Barrett's Esophagus Clinical Trial
Official title:
The Renin-angiotensin System (RAS) in Barrett's Esophagus as Future Biomarkers for Dysplasia and Cancer? A Randomized Controlled Trial
Verified date | August 2016 |
Source | Göteborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
Barrett`s esophagus (BE) is the major esophageal pre-neoplastic lesion in which dysplastic
transformations eventually can lead to cancer development. Today, the only way for early
detection of pre-neoplastic lesions is an endoscopic surveillance programme with tissue
sampling for histopathology, the latter being the only validated biomarker for esophageal
adenocarcinoma (EAC)-risk available. New biomarkers are warranted for better patient
selection before inclusion into BE surveillance programmes.
Epidemiologic studies have demonstrated suppressed numbers of cancer prevalence in cohorts
being under different medical treatment. In a British epidemiological study 2007 Sjöberg et
al noted a lower prevalence of EAC among patients treated with antihypertensive drugs
interfering with the renin-angiotensin system (RAS) such as AT1R-blockers and
ACE-inhibitors. The last decade this endocrine signalling system has been proven to be
involved in pathological conditions such as inflammation, wound-healing and even cancer, in
several organ systems.
Earlier reports from the investigators laboratory indicate the existence of a local RAS in
the esophageal wall musculature and in the squamous mucosa. In the investigators latest
explorative study, the investigators discovered the altered expression of "classical" RAS
components in BE with and without dysplasia (unpublished results).
By a possible alteration in RAS-related protein-expression in BE with increasing grade of
dysplasia towards EAC, the investigator may have a possible "pathway" leading to biomarkers
for cancer-development. Furthermore, the already well-known anti-hypertensive drugs
ACE-inhibitors and AT1R-blockers may interfere with the risk of malignancy in BE. The
investigators therefore wish to test, in an exploratory prospective randomized
placebo-controlled setting, whether RAS-related protein-expressions in BE are altered by the
addition of RAS-suppressant pharmaceuticals. In the same manner the investigators wish to
see if the expressions of well-known biomarkers for cancer and inflammation are altered.
Status | Completed |
Enrollment | 33 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Barretts esophagus with a minimum length of 1 cm and histomorphologically confirmed low grade dysplasia Exclusion Criteria: - Treatment with ACE-inhibitors (angiotensin converting enzyme inhibitors) or AT1R-antagonists (angiotensin type 1 receptor antagonists). Newly diagnosed or treatment resistant hypertonia or renal failure. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Sweden | Dept. of Gastrosurgical Research and Education, Inst. Clinical Sciences, Sahlgrenska University Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Göteborg University | Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in expression of proteins associated with inflammation, proliferation and cancer development | Change in expression of p53, AMACR, Caspase 3, iNOS, VEGFR2, EGFR, CyclinD1, NFkB, PPARy, Cox-2, NLRP3 and MPO after 3 weeks treatment, assessed by Western blot. | Assessed at baseline (day 0) and after three weeks (day 21) of treatment | No |
Secondary | Change in regulation of potential new biomarkers associated with esophageal cancer | Change in regulation after 3 weeks treatment of proteins associated with esophageal cancer assessed by global proteomic analysis. Expression of regulated proteins found in the proteomic analysis are further investigated with Western blot. | Assessed at baseline (day 0) and after three weeks (day 21) of treatment | No |
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