Intestinal MetaplasiaPhase 1pCLE-GCEPNCT01398579
Comparison Between Probe-based Confocal Laser Endomicroscopy, White-light Endoscopy and Virtual Chromoendoscopy
A Phase 1 study testing Gastroscopy in people with Intestinal Metaplasia and Intestinal Dysplasia, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The investigators hypothesis that 1. clinical applicability and overall diagnostic sensitivity and specificity of pCLE for diagnosing gastric preneoplastic and neoplastic lesions is acceptable 2. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Intestinal Metaplasia, Intestinal Dysplasia
- What is being tested?
- Gastroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2011to Sep 2012
- Phase
- Phase 1
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is Chinese
- The subject is greater than 50 years of age
- The subject satisfies one or more of the following criteria:
- has (had) a history of dyspepsia of at least 4 weeks or more. Dyspeptic symptoms include bloating, epigastric discomfort and early satiety
- has a family history of gastric cancer
- has a medical condition for which an OGD is indicated.
Show all 9Show fewer
- Has past history of intestinal metaplasia or dysplasia
- The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
- The subject must be willing and able to comply with scheduled visits and other study procedures
Who cannot join
- patients who cannot undergo gastroscopies
- have a personal history of stomach cancer or surgery
- any disabling illnesses
- are pregnant or breast-feeding
- have bronchial asthma or a known allergy to fluorescein
- have renal impairment with serum creatinine above the upper limit of normal
- have uncorrected coagulopathy or severe thrombocytopenia precluding biopsy
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 119974
Lee Guan Lim, Doctor, 67795555, lee_guan_lim@nuhs.edu.sg
About this study
Official title: Prospective Comparison Between Probe-based Confocal Laser Endomicroscopy, White-light Endoscopy and Virtual Chromoendoscopy for the Diagnosis of Gastric Pre-neoplastic and Neoplastic Lesions (pCLE-GCEP)
The investigators hypothesis that
- clinical applicability and overall diagnostic sensitivity and specificity of pCLE for diagnosing gastric preneoplastic and neoplastic lesions is acceptable
- pCLE, as compared to white-light endoscopy (WLE), AFI and magnifying NBI has higher sensitivity and specificity for the diagnosing gastric pre-neoplastic and neoplastic lesions
Read the detailed description
Patients will be recruited from an ongoing study - Gastric Cancer Epidemiology, Clinical and Genetic Programme Cohort Study (GCEP). GCEP is a prospective cohort study aiming to enroll 3,000 Singapore- Chinese subjects aged >50 years, and offers screening by endoscopy and systematic follow-up for a minimum of 5 years. 20 patients will be randomized into two groups. All of them will be examined using four different endoscopy imaging technologies by one trained specialist. 10 patients will be in group A and another 10 patients will be in group B. Group A: WLE followed by AFI followed by NBI followed by pCLE. Group B: WLE followed by NBI followed by AFI followed by pCLE. The difference between two groups is the sequence of two endoscopy imaging modes - AFI and NBI. Diagnosis made during NBI and AFI must be made based on pre-defined criteria, and should not be influenced by the preceding imaging modality. To control for the possible bias on the third imaging modality caused by influence from the preceding imaging modality, patients are randomized to receive NBI before AFI or AFI before NBI.
Endoscopic diagnosis will be made for each suspected lesion with every imaging modality. The biopsy of lesions will be taken after pCLE examination is completed and sent for histology. In the absence of suspicious lesions, the area of examination will be as follows (as stated in main GCEP protocol):
- A1- lesser curvature of the antrum, within 2-3cm of the pylorus.
- A2- greater curvature of the antrum, within 2-3cm of the pylorus.
- IA- incisura angularis.
- B1- lesser curvature of the corpus, 4cm proximal to the angulus.
- B2- middle portion of the greater curvature of the corpus, 8cm from the cardia.
- Cardia (C) - within 1 cm below the OGJ (defined as the point where gastric folds disappear).
The results will be compared with the gold standard diagnosis - histopathology diagnosis. The sensitivity and specificity for each imaging tool will be calculated accordingly.
- Conditions
- Intestinal Metaplasia, Intestinal Dysplasia
- Being tested
- Gastroscopy
- Keywords
- intestinal metaplasia, dysplasia, probe-based confocal endomicroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastroscopyProcedure or surgery
Also called OGD
20 patients will be randomized into two groups. All of them will be examined using four different endoscopy imaging technologies by one trained specialist. 10 patients will be in group A and another 10 patients will be in group B.
Group A: WLE followed by AFI followed by NBI followed by pCLE. Group B: WLE followed by NBI followed by AFI followed by pCLE.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A: WLE followed by AFI followed by NBI followed by pCLE. Receives: Procedure: Gastroscopy |
| Group B | Active comparator | Group B: WLE followed by NBI followed by AFI followed by pCLE. Receives: Procedure: Gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of accurate endoscopic diagnosis made with pCLE compared with histopathology diagnosis
For each patient, the minimum sites of pCLE examination must consist of 2 sites at antrum, 1 site at the incisura, 2 sites at the corpus, and 1 site at the cardia. When suspicious lesions are present, more sites of pCLE examination will be allowed. Each site of pCLE examination will be biopsied and sent for histology.The pCLE examination will be video recorded and interpretation will be done independently on a separate day from the endoscopy day.The analysis will be by per biopsy site matched with corresponding video sequence
Measured: An average of 1 week for which histology report will be out for comparison
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Intestinal MetaplasiaStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Khek Yu Ho, Prof, Principal investigator, NUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398579
- Sponsor's protocol ID
- E\10\703
- Acronym
- pCLE-GCEP
- Status last verified
- Aug 2011
- First submitted
- 26 Jun 2011
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Uedo N, Ishihara R, Iishi H, Yamamoto S, Yamamoto S, Yamada T, Imanaka K, Takeuchi Y, Higashino K, Ishiguro S, Tatsuta M. A new method of diagnosing gastric intestinal metaplasia: narrow-band imaging with magnifying endoscopy. Endoscopy. 2006 Aug;38(8):819-24. doi: 10.1055/s-2006-944632.
PubMed 17001572Eisen GM, Baron TH, Dominitz JA, Faigel DO, Goldstein JL, Johanson JF, Mallery JS, Raddawi HM, Vargo JJ 2nd, Waring JP, Fanelli RD, Wheeler-Harbough J; American Society for Gastrointestinal Endoscopy. Complications of upper GI endoscopy. Gastrointest Endosc. 2002 Jun;55(7):784-93. doi: 10.1016/s0016-5107(02)70404-5.
PubMed 12024128Pohl H, Rosch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28.
PubMed 18755886Buchner AM, Shahid MW, Heckman MG, Krishna M, Ghabril M, Hasan M, Crook JE, Gomez V, Raimondo M, Woodward T, Wolfsen HC, Wallace MB. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology. 2010 Mar;138(3):834-42. doi: 10.1053/j.gastro.2009.10.053. Epub 2009 Nov 10.
PubMed 19909747Inoue T, Uedo N, Ishihara R, Kawaguchi T, Kawada N, Chatani R, Kizu T, Tamai C, Takeuchi Y, Higashino K, Iishi H, Tatsuta M, Tomita Y, Toth E. Autofluorescence imaging videoendoscopy in the diagnosis of chronic atrophic fundal gastritis. J Gastroenterol. 2010;45(1):45-51. doi: 10.1007/s00535-009-0150-7. Epub 2009 Oct 30.
PubMed 19876586Kato M, Kaise M, Yonezawa J, Yoshida Y, Tajiri H. Autofluorescence endoscopy versus conventional white light endoscopy for the detection of superficial gastric neoplasia: a prospective comparative study. Endoscopy. 2007 Nov;39(11):937-41. doi: 10.1055/s-2007-966857.
PubMed 18008201Ezoe Y, Muto M, Horimatsu T, Minashi K, Yano T, Sano Y, Chiba T, Ohtsu A. Magnifying narrow-band imaging versus magnifying white-light imaging for the differential diagnosis of gastric small depressive lesions: a prospective study. Gastrointest Endosc. 2010 Mar;71(3):477-84. doi: 10.1016/j.gie.2009.10.036.
PubMed 20189506Yao K, Iwashita A, Tanabe H, Nishimata N, Nagahama T, Maki S, Takaki Y, Hirai F, Hisabe T, Nishimura T, Matsui T. White opaque substance within superficial elevated gastric neoplasia as visualized by magnification endoscopy with narrow-band imaging: a new optical sign for differentiating between adenoma and carcinoma. Gastrointest Endosc. 2008 Sep;68(3):574-80. doi: 10.1016/j.gie.2008.04.011. Epub 2008 Jul 26.
PubMed 18656862Kato M, Kaise M, Yonezawa J, Goda K, Toyoizumi H, Yoshimura N, Yoshida Y, Kawamura M, Tajiri H. Trimodal imaging endoscopy may improve diagnostic accuracy of early gastric neoplasia: a feasibility study. Gastrointest Endosc. 2009 Nov;70(5):899-906. doi: 10.1016/j.gie.2009.03.1171.
PubMed 19595318Wallace MB, Meining A, Canto MI, Fockens P, Miehlke S, Roesch T, Lightdale CJ, Pohl H, Carr-Locke D, Lohr M, Coron E, Filoche B, Giovannini M, Moreau J, Schmidt C, Kiesslich R. The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract. Aliment Pharmacol Ther. 2010 Mar;31(5):548-52. doi: 10.1111/j.1365-2036.2009.04207.x. Epub 2009 Nov 30.
PubMed 20002025Lim LG, Yeoh KG, Srivastava S, Chan YH, Teh M, Ho KY. Comparison of probe-based confocal endomicroscopy with virtual chromoendoscopy and white-light endoscopy for diagnosis of gastric intestinal metaplasia. Surg Endosc. 2013 Dec;27(12):4649-55. doi: 10.1007/s00464-013-3098-x. Epub 2013 Jul 27.
PubMed 23892761
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison Between Probe-based Confocal Laser Endomicroscopy, White-light Endoscopy and Virtual Chromoendoscopy for the Diagnosis of Gastric Pre-neoplastic and Neoplastic Lesions (pCLE-GCEP)
- ClinicalTrials.gov ID
- NCT01398579
- Acronym / sponsor ID
- pCLE-GCEP / E\10\703
- Conditions
- Intestinal Metaplasia, Intestinal Dysplasia
- Keywords
- intestinal metaplasia, dysplasia, probe-based confocal endomicroscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 20 Jul 2011 (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.
The investigators hypothesis that
- clinical applicability and overall diagnostic sensitivity and specificity of pCLE for diagnosing gastric preneoplastic and neoplastic lesions is acceptable
- pCLE, as compared to white-light endoscopy (WLE), AFI and magnifying NBI has higher sensitivity and specificity for the diagnosing gastric pre-neoplastic and neoplastic lesions
Detailed description
Patients will be recruited from an ongoing study - Gastric Cancer Epidemiology, Clinical and Genetic Programme Cohort Study (GCEP). GCEP is a prospective cohort study aiming to enroll 3,000 Singapore- Chinese subjects aged >50 years, and offers screening by endoscopy and systematic follow-up for a minimum of 5 years. 20 patients will be randomized into two groups. All of them will be examined using four different endoscopy imaging technologies by one trained specialist. 10 patients will be in group A and another 10 patients will be in group B. Group A: WLE followed by AFI followed by NBI followed by pCLE. Group B: WLE followed by NBI followed by AFI followed by pCLE. The difference between two groups is the sequence of two endoscopy imaging modes - AFI and NBI. Diagnosis made during NBI and AFI must be made based on pre-defined criteria, and should not be influenced by the preceding imaging modality. To control for the possible bias on the third imaging modality caused by influence from the preceding imaging modality, patients are randomized to receive NBI before AFI or AFI before NBI.
Endoscopic diagnosis will be made for each suspected lesion with every imaging modality. The biopsy of lesions will be taken after pCLE examination is completed and sent for histology. In the absence of suspicious lesions, the area of examination will be as follows (as stated in main GCEP protocol):
- A1- lesser curvature of the antrum, within 2-3cm of the pylorus.
- A2- greater curvature of the antrum, within 2-3cm of the pylorus.
- IA- incisura angularis.
- B1- lesser curvature of the corpus, 4cm proximal to the angulus.
- B2- middle portion of the greater curvature of the corpus, 8cm from the cardia.
- Cardia (C) - within 1 cm below the OGJ (defined as the point where gastric folds disappear).
The results will be compared with the gold standard diagnosis - histopathology diagnosis. The sensitivity and specificity for each imaging tool will be calculated accordingly.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: GastroscopyGroup A: WLE followed by AFI followed by NBI followed by pCLE. |
| Group B | Active comparator | Procedure: GastroscopyGroup B: WLE followed by NBI followed by AFI followed by pCLE. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject is Chinese
- The subject is greater than 50 years of age
- The subject satisfies one or more of the following criteria:
- Has past history of intestinal metaplasia or dysplasia
- The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
Key exclusion criteria (8 listed)
- patients who cannot undergo gastroscopies
- have a personal history of stomach cancer or surgery
- any disabling illnesses
- are pregnant or breast-feeding
- have bronchial asthma or a known allergy to fluorescein
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 |
|---|---|---|
| GastroscopyAlso: OGD20 patients will be randomized into two groups. All of them will be examined using four different endoscopy imaging technologies by one trained specialist. 10 patients will be in group A and another 10 patients will be in group B. Group A: WLE followed by AFI followed by NBI followed by pCLE. Group B: WLE followed by NBI followed by AFI followed by pCLE. | Procedure or surgery | Group A, Group B |
Primary outcome
Percentage of accurate endoscopic diagnosis made with pCLE compared with histopathology diagnosis
Time frame: An average of 1 week for which histology report will be out for comparison
For each patient, the minimum sites of pCLE examination must consist of 2 sites at antrum, 1 site at the incisura, 2 sites at the corpus, and 1 site at the cardia. When suspicious lesions are present, more sites of pCLE examination will be allowed. Each site of pCLE examination will be biopsied and sent for histology.The pCLE examination will be video recorded and interpretation will be done independently on a separate day from the endoscopy day.The analysis will be by per biopsy site matched with corresponding video sequence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
- Background: PubMed 17001572Uedo N, Ishihara R, Iishi H, Yamamoto S, Yamamoto S, Yamada T, Imanaka K, Takeuchi Y, Higashino K, Ishiguro S, Tatsuta M. A new method of diagnosing gastric intestinal metaplasia: narrow-band imaging with magnifying endoscopy. Endoscopy. 2006 Aug;38(8):819-24. doi: 10.1055/s-2006-944632.
- Background: PubMed 12024128Eisen GM, Baron TH, Dominitz JA, Faigel DO, Goldstein JL, Johanson JF, Mallery JS, Raddawi HM, Vargo JJ 2nd, Waring JP, Fanelli RD, Wheeler-Harbough J; American Society for Gastrointestinal Endoscopy. Complications of upper GI endoscopy. Gastrointest Endosc. 2002 Jun;55(7):784-93. doi: 10.1016/s0016-5107(02)70404-5.
- Results publication: PubMed 18755886Pohl H, Rosch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28.
- Results publication: PubMed 19909747Buchner AM, Shahid MW, Heckman MG, Krishna M, Ghabril M, Hasan M, Crook JE, Gomez V, Raimondo M, Woodward T, Wolfsen HC, Wallace MB. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology. 2010 Mar;138(3):834-42. doi: 10.1053/j.gastro.2009.10.053. Epub 2009 Nov 10.
- Results publication: PubMed 19876586Inoue T, Uedo N, Ishihara R, Kawaguchi T, Kawada N, Chatani R, Kizu T, Tamai C, Takeuchi Y, Higashino K, Iishi H, Tatsuta M, Tomita Y, Toth E. Autofluorescence imaging videoendoscopy in the diagnosis of chronic atrophic fundal gastritis. J Gastroenterol. 2010;45(1):45-51. doi: 10.1007/s00535-009-0150-7. Epub 2009 Oct 30.
- Results publication: PubMed 18008201Kato M, Kaise M, Yonezawa J, Yoshida Y, Tajiri H. Autofluorescence endoscopy versus conventional white light endoscopy for the detection of superficial gastric neoplasia: a prospective comparative study. Endoscopy. 2007 Nov;39(11):937-41. doi: 10.1055/s-2007-966857.
- Results publication: PubMed 20189506Ezoe Y, Muto M, Horimatsu T, Minashi K, Yano T, Sano Y, Chiba T, Ohtsu A. Magnifying narrow-band imaging versus magnifying white-light imaging for the differential diagnosis of gastric small depressive lesions: a prospective study. Gastrointest Endosc. 2010 Mar;71(3):477-84. doi: 10.1016/j.gie.2009.10.036.
- Results publication: PubMed 18656862Yao K, Iwashita A, Tanabe H, Nishimata N, Nagahama T, Maki S, Takaki Y, Hirai F, Hisabe T, Nishimura T, Matsui T. White opaque substance within superficial elevated gastric neoplasia as visualized by magnification endoscopy with narrow-band imaging: a new optical sign for differentiating between adenoma and carcinoma. Gastrointest Endosc. 2008 Sep;68(3):574-80. doi: 10.1016/j.gie.2008.04.011. Epub 2008 Jul 26.
- Results publication: PubMed 19595318Kato M, Kaise M, Yonezawa J, Goda K, Toyoizumi H, Yoshimura N, Yoshida Y, Kawamura M, Tajiri H. Trimodal imaging endoscopy may improve diagnostic accuracy of early gastric neoplasia: a feasibility study. Gastrointest Endosc. 2009 Nov;70(5):899-906. doi: 10.1016/j.gie.2009.03.1171.
- Results publication: PubMed 20002025Wallace MB, Meining A, Canto MI, Fockens P, Miehlke S, Roesch T, Lightdale CJ, Pohl H, Carr-Locke D, Lohr M, Coron E, Filoche B, Giovannini M, Moreau J, Schmidt C, Kiesslich R. The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract. Aliment Pharmacol Ther. 2010 Mar;31(5):548-52. doi: 10.1111/j.1365-2036.2009.04207.x. Epub 2009 Nov 30.
- Derived from this study: PubMed 23892761Lim LG, Yeoh KG, Srivastava S, Chan YH, Teh M, Ho KY. Comparison of probe-based confocal endomicroscopy with virtual chromoendoscopy and white-light endoscopy for diagnosis of gastric intestinal metaplasia. Surg Endosc. 2013 Dec;27(12):4649-55. doi: 10.1007/s00464-013-3098-x. Epub 2013 Jul 27.
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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.
Khek Yu Ho, Prof principal investigator
NUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gastroscopy in people with Intestinal Metaplasia and Intestinal Dysplasia, run by National University Hospital, Singapore at 1 site in Singapore.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 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 Singapore. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee Guan Lim (67795555, lee_guan_lim@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of accurate endoscopic diagnosis made with pCLE compared with histopathology diagnosis (time frame: An average of 1 week for which histology report will be out for comparison). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398579, which also lists 11 linked publications.
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 12 Jul 2012.