International PSC Study Group meetingOslo, 14th – 15th June 2010

International PSC database – parameter consensus

Kirsten Muri Boberg, OsloTobias Weismüller, Hannover

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International PSC database: Agenda• Purpose• Type/structure of database (3min-Talk of C. Ponsioen and of C. Bowlus)

• Organization of database• Responsibilities• Legal aspects/personal data protection• Costs• Parameters (3min-Talk of C. Schramm)

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International PSC database: Purpose• Provide key data for international collaborations

– Identification of specific subgroups for further studies • CCA, small-duct etc.

– DNA collections and genetic studies– Epidemiologic studies– Identification of clinical risk factors– Other?

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International PSC database: PurposeDiscussion

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International PSC database: Type & Structure• Should be constructed for robustness, durability and

flexibility– Upgrading should be possible– Avoid solutions like Access

• Accessable to all centers– One database, but automatic access only to own data (password)– Terminal server or web-based– Technology for access to the database must be available at each

center• Experiences?

– Local databases– German HEPNET-database– Nordic Liver Transplant Registry– Others?

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International PSC database: Type & Structure

3 min Talk of C. Ponsioen:

Dataset of the Epi PSC/PBC study

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International PSC database: Type & Structure

3 min Talk of C. Bowlus:

Online PSC-research network application

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International PSC database: Type & Structure

Discussion

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International PSC database: Organisation• Where will the database be located?• Link to local databases and biomaterials?

– (ID-number, see later)

• Who decides which data will be included?– Agreement on some data during this meeting– Additional suggestions can be co-ordinated and sent out

for a vote (accept if ≥50% agree?)

• Who decides on data access for specific projects?

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International PSC database: Organisation

INTERNATIONALDATABASE

A B C D E

Local databaseContact person

A

Local databaseContact person

D

Local databaseContact person

E

Local databaseContact person

C

Local databaseContact person

B

Centre A/B/C/D/E or PSC Study Group suggests a project to all centres

Centres that agree, participate

After approval from centre A/B/C/D, the centre taking the initiative to a study must contact the database co-ordinator to obtain the data

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International PSC database: Responsibilities• Co-ordination and follow-up

– Located to one center – Co-ordinator has access to all data– Access from all centers to own data only

• Responsibility for completeness and update– Each center

• Responsibility for the whole database– Steering committee?

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International PSC database: Organisation and Responsibilities

Discussion

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International PSC database: Legal aspects• Legal aspects must be cleared by each center

– Patients`consent– Ethical committee– Data processing

• Personal data protection– Identity of patient only known to the recruiting centre– Identification through an individual ID-Number (centre-code + patient code) (what is allowed?)– Secure internet connection

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International PSC database: Legal aspects

Discussion

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International PSC database: Costs• Non-recurring costs

– Development of database– Hardware (server, computer)

• Current costs– IT-technician– Study nurse– Co-ordinator

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International PSC database: Costs

Discussion

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International PSC database: Parameters• Aim for completeness of the parameters selected• Focus on a limited number (30? 40? 50?)• Local extensions or connections to other databases

should be the responsibility of each center

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• Liver disease– Date first symptom– Date first biochemical abn.– Date diagnosis liver disease– Cholangiographical findings– Type of cholangiography– Malignancy (CCA, HCC etc)– Date diagnosis malignancy– Revised diagnosis liver– Date revised diagnosis

• IBD– Date first symptom– Date diagnosis IBD– Type of IBD– Date colectomy– Cause of colectomy– Malignancy– Date diagnosis malignancy

• Endpoints– Date OLT 1, 2, 3– Date of death– Cause of death

• Hepatitis serology• Smoking (at time of diagn.)• Alcohol (at time of diagn.)• Other autoimmune disorder in

the patient• Gall stone

• Comments

Main parameters in the Norwegian PSC biobank database

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• Liver disease– Date first symptom– Date first biochemical abn.– Date diagnosis liver disease– Cholangiographical findings– Type of cholangiography– Malignancy (CCA, HCC etc)– Date diagnosis malignancy– Revised diagnosis liver– Date revised diagnosis

• IBD– Date first symptom– Date diagnosis IBD– Type of IBD– Date colectomy– Cause of colectomy– Malignancy– Date diagnosis malignancy

• Endpoints– Date OLT 1, 2, 3– Date of death– Cause of death

• Hepatitis serology• Smoking (at time of diagn.)• Alcohol (at time of diagn.)• Other autoimmune disorder in

the patient• Gall stone

• Comments

Parameters: further discussion

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International PSC database: Type & Structure

3 min Talk of C. Schramm:

additional parameters: pregnancy in PSC

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International PSC database: Parameters• Liver disease

– Date first symptom– Date first biochemical abn.– Date diagnosis liver disease– Cholangiographical findings– Type of cholangiography– Malignancy (CCA, HCC etc)– Date diagnosis malignancy– Revised diagnosis liver– Date revised diagnosis

• IBD– Date first symptom– Date diagnosis IBD– Type of IBD– Date colectomy– Cause of colectomy– Malignancy– Date diagnosis malignancy

• Endpoints– Date OLT 1, 2, 3– Date of death– Cause of death

• Hepatitis serology• Smoking (at time of diagn.)• Alcohol (at time of diagn.)• Other autoimmune disorder in

the patient• Gall stone

• Comments

Discussion

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• Main diagnosis liver disease– PSC– Small duct PSC– PSC/AIH ”overlap”– IgG4

• Date diagnosis liver disease– PSC: date first cholangiography

compatible with PSC– Small duct PSC: date when

collective findings give this conclusion (biopsy, cholangiography)

• Findings at cholangiography– Normal– IH + EH-PSC– IH-PSC (without EH-PSC)– EH-PSC (without IH-PSC)

• Hepatobiliary malignancy (confirmed by histology or cytology)

– None– CCA– CCA in situ (BilIN3) (in explanted

liver)– Gallbladder carcinoma– HCC– Pancreatic carcinoma– Other cancer in the liver region

(not classified within the above groups)

– Unknown

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• Date diagnosis IBD– Date colonoscopy with

macroscopic and/or microscopic findings compatible with IBD

• Type of IBD– None– UC– CD– IBD unclassified– Unknown

• Extension of IBD (macro/micro)– Left-sided (distal of left flexure)– Right-sided (prox. of left flexure)– Total colitis– Proctitis– Pouchitis

• Cause of colectomy– Active disease– Dysplasia (low-grade)– Dysplasia (high-grade/ca. in situ)– DALM (dysplasia associated

lesion or mass)– Colon carcinoma

• Malignancy, bowel– None– Dysplasia (low-grade)– Dysplasia (high-grade/ca. in situ)– DALM– Carcinoma– Unknown

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• Date OLT (no. 1, 2, 3..)• Recurrence after OLT

• Date of death

• Cause of death– Liver failure– Hepatopancreaticobiliary cancer – Colon cancer– Other cancer– Other cause

• Smoking history (recorded at time of diagnosis liver disease)

– Yes – current smoker (regular use)

– Ex-smoker– Never smoker– Unknown

• Alcohol (recorded at time of diagnosis liver disease) (units/d)

– 0 – 1– >1 – 3– >3– Unknown

• Autoimmune disease in patient– DM type 1– Thyroid disease– Coeliac disease– Reumatoid arthritis– Sarcoidosis– Psoriatic disease– Nephritis– Vitiligo– SLE– Vasculitis– Fibrosing alveolitis– Sacroileitis