Letter of Intent for Tissue Microarrays

To receive tissue from the resource, you must first send a Letter of Intent (LOI) that contains:

1. Your name, surface mail and email address, and telephone number
   
   
2. Scientific rationale: This section of the LOI (usually one page in length) should include the following:
   1. Concise introduction to the project concluding with a brief statement of the hypothesis of the proposed research.
   2. Specific aims of the work to be carried out with the TMAs.
   3. Information about the marker(s) to be evaluated - briefly describe each marker and why it was selected for testing including:
      1. Evidence that the marker(s) is relevant to this cancer - describe preliminary data and cite published references suggesting the importance of each marker.
      2. If more than one marker will be included in the analysis, describe how the markers are related to each other.
   
   
3. Technical approach: This section of the LOI (usually about one page in length) should include the following:
   1. A brief description of the technical approach, the measurement technique(s) and reagent(s)
   2. Evidence that the specific techniques and reagents have been used in paraffin-embedded sections and that your lab can successfully perform these assays. (We can provide test sections to optimize assay conditions.) Preferred evidence is photographs or figures generated in your own laboratory that are annotated with legends describing what tissues were assayed and what marker results (e.g., staining intensity) are exhibited.
   3. A description of the scoring system. For example, if results will be reported as "positive" or "negative," how will these be defined? What is the basis (preliminary data) for using this scoring system?
   4. Positive and negative controls to be used.
   
   
4. Statistical plan: This section of the LOI (usually about 0.5 page in length) should describe how the assay results obtained using the TMA will be analyzed and should include:
   1. In what form will the data be used in the analysis?
      
      Examples:
      · Binary assessments of marker positive/negative status
      · Categorical scale such as 0, 1+, 2+, 3+
      · Continuous measurements such as percent stained cells or output from a quantitative image analysis system
      
      
   2. A brief description of the statistical approach that will be used to test the hypothesis you stated above.
      
      Examples:
      · Chi-square test or Fisher exact test to test for differences in marker positivity rates between groups
      · T-tests to test for differences in mean marker levels between groups
      · Log-rank test or Cox proportional hazards regression to test for associations between marker and recurrence or survival times
      
      
   3. Study design considerations.
      1. These arrays were statistically designed to have good power to compare marker prevalence across groups defined by stage or outcome (e.g, 80% power to detect an absolute difference in positivity rate for a binary marker of about 0.30 (30%) between stage I and stage IV disease).
      2. Please indicate that the Statistical Guidance for the Array was read.
      3. The REP highly recommends that you obtain the assistance of a statistician if you plan to conduct statistical analyses more complex than simple comparisons of categorical marker values.
   
   
5. Type of Tissue Microarray Requested (e.g., Colon TMA)
   
   
6. Statement of the number of TMA slides you are requesting
   
   Please keep in mind that on any one TMA slide there is one core per tumor or non-tumor tissue. For the Colon tissue microarrays, there are 478 tissue specimens (along with controls) that are split into four separate TMA slides. Hence, four TMA slides are required to obtain measurements for all of the 478 tissue specimens. To account for biological heterogeneity within a specimen, the REP recommends that TMA slides be assayed in duplicate. Therefore, the typical Colon TMA request would be for eight slides. See http://cdp.nci.nih.gov/colon_tma.html for a more complete description of the Colon TMA design.
   
   
7. A Brief Biosketch (Please send as an attachment)

Please submit your Letter of Intent electronically.

You may mail your LOI and relevant attachments to:

Cindy Mattingly
Information Management Services, Inc.
12501 Prosperity Drive, Suite 200
Silver Spring, MD 20904
tissueresources@imsweb.com

If you choose to mail your LOI please be sure to send it in the same format as the electronic form and include all the required information. Incomplete LOIs will be returned for completion resulting in a delay in the evaluation and review of your request.