IcterusNCT00295360
Expression of BCRP in Icteric Patients
An observational study of Icterus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The expression of transporters involved in bile acid homeostasis is differentially regulated during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter breast cancer resistance protein (BCRP) that is highly expressed in the human intestine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Icterus
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2003to Aug 2004
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of obstructive cholestasis (obstructive jaundice was defined on the basis of chemical parameters (bilirubin, g-glutamyltransferase, and alkaline phosphatase) and on imaging procedures (ultrasound and ERCP) demonstrating a dilated bile duct system)
- control subjects had an indication for a gastrointestinal tract endoscopy within a cancer-screening program
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Basel, Department of Research
Basel, Canton of Basel-City, 4031
About this study
Official title: Influence of Cholestasis on Intestinal BCRP Expression
The expression of transporters involved in bile acid homeostasis is differentially regulated during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter breast cancer resistance protein (BCRP) that is highly expressed in the human intestine. Therefore we intend to analyze whether intestinal BCRP expression could be altered during cholestasis.
Read the detailed description
BCRP is capable of transport bile acids and may indicate that this transporter is involved in bile acid homeostasis. As an efflux pump, it could protect the enterocytes from potential toxic bile acid concentrations. During cholestasis, where the enterohepatic circulation is disrupted, there occurs an adaptive regulation of transporters for bile acids, bilirubin and cholesterol. These changes take place in liver, kidney, as well as in the intestine.
Using real-time RT-PCR analysis we determine BCRP mRNA expression levels in duodenal tissue of healthy subjects and cholestatic patients. BCRP protein levels will be determined by immunohistochemistry.
Healthy subjects and cholestatic patients are enrolled in the study after giving informed consent. Control subjects with an indication for a gastrointestinal tract endoscopy within a cancer-screening program and patients with obstructive cholestasis with an interventional endoscopic retrograde cholangiopancreatography (ERCP) are included in this study. During endoscopy four biopsy specimens are obtained from the distal part of the duodenum. Biopsies are immediately stored at -70°C until further processing.
- Conditions
- Icterus
- Being tested
- no intervention, pathophysiological study
- Keywords
- cholestasis, BCRP, multidrug resistance, duodenum, bile acids, ABCG2
- Medical subject headings
- Jaundice, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, pathophysiological studyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startJun 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IcterusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Jürgen Drewe, MD, MSc, Principal investigator, Department of Clinical Pharmacology, University Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295360
- Sponsor's protocol ID
- MDR-108-03
- Status last verified
- Mar 2005
- First submitted
- 17 Feb 2006
- Last updated
- 23 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cholestasis on Intestinal BCRP Expression
- ClinicalTrials.gov ID
- NCT00295360
- Acronym / sponsor ID
- MDR-108-03
- Conditions
- Icterus
- Keywords
- cholestasis, BCRP, multidrug resistance, duodenum, bile acids, ABCG2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2003
- Study completion
- Aug 2004
- First posted
- 23 Feb 2006 (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 expression of transporters involved in bile acid homeostasis is differentially regulated during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter breast cancer resistance protein (BCRP) that is highly expressed in the human intestine. Therefore we intend to analyze whether intestinal BCRP expression could be altered during cholestasis.
Detailed description
BCRP is capable of transport bile acids and may indicate that this transporter is involved in bile acid homeostasis. As an efflux pump, it could protect the enterocytes from potential toxic bile acid concentrations. During cholestasis, where the enterohepatic circulation is disrupted, there occurs an adaptive regulation of transporters for bile acids, bilirubin and cholesterol. These changes take place in liver, kidney, as well as in the intestine.
Using real-time RT-PCR analysis we determine BCRP mRNA expression levels in duodenal tissue of healthy subjects and cholestatic patients. BCRP protein levels will be determined by immunohistochemistry.
Healthy subjects and cholestatic patients are enrolled in the study after giving informed consent. Control subjects with an indication for a gastrointestinal tract endoscopy within a cancer-screening program and patients with obstructive cholestasis with an interventional endoscopic retrograde cholangiopancreatography (ERCP) are included in this study. During endoscopy four biopsy specimens are obtained from the distal part of the duodenum. Biopsies are immediately stored at -70°C until further processing.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of obstructive cholestasis (obstructive jaundice was defined on the basis of chemical parameters (bilirubin, g-glutamyltransferase, and alkaline phosphatase) and on imaging procedures (ultrasound and ERCP) demonstrating a dilated bile duct system)
- control subjects had an indication for a gastrointestinal tract endoscopy within a cancer-screening program
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| no intervention, pathophysiological study | Behavioural | – |
Primary outcome
Not reported in the source record.
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 23 Feb 2006.
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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.
Jürgen Drewe, MD, MSc principal investigator
Department of Clinical Pharmacology, University Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Icterus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 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 23 Feb 2006. 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 Switzerland. 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.
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 23 Feb 2006.