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Mahul Amin, M.D., Chair
Central Review Status
The Excel file of studies under central review status was reviewed. An update of activities was provided which include a central review for RTOG 9202 which was completed. A central review for RTOG 9408 & 9910 was completed using our new approach of reviewing at least 25% of randomly selected cases. To date reviews for RTOG 9811, 9506, 9706 and 9902 have not been started. Karan Boparai will contact Dr. Rashid regarding RTOG 9811, Dr. Wu regarding RTOG 9506 & 9706 and Dr. Grignon regarding RTOG 9902 to inquire if any of them need assistance with the reviews. RTOG 9601 reviews are anticipated to be completed by this summer. RTOG 0330 was closed in March of this year. Karan Boparai will follow up with Dr. Lucas to determine if he is able to complete reviews or if he needs assistance.
Tissue Bank Update
The data entry into Freezer Works is 70% complete. A one day reverse site visit will be scheduled to take place in the coming months at RTOG Headquarters for new tissue bank applicants. This will determine a new Tissue Bank Director and location. Copies of the tissue bank inventory were distributed and reviewed.
A discussion ensued regarding revisions to the consent form stating the institution must notify patients who consented to banking tissue in the event their tissue is not sent to the tissue bank. This is to maximize tissue submission when a patient consents to tissue banking.
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Mahul Amin, M.D., Chair
RTOG Central Pathology review has a table of on-going RTOG studies involving different organ systems which was shared with the rest of the committee. The status of these studies including target and case accrual were discussed and the central review was coordinated to keep up with the study time frame.
The pros and cons of prospectively collecting and storing urine specimens were discussed. A problem appeared to be in transportation during which vials were broken. Dr. Hammond and the tissue bank are looking into better transportation and storage.
The need for having lung tissue for translational research was emphasized. Yuhchyau Chen, M.D. Ph.D. from University of Rochester has a thoracic surgeon colleague Carolyn Jones, M.D. who will help in tissue procurement similar to the head and neck tissue bank for the RTOG 0514 protocol. They will develop a protocol and work with the RTOG tissue bank to prospectively archive specimens.
An abstract from the central review of prostate Gleason grading from RTOG 8610, 9202, 9413 and 9910 is to be presented at the United States and Canadian Academy of Pathology meeting in San Diego in March 2007. The findings in the study will help determine trends in community Gleason grading and whether review of representative cases was adequate.
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Mahul Amin, M.D., Chair
RTOG Site Visit and Grant Preparation: Dr. Amin attended the RTOG site visit and grant preparation meeting. Members of the Pathology Committee were updated with the plan for submission of the grant. Dr. Amin made a presentation at this meeting and the contents of his presentation were shared with the rest of the committee.
RTOG Tumor Bank Update: Justin Bryner presented an update compilation of the number of slides, blocks and fresh tissue that are available for each organ system in the RTOG Tumor Bank. An update of serum resources in select protocols was also discussed.
Dolores Malone, Justin Bryer and Dr. Amin have prepared an updated excel spreadsheet of all studies in which Pathology Committee members have a role in the central review. This was shared with the Pathology Committee.
New tissue microarrays are being created for cancer of prostate, bladder, pancreatic, esophageal and anal canal were presented to the committee.
There is a need for a lung pathology expert for new protocols which was discussed.
The committee was updated on a CDNA microarray study for prostate cancer using fresh tissue.
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Mahul Amin, M.D., Chair
I. Pathology Central Review: Considerable time was spent discussing the central review process and protocols that are currently under review. A tracking mechanism of the number of cases on the central review has been instituted, and guidelines for coordination between the headquarters and LDS hospital were discussed.
II. RTOG Tumor Bank Update: Holly Flinner presented an up-to-date compilation of the number of slides, blocks and fresh tissue that are available for each of the organ systems in the RTOG Tumor Bank. An update of serum resources in select protocols was also discussed.
III. There was discussion concerning potential harvesting of fresh tissue for molecular studies. Dr. Amin will discuss prospective organ sites with the members and TRP committees to assess the need for fresh tissue. A study in prostate cancer is being planned, and the process is being employed for the prostate cancer protocol, which was discussed with the committee.
IV. New tissue microarrays are being created for prostate cancer; bladder cancer, pancreatic cancer, esophageal cancer and anal canal carcinoma were presented to the committee members.
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Elizabeth Hammond, M.D., for
Mahul Amin, M.D., Chair
The Pathology Committee met with Dr. Hammond directing the meeting in the excused absence of Dr. Amin. Dr. Hammond reviewed the status of the tissue bank. Additional tissues have been received as expected and several new tissue arrays have been completed, included one for pancreas and rectum. Dr. Hammond and Ms. Flinner have been working with headquarters to define a new database and data collection systems, which will be web-based. The system will also incorporate suggestions for TRP data acquisition from marker studies using the web based data acquisition program of Marius vanRikjovre. They will continue this dialogue by conference call. Having a web-based system will enhance the access to tissue bank information while facilitating continued smooth functioning at LDS Hospital. Several recent investigations have highlighted the quality of the tissue bank samples. Dr. Brat reported that all of the brain tissues used in his recent FISH investigations were adequate for evaluation with the exception of tissues from RTOG protocol 7401. Thus the stability of DNA in tissue blocks back to 1976 is adequate. Dr. Stuart Wong reported on his evaluation of DNA extracted from blocks of RTOG 9003. Extracts of laser capture sections of several tumors were adequate to evaluate mutations of p53 (Exon 8). Dr. Hany Elsaleh reported on his evaluation of samples from RTOG 9708, in which successful DNA extraction was possible from 96% of pancreatic array spots. Dr. David Gaffney reported that the RNA extraction from cervical specimens collected on RTOG 0128 was adequate in 80% of samples. These reports indicate that the collection procedures of the group are adequate to insure useful collection of samples for various investigations.
Headquarters have been working to streamline the process of application for tissue bank funds. This process will also be applied to TRP seed grant applications and will be enhanced by the hiring of a full time TRP headquarters coordinator, Ms. Dolores Malone.
The status of trials with central review was reviewed. Dr. Amin had provided input that he was communicating with Dr. True and would report back shortly about the disposition of the delinquent reviews of RTOG 9408. He will also follow up with Dr. Grignon on the status of his reviews. The group reviewed the entire list of protocols and made a recommendation that a list be generated for future meetings which would be separated into sections including those studies for central pathology review, studies with serum collection, and studies with specified TRP studies (which should be specifically described in the comments section). Dr. Hammond will work with Ms. Malone on the development of this form.
Dr. Hammond indicated that the NCI is planning to streamline the tissue banking activities of various tissue banks throughout the United States. Dr. Hammond will contact Roger Aamodt and make sure the RTOG is well connected to this initiative.
The status of reimbursement to pathologists was discussed. It will be imperative to be sure that reimbursements go to the individuals who are doing the work and not to just the radiation oncology department. This will be particularly important as further fresh tissue protocols come on line.
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Mahul Amin, M.D., Chair
I. Dr. Asif Rashid from M. D. Anderson Cancer Center is a new member of the Pathology Committee. The Committee was made aware of Dr. Rashid’s qualifications and areas of interest.
II. Pathology Central Review: An updated form listing the status of all studies under central review was circulated to the Pathology Committee members. This form lists the protocol number, reviewer, number of accrued cases, and status of the central review.
III. RTOG Tumor Bank Update: Dr. Hammond presented an up-to-date compilation of number of slides, blocks and fresh tissue available for each of the organ systems in the RTOG Tumor Bank. Dr. Hammond informed the committee of increased reimbursement to pathology departments for tissue contribution. The Tissue Bank will maintain relationships between levels of consent before tissue is used for any study in the pathology component of the protocol.
IV. Generation of New Tissue Microarrays: New tissue microarrays are being created as per request. A request for vocal cord squamous cell carcinoma tissue microarray was to be submitted to the Steering Committee. All immuno studies on tissue microarrays could be interpreted in a standardized fashion using the ChromaVision Image Analyzer (in the RTOG tissue lab at LDS Hospital; this adds objectivity to the immuno-interpretation while maintaining the pathologist’s selection and interpretation ability. Also, all studies performed on previous sections obtained from the same tissue microarray will be available such that if an investigator now performs a new immunomarker study on a series of tumors, the investigator could get access to all previous immunomarkers that were subjected such that correlative studies between markers could be performed if appropriate and necessary.
V. New TRP forms have now been created for investigators to request tissue and pathology studies. The Pathology Committee was made aware of this new TRP form; it was suggested that a future news letter update the RTOG membership of this mechanism to apply for translational studies.
VI. Frozen Tumor Bank: The status of specimens in the Frozen Tumor Bank was discussed. The need for banking prostatic needle biopsies was also discussed for the cDNA microarray studies currently being planned by the GU/TRP group.
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Mahul Amin, M.D., Chair
I. Pathology Central Review: Considerable time was spent discussing the central review process and the protocols that are currently under central review. The status of protocols under central review (RTOG 92-02, 94-08, 95-06, 95-12, 96-01, 98-05, 99-02, 97-06, 99-06, 98-11, 99-10 and 90-03) was discussed. The mechanism of coordination of central review between the study pathologists, LDS Hospital and headquarters was discussed to streamline the process.
II. RTOG Tumor Bank Update: Dr. Hammond presented an up-to-date compilation of the number of slides, blocks and fresh tissue that are available for each of the organ systems in the RTOG tumor bank. An update of the serum resources in select protocols was also discussed.
III. Generation of New Tissue Microarrays: Tissue microarrays were being created for pancreatic cancer, esophageal cancer and anal canal carcinoma. Some of the members of the Pathology Committee were interested in creating new tissue microarrays for transitional studies; the process of obtaining approval to begin creating the tissue microarrays was explained to them.
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Mahul Amin, M.D., Chair
I. New Initiatives:
A. There is interest in the GU Translational Research Program to develop gene expression profiling by cDNA micro array technology within the RTOG. Towards this end, Dr. Pete Nelson from the University of Washington in Seattle has been recruited to the Pathology Committee to bring and lead the technological aspects of the cDNA micro array studies. The Pathology Committee is planning to embark on a small pilot study using prostate needle biopsies; if successful, the technology will be made more available to other site committees.
B. An important prerequisite of the cDNA micro array studies is the availability of fresh or frozen tissue. The current status of the frozen tumor bank of the RTOG was discussed as well as proposal and ideas for performing cDNA micro arrays. The possibility of creating satellite site-specific tumor banks was considered and will be discussed with Dr. Hammond. There was considerable input, discussion and interest among members of the Pathology Committee and the radiation oncologists for this new initiative.
C. Proposals for new studies were discussed; these included studies on esophageal cancer and brain tumors. A need to develop tissue micro-arrays for brain tumors was expressed, and this will be coordinated with Dr. Hammond.
D. Members of the Pathology Committee presented an update on studies in progress, being presented or in preparation as a manuscript.
II. RTOG Tumor Bank Update: Amy Furness presented the status of the RTOG Tumor Bank on behalf of Dr. Hammond; this included an up-to-date compilation of the number of slides, blocks and fresh tissue that we have for each of the different organ systems in the RTOG Tumor Bank accrued by the RTOG protocols.
III. Pathology Committee members were asked to provide an update on participation in RTOG protocols and comment on central pathology review issues.
IV. Other Business: There was concern expressed by some of the tumor registrars and radiation oncologists regarding obtaining IRB permission at their respective institutions. Stringent interpretation of IRB regulations was felt to impact negatively on recruitment of patients into RTOG protocols. Since their concerns would likely be more suitably addressed by the RTOG leadership, it was decided that Dr. Amin (Chair) will discuss the concerns regarding IRB-related issues with Tom Wudarski. The attendees suggested that a document be prepared by the RTOG outlining their position regarding IRB approval. This document could then be used by tumor registrars, nurses and radiation oncologists as an educational tool and a resource not only for patients but also for institutional IRBs.
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Mahul Amin, M.D., for
David Grignon, M.D., Chair
1. Dr. Elizabeth Hammond discussed all of the issues and concerns pertaining to the Pathology Committee that were brought up at the recent site visit by the National Cancer Institute. Several members of the committee provided suggestions where they felt that the site visit’s concerns could be addressed and explained in the “response.”
2. Dr. Hammond provided an update on the status of the tumor bank.
3. Dr. Pajak provided a list of the abstracts that were presented at national meetings by members of the pathology committee. An outline for pursuing these abstracts to the manuscript form was discussed with the respective members who were present.
4. The committee members were apprised of the tissue micro arrays that were developed or are in the process of being developed for potential translational research. Several new projects were discussed.
The Pathology Committee members’ participation in future initiatives such as the cDNA microarray technology and a possible frozen tumor bank were discussed.
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David Grignon, M.D., Chair
Dr. Grignon opened the meeting by welcoming Dr. Mahul Amin as a new
member of the Pathology Committee. Dr. Amin is an internationally recognized expert in the area of urologic pathology from Emory University and will be participating in prostate trial reviews. Pathology reviews of currently open or recently closed protocols were discussed. Dr. Hammond updated the committee on tissue bank activities and provided a listing of accrued materials. There was considerable discussion around the use of tissue microarrays within the RTOG tissue bank. Dr. Hammond described
an ongoing quality control study to determine the validity of this approach using materials from head and neck, glioma and prostate trials. If these are successful this methodology could greatly enhance the life span of mateials in the bank, increasing the numbers of projects which could be completed. The committee also discussed the need to recruit additional faculty to fill holes in some sites and to replace pathologists that are leaving the committee.
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