopathology. The stylet is replaced in the needle and once loaded into position, the stylet is removed prior to starting another pass performed by the same technique. Three passes will be done for each FNA biopsy.
Adverse events that can potentially occur include oversedation (1:500), pancreatitis (1:1000), perforation (1:5000), and bleeding (extremely rare with only one reported case in press) For each patient the sample adequacy, the number of bloody passes and the number of passes required to obtain an adequate sample will be recorded by the cytopathology technician. Each tissue sample will be prepared and analysed by experienced on-site cytopathology staff, who will be blinded to the group allocation of the respective patients. A positive or negative diagnosis will be recorded when the final cytology result is available. At the end of the study period a comparison between the two groups will be made in relation to the parameters outlined above.
Follow-up:
Within one day, all patients will be contacted to determine if any adverse events have occurred.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Endoscopic ultrasound guided fine needle aspiration biopsyPancreatic biopsy with stylet in then stylet out |
| 2 | Experimental | Procedure: Stylet out FNA first, Stylet in FNA secondPancreatic biopsy with stylet out then stylet in |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 19 years of age and older
- Patients undergoing EUS FNA for solid lesions in the pancreas
Key exclusion criteria (6 listed)
- Pancreatic cystic lesions without significant mass effect
- Pancreatic masses that cannot be accessed by transduodenal FNA in surgically resectable cases
- Known chronic pancreatitis with pancreaticolithiasis
- History of acute pancreatitis in the preceding 4 weeks
- History of gastric surgery or symptoms of gastric outlet obstruction
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 |
|---|---|---|
| Endoscopic ultrasound guided fine needle aspiration biopsy22 gauge fine needle aspiration biopsy of the pancreatic mass with the stylet in. Vacuum suction applied. 12 intra mass needle passes done. A new 22 gauge FNA biopsy needle with the style out is then used to biopsy the pancreatic mass. Vacuum suction applied. 12 intra mass needle masses done. | Procedure or surgery | 1 |
| Stylet out FNA first, Stylet in FNA second22 gauge FNA biopsy of pancreatic mass with the stylet out. Vacuum suction applied. 12 intra mass needle passes done. A new 22 gauge FNA biopsy needle with the stylet in is used to biopsy the pancreatic mass. Vacuum suction applied. 12 intra mass needle passes done. | Procedure or surgery | 2 |
Primary outcome
The primary endpoint of our study will be the number of samples with a positive diagnosis in each group
Time frame: 1 day
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 24 Nov 2010.
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.
Eric Lam, Dr. principal investigator
University of British Columbia
Jennifer Telford, Dr. study director
University of British Columbia
Mark McLoughlin, Dr. study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound guided fine needle aspiration biopsy and Stylet out FNA first, Stylet in FNA second in people with Pancreatic Mass on Imaging, run by University of British Columbia at 1 site in Canada.
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 6 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 24 Nov 2010. 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 Canada. 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?
The primary endpoint of our study will be the number of samples with a positive diagnosis in each group (time frame: 1 day). 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 24 Nov 2010.