Gastroesophageal Reflux DiseaseEGFRNCT01806220
Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis
A study testing Biopsy of the retrocrycoid laryngeal mucosa and Biopsy of the distal esophageal mucosa in people with Gastroesophageal Reflux Disease and Chronic Laryngitis, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Saliva plays an important role in the homeostasis of the digestive tract mucosa. Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found in defficient concentrations in patients with gastroesophageal reflux disease (GERD) and reflux related laryngitis (LPR). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Chronic Laryngitis
- What is being tested?
- Biopsy of the retrocrycoid laryngeal mucosa and Biopsy of the distal esophageal mucosa
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2004to Dec 2007
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with reflux laryngitis diagnosed by clinical symptoms (Reflux Symptom -Index >13) and videolaryngoscopic signs (Reflux Finding Score >7)
- A positive 24-hour doube probe esophageal ph monitoring test
Who cannot join
- Other known causes of chronic laryngitis or inflammatory conditions of the pharynx, larynx and upper digestive tract.
- Current or past history of Head and Neck or digestive tract tumors.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa School of Medicine and Hospitals of São Paulo Brazil
São Paulo, São Paulo, 01222-010
About this study
- Saliva plays an important role in the homeostasis of the digestive tract mucosa.
- Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found in defficient concentrations in patients with gastroesophageal reflux disease (GERD) and reflux related laryngitis (LPR).
- The epidermal growth factor receptor (EGFR) signaling pathway is one of the most important pathways that regulate growth, survival, proliferation, and differentiation in mammalian cells
- Eperdermal growth factor receptor (EGFR) overexpression has been linked to hyperproliferative diseases.
- It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR expression.
- The objective of the current study was to try to establish a correlation between the expression of EGFR in the laryngeal and esophageal mucosa and the severity of laryngitis in adults with GERD and LPR
Read the detailed description
Objectives: The expression of the Epidermal Growth Factor receptor (EGFR) has been studied in a number of neoplastic and chronic diseases, but there are no reports in literature regarding its expression in chronic laryngitis associated to Gastroesophageal Reflux isease (GERD), also known as Laryngopharyngeal Reflux (LPR). The current study compared the expression of EGFR in the esophageal and laryngeal mucosa of adults with GERD and LPR. Study Design: Prospective based on imunohistochemical analysis of parafine embedded biopsy specimens and clinical data. Methods: From August, 2004 to February 2007 a total of 24 adults with confirmed diagnosis of LPR and no other clinical conditions or habits known to cause chronic laryngitis were studied at a University Hospital. Biopsies of the distal esophagus and the retrocrycoid laryngeal mucosa were obtained during upper digestive endoscopy. Data were analyzed statistically comparing samples in each individual and between individuals using the severity of histological signs of inflammation on hematoxacillin and eosinophillin (HE) stains to immunohistochemical analysis of the expression of EGFR. Other independent variables were severity of symptoms and signs, gender and age. Fishers´s exact test and multivariance ANOVA tests were used with significance level established at 95%.
- Being tested
- Biopsy of the retrocrycoid laryngeal mucosa, Biopsy of the distal esophageal mucosa
- Keywords
- Gastroesophageal Reflux Disease (GERD), Chronic Laryngitis, Epidermal Growth factor receptor
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of the retrocrycoid laryngeal mucosaProcedure or surgery
Biopsies of the retrocrycoid laryngeal mucosa were performeed under sedation using a forceps introduced by the working channel of the endoscope
Biopsy of the distal esophageal mucosaProcedure or surgery
Biopsies were performeed under sedation using a forceps introduced by the working channel of the endoscope during upper digestive endoscopy
| Study group | Role | What they receive |
|---|---|---|
| biopsy of retrocrycoid laryngeal mucosa | Active comparator | During upper digestive endoscopy a biopsy specimen of the retrocrycoid laryngeal mucosa was obtained with a forceps introduced by the working channel of the scope.
Intervention: biopsy of retrocrycoid laryngeal mucosa Receives: Procedure: Biopsy of the retrocrycoid laryngeal mucosa |
| biopsy of distal esophagus mucosa | Active comparator | during upper digestive endoscopy a biopsy specimen of the distal esophageal mucosa was obtained
Intervention:biopsy of distal esophagus mucosa Receives: Procedure: Biopsy of the distal esophageal mucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitis
Patients with reflux laryngitis diagnosed by suggestive symptoms (Reflux Symptom Index>13) and videolaryngoscopic signs (Reflux Finding Score>7) and confirmed by a 24-hour double probe esophageal ph monitoring test were consecutively enrolled properly informed and consented.
Measured: prospective study that enrolled every adult patient with reflux laryngitis and no other causes of chronic laryngeal and pharyngeal inflammation during a 36 month period
Secondary outcomes (1)
Compare Epidermal Growth Factor Receptor expression in different severities of inflammatory responses.
Mucosal biopsy specimens obtained during routine upper digestive tract endocopic examination under sedation were obtained.
Measured: EGFR expression of the esophageal and laryngeal mucosas was compared to clinical, videolaryngoscopic and microscopic inflammatory signs. (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CLAUDIA ALESSANDRA ECKLEY, Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Investigators
- CLAUDIA A ECKLEY, MD, Principal investigator, SANTA CASA SCHOOL OF MEDICINE AND HOSPITALS OF SÃO PAULO BRAZIL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806220
- Sponsor's protocol ID
- fcmscsp180/06
- Acronym
- EGFR
- Status last verified
- Mar 2015
- First submitted
- 29 Aug 2012
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eckley CA, Michelsohn N, Rizzo LV, Tadokoro CE, Costa HO. Salivary epidermal growth factor concentration in adults with reflux laryngitis. Otolaryngol Head Neck Surg. 2004 Oct;131(4):401-6. doi: 10.1016/j.otohns.2004.01.020.
PubMed 15467608Eckley CA, Rios Lda S, Rizzo LV. Salivary egf concentration in adults with reflux chronic laryngitis before and after treatment: preliminary results. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):156-60. doi: 10.1016/s1808-8694(15)31060-0.
PubMed 17589721Sarosiek J, McCallum RW. Do salivary organic components play a protective role in health and disease of the esophageal mucosa? Digestion. 1995;56 Suppl 1:32-7. doi: 10.1159/000201299.
PubMed 7556968Rourk RM, Namiot Z, Edmunds MC, Sarosiek J, Yu Z, McCallum RW. Diminished luminal release of esophageal epidermal growth factor in patients with reflux esophagitis. Am J Gastroenterol. 1994 Aug;89(8):1177-84.
PubMed 8053431
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis
- ClinicalTrials.gov ID
- NCT01806220
- Acronym / sponsor ID
- EGFR / fcmscsp180/06
- Keywords
- Gastroesophageal Reflux Disease (GERD), Chronic Laryngitis, Epidermal Growth factor receptor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Mar 2013 (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.
- Saliva plays an important role in the homeostasis of the digestive tract mucosa.
- Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found in defficient concentrations in patients with gastroesophageal reflux disease (GERD) and reflux related laryngitis (LPR).
- The epidermal growth factor receptor (EGFR) signaling pathway is one of the most important pathways that regulate growth, survival, proliferation, and differentiation in mammalian cells
- Eperdermal growth factor receptor (EGFR) overexpression has been linked to hyperproliferative diseases.
- It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR expression.
- The objective of the current study was to try to establish a correlation between the expression of EGFR in the laryngeal and esophageal mucosa and the severity of laryngitis in adults with GERD and LPR
Detailed description
Objectives: The expression of the Epidermal Growth Factor receptor (EGFR) has been studied in a number of neoplastic and chronic diseases, but there are no reports in literature regarding its expression in chronic laryngitis associated to Gastroesophageal Reflux isease (GERD), also known as Laryngopharyngeal Reflux (LPR). The current study compared the expression of EGFR in the esophageal and laryngeal mucosa of adults with GERD and LPR. Study Design: Prospective based on imunohistochemical analysis of parafine embedded biopsy specimens and clinical data. Methods: From August, 2004 to February 2007 a total of 24 adults with confirmed diagnosis of LPR and no other clinical conditions or habits known to cause chronic laryngitis were studied at a University Hospital. Biopsies of the distal esophagus and the retrocrycoid laryngeal mucosa were obtained during upper digestive endoscopy. Data were analyzed statistically comparing samples in each individual and between individuals using the severity of histological signs of inflammation on hematoxacillin and eosinophillin (HE) stains to immunohistochemical analysis of the expression of EGFR. Other independent variables were severity of symptoms and signs, gender and age. Fishers´s exact test and multivariance ANOVA tests were used with significance level established at 95%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biopsy of retrocrycoid laryngeal mucosa | Active comparator | Procedure: Biopsy of the retrocrycoid laryngeal mucosaDuring upper digestive endoscopy a biopsy specimen of the retrocrycoid laryngeal mucosa was obtained with a forceps introduced by the working channel of the scope. Intervention: biopsy of retrocrycoid laryngeal mucosa |
| biopsy of distal esophagus mucosa | Active comparator | Procedure: Biopsy of the distal esophageal mucosaduring upper digestive endoscopy a biopsy specimen of the distal esophageal mucosa was obtained Intervention:biopsy of distal esophagus mucosa |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with reflux laryngitis diagnosed by clinical symptoms (Reflux Symptom -Index >13) and videolaryngoscopic signs (Reflux Finding Score >7)
- A positive 24-hour doube probe esophageal ph monitoring test
Key exclusion criteria (2 listed)
- Other known causes of chronic laryngitis or inflammatory conditions of the pharynx, larynx and upper digestive tract.
- Current or past history of Head and Neck or digestive tract tumors.
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 |
|---|---|---|
| Biopsy of the retrocrycoid laryngeal mucosaBiopsies of the retrocrycoid laryngeal mucosa were performeed under sedation using a forceps introduced by the working channel of the endoscope | Procedure or surgery | biopsy of retrocrycoid laryngeal mucosa |
| Biopsy of the distal esophageal mucosaBiopsies were performeed under sedation using a forceps introduced by the working channel of the endoscope during upper digestive endoscopy | Procedure or surgery | biopsy of distal esophagus mucosa |
Primary outcome
Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitis
Time frame: prospective study that enrolled every adult patient with reflux laryngitis and no other causes of chronic laryngeal and pharyngeal inflammation during a 36 month period
Patients with reflux laryngitis diagnosed by suggestive symptoms (Reflux Symptom Index>13) and videolaryngoscopic signs (Reflux Finding Score>7) and confirmed by a 24-hour double probe esophageal ph monitoring test were consecutively enrolled properly informed and consented.
1 secondary outcome
Compare Epidermal Growth Factor Receptor expression in different severities of inflammatory responses.
Time frame: EGFR expression of the esophageal and laryngeal mucosas was compared to clinical, videolaryngoscopic and microscopic inflammatory signs. (up to 36 months)
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 20 Mar 2015.
- Background: PubMed 15467608Eckley CA, Michelsohn N, Rizzo LV, Tadokoro CE, Costa HO. Salivary epidermal growth factor concentration in adults with reflux laryngitis. Otolaryngol Head Neck Surg. 2004 Oct;131(4):401-6. doi: 10.1016/j.otohns.2004.01.020.
- Background: PubMed 17589721Eckley CA, Rios Lda S, Rizzo LV. Salivary egf concentration in adults with reflux chronic laryngitis before and after treatment: preliminary results. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):156-60. doi: 10.1016/s1808-8694(15)31060-0.
- Background: PubMed 7556968Sarosiek J, McCallum RW. Do salivary organic components play a protective role in health and disease of the esophageal mucosa? Digestion. 1995;56 Suppl 1:32-7. doi: 10.1159/000201299.
- Background: PubMed 8053431Rourk RM, Namiot Z, Edmunds MC, Sarosiek J, Yu Z, McCallum RW. Diminished luminal release of esophageal epidermal growth factor in patients with reflux esophagitis. Am J Gastroenterol. 1994 Aug;89(8):1177-84.
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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.
CLAUDIA A ECKLEY, MD principal investigator
SANTA CASA SCHOOL OF MEDICINE AND HOSPITALS OF SÃO PAULO BRAZIL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy of the retrocrycoid laryngeal mucosa and Biopsy of the distal esophageal mucosa in people with Gastroesophageal Reflux Disease and Chronic Laryngitis, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 20 Mar 2015. 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 Brazil. 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?
Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitis (time frame: prospective study that enrolled every adult patient with reflux laryngitis and no other causes of chronic laryngeal and pharyngeal inflammation during a 36 month period). 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 NCT01806220, which also lists 4 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 20 Mar 2015.