University of Pennsylvania Mesothelioma Collections September 2008 through September 2009

Work-Flow Patient Consent Surgery Tissue Collection Patient Care will always trump tissue collection for research. As a result, tissue collections for TTAB are driven purely by the combined effort of key players forming a seamless collaborative relationship. The Patient drives the process from the start.

Collaborative Effort Patient The Patient holds the collaboration together, the glue to the entire process. Without the patient’s consent the effort never takes root.

Process Dr. Anil Vachani’s IRB-approved consent for research. Melissa Culligan approaches the patient to consent after diagnosis & prior to surgery. Dr. Joseph Friedberg performs the surgical procedure. OR Charge Nurse pages TTAB Technician when tissue is available. TTAB Technician collects tissue & fluids and processes the biospecimens for cryopreservation. Once a patient is consented, Melissa contacts the TTAB technician with the patient’s information. On the day-of-surgery, the TTAB technician tracks the progression of the surgical procedure using NaviCare, the hospital’s patient tracking software. One hour after incision occurs the technician accesses the OR to collect blood and urine, if available, and returns to the TTAB bench located within Surgical Pathology, which is 2 minutes away. While processing the fluids at the TTAB bench, the Tech will receive a page that tissue is available for pick-up. Consent for research is for Tissue, Blood, urine, and future contact. Asbestos exposure or diagnosis of mesothelioma is necessary. Blood isn’t available for every surgery for various reasons. For example the patient may be anemic and can’t handle the 50cc draw or there is no arterial line to draw from, in the case of some biopsies.

The Collection

The Collection What happens to the tissue? Once Collected, the tissue & fluid is taken to the dedicated TTAB bench located two minutes away within Surgical Pathology. Having the bench located in such proximity has enabled TTAB to preserve biospecimens in under 30 minutes warm ischemic time. Often times in under 10 minutes. The tech is trying to preserve the tissue into samples of snap-frozen, OCT embedded, & FFPE, and with so much tissue collected, the challenge is to have a ratio of 2:2:1 (SNFR, OCT, FFPE). The rational being that more science can be done with a snap-frozen piece of tissue.

QA Histologic confirmation & classification by Dr. Feldman. Technician enters data in NMVB database.

Major Players

Abramson Cancer Center Anil Vachani, M.D. Assistant Professor of Medicine Pulmonary, Allergy and Critical Care Division Abramson Research Center Detection of Mesothelioma Blood Biomarkers: This project, led by Dr. David Speicher (Wistar) and Dr. Albelda, uses novel proteomic and genomic technologies to identify potential biomarkers for the early detection of mesothelioma. In its later stages, the project will test the diagnostic utility of novel markers in cohorts of cancer and controls patients. Anil Vachani has been instrumental in allowing TTAB to be included in his IRB approved research protocol, thus opening the door for Meso biospecimen collections. Without Anil, we would not be a contributing member of NMVB.

Presbyterian Hospital, Thoracic Surgery Joseph S. Friedberg, M.D. Chief, Division of Thoracic Surgery, Penn-Presbyterian Medical Center Associate Professor of Surgery Dr. Friedberg heads many investigational trials to develop treatments for advanced cancers and malignant mesothelioma and maintains a special interest in photodynamic therapy (PDT) as a tool in the fight against advanced cancers. Just a few of his publishing credits include: Innovative therapies: photodynamic therapy, Thoracic Surgery Clinics; Phase II trial of pleural photodynamic therapy and surgery for patients with non-small-cell lung cancer with pleural spread, Journal of Clinical Oncology; A phase I study of Foscan-mediated photodynamic therapy and surgery in patients with mesothelioma, Annals of Thoracic Surgery, and Gene expression profiling of malignant mesothelioma, Clinical Cancer Research. Dr. Friedberg’s clinical interests are in diseases of the pleura. Dr. Friedberg heads many investigational trials to develop treatments for advanced cancers and malignant mesothelioma, including the development of a lung cancer vaccine. In addition to his current positions, his research, and patient-care, Dr. Friedberg also Directs the Penn Presbyterian Thoracic Research Laboratory. The laboratory is focused upon several areas of interest including both oncologic and nononcologic topics.

Hospital of the University of Pennsylvania Michael D. Feldman, M.D., Ph.D. Associate Professor of Pathology and Laboratory Medicine at the Hospital of the University of Pennsylvania Director, Anatomic Pathology Informatics Director, Tumor Tissue & Biospecimen Bank (TTAB) Assistant Dean, Information Technology, Medical School Academic Programs

Presbyterian Hospital, Thoracic Surgery Melissa Culligan, RN, BSN,CCRC Melissa Culligan's expertise is in thoracic surgery and thoracic oncology research. Melissa has been the point-of-contact for TTAB throughout the Mesothelioma Collection Project. Melissa is responsible for the patient consenting and notification to TTAB of future dates for surgical procedures. There’s not enough I can say about Melissa. Her tireless determination cannot be captured in words. Her willingness to participate and make this project a success is a testament to her work ethic.

Hospital of the University of Pennsylvania Federico Valdivieso Technical Director/ Lead Technician (I need to add info…)

Prospective Collections Sept. ’08 through Sept ’09 17 Surgical Cases: 8 Pleurectomies 5 Pneumonectomies 2 Biopsies 2 Thoracenteses

What’s this mean to NMVB as a resource?

Prospectives’ Specimen Yield, in Total… Tumor Tissue: 139 Fresh-frozen tumor samples 87 OCT blocks of tumor 78 Paraffin embedded blocks Normal Adjacent Tissue: 4 Fresh-frozen tissue samples 2 OCT blocks of tissue Blood, Derivatives & Urine: 339 Plasma aliquots 69 Serum aliquots 40 Packed RBCs 20 PBMC aliquots 21 Whole bloods 35 Buffy coat aliquots 7 Urine aliquots This is the total of all 17 procedures. The breakdown by procedure is next…

8 Pleurectomies: Tumor tissue: 96 Fresh-frozen tissue samples 53 OCT blocks of tissue 52 Paraffin embedded blocks Blood, derivatives & urine: 189 Plasma aliquots 36 Serum aliquots 20 Packed RBCs 6 PBMC aliquots 10 Whole bloods 24 Buffy coat aliquots 7 Urine aliquots

5 Pneumonectomies: Tumor tissue: Normal tissue: Blood & derivatives: 40 Fresh-frozen tissue samples 33 OCT blocks of tissue 24 Paraffin embedded blocks Normal tissue: 4 Fresh-frozen tissue samples 2 OCT blocks of tissue Blood & derivatives: 130 Plasma samples 24 Serum samples 15 Packed red-blood-cell samples 12 PBMC samples 9 Whole blood samples 8 Buffy coat samples

2 Biopsies (only one case with an A-Line for blood) : 1 OCT block of tissue 3 Fresh-frozen tissue samples 2 Paraffin embedded blocks of tissue 2 Whole blood samples 20 Plasma samples 9 Serum samples 3 Buffy coat samples 5 Packed red-blood-cell samples 2 PBMC (peripheral blood mononuclear cells) samples

2 Thoracenteses (diagnosed with mesothelioma) : 30 milliliters of pleural fluid per case. which means… a total of 60 aliquots of 0.5 ml of pleural fluid.

Retrospective Collections 29 Retrospective Plasma samples provided to TTAB for NMVB by Dr. Vachani from his archive collection. Identified 20 ~ 30 paraffin embedded samples in HUP’s archived clinical cases from the 2007-2008 surgeries. If eligible, these would be added to the Retrospective collections portion of NMVB database.

TTAB, the Facility… Occupied for just under a year… TTAB has operated out of temporary offices, closets, server rooms, etc. for a year & a half prior to moving into the new facility. We did whatever it took, as long as we had dedicated bench space, to do our job.

The Freezer Room Housing two -80 freezers and three -140 freezers, the freezer room is monitored 24/7 with staff providing on-call services in the event of… Well, you know… (we don’t like to mention it)

Hint

The Lab Fully equipped for biospecimen processing, whether it is tissue to be fresh-frozen in liquid nitrogen, frozen in OCT, fixed in formalin & embedded in wax, or blood needing to be centrifuged into its components. Slide preparation is also a routine process at TTAB.

Plenty of room for growth in the years to come… The Lab Plenty of room for growth in the years to come…

The Imaging Room Slide imaging equipment is a recent acquisition at TTAB. We seek to integrate this technology into all projects.

Thank you.

Special thanks to… Nancy Whelan, Dr. Michael Becich, & Dr. Waqas Amin

Its not just a specimen, its a patient.

One of my favorite illustrations… this goes out to the entire NMVB team and research community…