For researchers

You can apply for the use of samples and data from Janus Serum Bank for cancer research. The biological material has been used in research since the 1980s, and is used by researchers both nationally and internationally. The research must be within Janus Serum Bank's purpose, and all use of data and biological material is subject to Norwegian legislation.
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To get access to the material from Janus Serum Bank, you must fill out an electronic application form and attach necessary documentation. Applications to the Janus Serum Bank are processed by Janus' steering committee every six months.

The next application deadline is February 15, 2024.

On this page you will find information about: 

  1. The material
  2. Terms of use
  3. Prices 
  4. The application process
  5. Application approval
  6. Data delivery

 

1. The material

The most widely used study design in the Janus biobank is the nested case-control design that selects controls from the same source population as for the cases.

The controls are selected from the Janus cohort members who are still disease-free at the time a case occurs. The cases are identified by linking the personal identification number in the biobank to the cancer registry. For each case, a specified number of matched controls are selected randomly among all those eligible at the time of the diagnosis of the case.

Matching of case and control is usually at an individual level and common matching criteria are gender, age, county, storage time and cohort. The matching of cases and controls according to time of blood draw, is recommended in order to minimize the impact of preanalytical handling, storage, and lifestyle effects. The Janus cohort represents the general population but also contains a subgroup of red Cross blood donors, that are a selected group of the population (e.g. they have been selected to not have any blood-borne diseases).We therefore recommend matching population-based cases to population-based controls, and blood donor cases to blood donor controls.

In a biobank, there will always be a trade-off between the need for saving biological material from rare cases for future use, and the need to match controls from the entire cohort to avoid selection bias. We assume that when the access to eligible controls is almost unlimited for a project, the selection bias will be negligible.

 

The table shows a proposed list of selection criteria in Janus projects.

Item

Spesification

 

 

 

Criteria for being a case

  • All cancers of specific site according to criteria developed by the Cancer Registry
  • Specific time period
  • Allow melanoma skin cancer prior to diagnosis 
  • Blood draw minimum one month before diagnosis to ensure that blood draw was made prior to treatment and to minimize biochemical effects caused by a soon-to-be-diagnosed cancer

 

 

 

Criteria for being a control

  • Alive and resident in Norway at date of diagnosis of case (ensuring follow-up for the same length of time as the case)
  • Free of cancer at the time of diagnosis of the case except for non-melanoma skin cancer (should be the same exclusion criteria used as for the cases).
  • Allow common cancers after date of diagnosis of case, but exclude controls with rare cancers to conserve valuable samples for later studies

 

 

Matching criteria

  • Age at blood draw typically differ no more than +/- 1 year from age of case at blood draw
  • Date of blood draw typically differ no more than +/- 3 months from data of blood draw of case
  • Same sex as case.
  • Blood draw in same county

 

 

Quality assurance in biobanking involves all phases from sampling to publishing scientific results.

Janus Serum Bank has established its own quality manual which contains all necessary procedures and routines, including handling of samples, storage, analysis methods, data quality and administrative conditions such as sample accessibility for the researchers, scientific evaluation of projects, study design and coding system. Both storage and handling of biological samples are regulated by laws on the protection of privacy, necessitating stringent procedures and routines.

Sample quality

The samples in the Janus serum bank are stored at -25 degrees Celcius, and the oldest samples have been stored for more than 40 years. For measurements of a sample to be of value, we need to know whether it has changed during the time that has passed since it was drawn.

Factors that can affect sample quality:

Sample treatment before freezing

  • bottling
  • coagulation
  • centrifugation
  • transport and time before freezing

Storage effects

  • decomposition
  • oxidation
  • loss of water (sublimation)
  • change of matrix

Component stability

  • knowledge of which components are stable during storage is essential for studies based on the biobank material.

Stability data

The sample quality has been documented through stability studies. Here you can download a table showing stability data for selected serum components.

Bias criterion is based on biological variation, within an individual and between individuals. The percentage difference between fresh and long-term stored samples must not deviate more than the permitted bias if the difference is to be declared as insignificant.

With new technology, the Janus material can be used in genetic studies. For example, we have shown that the miRNA and DNA in the samples are of good enough quality to do sequencing analyses.

Selected publications of quality studies from Janus Serum Bank

  1. Gislefoss RE, Grimsrud TK, Mørkrid L. Long-term stability of serum components in the Janus Serum Bank. Scand J Clin Lab Invest. 2008;68(5):402-9.
    doi: 10.1080/00365510701809235.
    PMID: 18752145.
  2. Ekstrom PO, Bjorge T, Dorum A, Longva AS, Heintz KM, Warren DJ, Hansen S, Gislefoss RE, Hovig E.
    Determination of hereditary mutations in the BRCA1 gene using archived serum samples and capillary electrophoresis.
    Anal Chem 2004; 76(15):4406-4409.
  3. Ulvik A, Vollset SE, Hansen S, Gislefoss R, Jellum E, Ueland PM.
    Colorectal cancer and the methylenetetrahydrofolate reductase 677C -> T and methionine synthase 2756A -> G polymorphisms: a study of 2 168 case-control pairs from the JANUS cohort.
    Cancer Epidemiol Biomarkers Prev 2004; 13(12):2175-2180.
  4. Keller A, Leidinger P, Gislefoss R, Haugen A, Langseth H, Staehler P, Lenhof HP, Meese E.
    Stable serum miRNA profiles as potential tool for non-invasive lung cancer diagnosis.
    RNA Biol 2011; 8(3).

 

2. Terms of use

  • The project manager must have research competence equivalent to PhD level
  • The research projects must be within the purpose of the Janus serum bank. The purpose is described in the Guidelines for management and use of biological material and data from the Janus serum bank
  • Before the biological material or research data can be handed over, the project must be approved by the Regional Committees for Medical and Health Research Ethics (REK)
  • The applicant must demonstrate that the project has a legal basis for processing pursuant to Articles 6 and 9 of the General Data Protection Regulation (GDPR), and that the need for a data protection impact assessment has been assessed pursuant to Article 35 of the GDPR. The disclosure of information and/or biological material to third countries is subject to compliance with the conditions set out in the GDPR.
  • At least one collaborator/co-author from the Cancer Registry of Norway must be appointed.
  • Biological material or research data will not be disclosed until funding has been secured
  • In order to manage the biological material in the best possible way, it is necessary to charge a financial fee for using the samples in research projects.

All research projects involving information and/or biological material from the Janus serum bank require prior ethical approval from the Regional Committee for Medical and Health Research Ethics (REK), and must also have a legal basis for processing pursuant to Articles 6 and 9 of the General Data Protection Regulation (GDPR). The applicant must also have assessed the need for a data protection impact assessment pursuant to Article 35 of the GDPR. The applicant must prove that the requirements are met before data can be made available. Disclosure of information and/or biological material to third countries requires that the conditions of the GDPR are met.   

 

3. Prices

The standard fee is NOK 50.000 (excl. VAT) per project, and covers, among others, the following elements:

  • Processing of serum applications to the Janus Serum Bank
  • Scientific support in setting up the research protocol (study design, criteria for selection of study population)
  • Research administration (application to Regional Ethics Committee, application to the Cancer Registry of Norway’s Data Delivery Unit, and potential other data sources)
  • Costs relating to management of data delivery from the Cancer Registry

The sample fee is a combination of a serum volume dependent price, and labour costs (see table below). Shipment costs are charged separately.

Serum volume

Price incl. labour costs* (excl. VAT)

≤ 100 μl

NOK 200

100-150 μl

NOK 225

151-300 μl

NOK 250

301-400 μl

NOK 300

*Labour costs (sample picking, pipetting and material costs) is per 25.04.2018 estimated to NOK 50,- per sample

The hourly rate for data management is NOK 900 (excl. VAT). The workload is estimated to 30-50 hours per project, depending on the complexity.

Data management includes:

  • Linkages to the Cancer Registry of Norway for identification of study population (selection of specific cancer diagnoses and healthy controls)
  • Linking of project specific covariates
  • Compiling the final research file
  • Quality assurance and documentation

 

4. The application process

The Janus Serum Bank secretariat assists in scientific issues and study design.

The secretariat, consisting of both technicians and researchers, has considerable experience in biobanking and has also an important role in the daily administration of the biobank. Our ambition is to be a reliable consultative body for researchers regarding scientific issues, study design, laboratory analyses and help to improve applications, when necessary.  

To get access to material from Janus Serum Bank, you must fill out the online application form at the Cancer Registry of Norways metadatabase and attach the necessary documentation. Uncompleted application will not be evaluated.

A complete application contains:

  • Completed application form
  • A detailed scientific protocol, containing the background and objectives of the study, method description, description of data flow (data management) and a data analysis plan, justification for desired serum volume and strength calculations, and planned publications
  • CVs of the project manager and other key participants in the project group (maximum four pages)
  • Information about financing the project
  • Approved data protection impact assessment or a reasoned assessment of why this is not necessary. The investigation shall contain a description of the basis for processing pursuant to Articles 6 and 9 of the GDPR
  • If the project manager is from Norway, REK approval must be attached to the grant application

The project manager will receive confirmation of the application received from janus@kreftregisteret.no.

 

 

5. Application approval

The Janus Bank has a multidisciplinary steering committee including 5 members with qualifications on epidemiology, molecular biology, virology, biochemistry and statistics. The steering committee is responsible for the scientific evaluation of the project applications, in order to secure the best use of the material in the Bank.

 

If the application is approved, the applicant will receive an email from the Janus serum bank with the approval. The Cancer Registry of Norway enters into an agreement with the research institution to which the project manager is affiliated, which sets out the conditions for approval.

In the event of partial approval/approval under conditions, the applicant will be asked to rectify or elaborate on the application. This is processed by the steering committee, and the applicant receives an email from the Janus serum bank with a final decision.

 

6. Data delivery

All samples within a research study are given different codes, enabling blinded analyses. This coding system has been routine for several decades in the Janus Serum Bank. The case control status and other information on the cancer diagnosis will first be issued when the laboratory analyses are completed and the results returned to the secretariat.

The Cancer Registry’s Data Delivery Unit links the cancer information and ensures that all necessary documents are available before the de-identified data file is delivered to the researcher. The coding system assures the privacy of the donors and prevents research misconduct.

When the laboratory analyzes are completed, the result must be returned to the Janus Serum Bank secretariat. Contact janus@kreftregisteret.no for information about how data should be returned.