FOLLOWING ARE ANSWERS TO SOME CONCERNS YOU MAY HAVE WITH REGARD TO THE TUMOR REGISTRY:

Any patient who has contributed their material to the ACC Registry is able to have their material sent from the Registry to any researcher anywhere, anytime. This request will always be honored.

Because of the relative rarity of ACC as a neoplasm (and hence research material), requests from other investigators to the ACC Registry will be critiqued for scientific merit. Preference will be given to peer-reviewed funded investigators and then other academic investigators developing new research projects. A critical component of the research plan should be novelty, and not a mere duplication of existing scientific data. We look forward to sharing tumor material from the ACC Registry to other qualified investigators. A limiting factor might be the amount of material placed into the registry, but valid scientific requests will be honored as much as possible.

In response to the question as to whether you could only send part of a tumor block to the University of VA and retain part for your own use:

Often, there is more than one block for a patient's specimen. We will typically not need all of the blocks for study, and hence only request what is needed. It is possible to melt down blocks and cut tissue out to form other blocks, but this is usually not necessary. The blocks that we receive can all be returned if necessary for patient care (we stipulate in the protocol that we will return them at any time the patient requests them). Finally, hospitals are not required to retain blocks forever; usually the requirement is for 10 years. Some hospitals throw away blocks after this time (often because of space issues)--this is obviously discarding potentially useful research material, and is another reason to have a tumor registry.

We will accept blocks from adenoid cystic carcinoma of the breast. Our focus is concerned chiefly with ACC of salivary gland origin (hence head and neck and lung), but in time we would like to compare the genetic findings for salivary ACC to those ACC from other sites. The breast ACC are actually a bit different from the salivary ones---pathologically and clinically (the former tend to be less aggressive).

In general, we do not intend to exhaust material in the Registry for our own research. Often there are enough blocks for a number of research projects. In the event that the amount of tumor is scant, we will not use it if at all possible. We would like to be in a position where many investigators are interested in procuring material from the Registry, but reality is such that very few investigators are studying ACC, and hence we do not expect a great demand. We will, of course, honor any individual patient's request on the handling of his/her material. If a patient would like to restrict the use of a portion of their material, then all they need to do would be to note it on the protocol forms.

There is no need for an endowment for the Registry at this time. The cost for such a Registry is not now large, and funds to support it are provided by our own department from clinical earnings by us physicians. We would be surprised if the Registry became so large that external funds to support it are needed (this would be a nice problem to have). Monies are, of course, extremely important for specific research projects--labor and materials are expensive.

In the future event that the Registry became moribund for some unforeseen circumstance, patients' materials would be sent back to the hospitals from whence they came.

OTHER QUESTIONS AND ANSWERS:

Q: I have already sent a consent form for the tumor registry. I recently had a metastatic tumor removed from my lung. Do you know if the University of Virginia is interested in the metastatic tumors also? Should I send a separate consent form?

A: Separate consents for the research use of archival tissue are not required for each new surgical procedure. However, if you could update the registry with the specific information (site of resection, date, address of hospital), that would be extremely useful.