The informatics working group of the Texas Cancer Genetics Network met on April 8, 1999 at 4 p.m. via teleconference. Present were:
Chris Amos
Jihong Zong
Constance Johnson
Jerry Kyle
(all U.T.M.D.A.C.C)

Gail Tomlinson (U.T.S.W.)

Sue Hilsenbeck
Denise Wahl
Bess Buzzini
(All U.T.H.S.C.S.A.)

No one from Baylor College of Medicine could attend, but Sue Hilsenbeck was able to partially represent BCM.

First, the group discussed the impending Pilot # 2 of the CGN core data elements questionnaire. This pilot requires that data be collected from patients or healthy individuals. Data are to be stored in a database that will be transcribed via electronic submission to the UCI site. The deadline for submission of data will be June 4. Therefore, collection of data must begin soon. For the current pilot, only 20 questionnaires need to be completed. Dr. Amos suggested that UTMDACC or BCM might be best equipped for this piloting phase. However, Dr. Tomlinson said that her group is willing and ready to collect questionnaire data. Currently, her group is already collecting some data, but not following the exact format required by the core data elements questionnaire. Thus, to comply easily with the pilot, she proposed transcribing data that are collected onto the core data elements form.

Dr. Hilsenbeck had attended the last teleconference call meeting of the core data elements working group of the CGN and provided some updates. A script for administering the core data elements questionnaire is being developed by Joellen Schildkraut and colleagues at Duke University. According to a recent e-mail received by Dr. Amos, this script has now been posted at the UCI website. In addition, the website contains the latest versions of questionnaires for the core data elements as well as minutes and other information from meetings. To access the website, the login is ******* and the password is "****". Recently, a modification of the core data elements questionnaire for self-administration and a script for personal interviews have been added to the website and can be downloaded. However, attached to this document is the self-administered form.

Dr. Amos provided some feedback on interactions he had had with Maureen Gildea about the structure of the core data elements database. Dr. Hilsenbeck had expressed concern that the current form of the GRIS database used by UCI was not configured to accept the type of data that are being collected through the core data elements. Ms. Gildea indicated that she is aware of this and the core data elements database is being appropriately configured. Dr. Hilsenbeck also brought up the issue of multiple probands. Currently there is no mechanism for identifying families that have been multiply identified or to indicate in a family who the proband(s) is (are). This problem should be amended and needs to be brought to attention of the core data elements.

Next, some discussion focused on coding of cancers. Coding will follow ICD-02 which is a subset of ICD10. ICD-02 obtains site, typography and morphology of cancers and so is more detailed than ICD9. In addition, twice as many cancer types are included in ICD-9. Dr. Amos indicated that most information from relatives would be missing typography and morphology. However, standard conventions for NOS can be used where there is missing data. Dr. Hilsenbeck indicated that all tumor registries are going to ICD-02. Constance Johnson indicated that she has received software from the World Health Organization for converting ICD-9 codes to ICD-10 codes.

Some discussion addressed protocol development and informed consent issues. In order to obtain a certificate of confidentiality, all centers must provide to the NIH IRB approved protocols in early April. Dr. Amos provided a summary from the Steering Committee meeting in February. At that time, Dr. Hanson was suggesting that registering patients at the present to the CGN might be premature. Patients registered before the certificate of confidentiality is obtained would not be covered by it, and might have to be reconsented. At the recent steering committee teleconference on April 20, most P.I.s of the CGN expressed concern about the strong wording about risks to study participants that are included in the model informed consent document. A task force headed by Dr. Hanson is investigating whether or not such strong wording will be required for inclusion as a part of the consent process. Currently, the Utah and U Penn groups have developed informed consent documents that do not conform to the model informed consent and this deviance required further study. The Utah group deviated from the model informed consent because they are attempting population based studies, and they were concerned about loss of patients. U Penn did not adhere to the model informed consent because they did not feel that it accurately described the minimal risk that will accrue to a study subject based upon participation in a survey.

The group discussed the creation of the TCGN website. Jerry Kyle is actively working on the website. He intends to create the website in the next few weeks. He is requesting ideas for a Logo. The initial form of the website will include minutes of meetings, working groups and should include information to indicate how patients can register to the TCGN. Bess Buzzini and Kyle Larson have expressed interest in assisting with the website.