NIH, National Heart, Lung, and Blood Institute, COB, Procurement Section, 6701 Rockledge Drive MSC 7902, Bethesda, MD 20892-7902

A -- CLINICAL COORDINATING CENTER FOR LUNG VOLUME REDUCTION SURGERY FOR EMPHYSEMA: A MULTI-CENTER ASSESSMENT AND PROSPECTIVE PATIENT REGISTRY SOL NHLBI-HR-97-01 POC Joanne C. Deshler, Contracting Officer, (301)435-0340. The National Heart, Lung and Blood Institute of the National Institutes of Health and the Health Care Financing Administration will jointly sponsor and support a seven year multi-center randomized, clinical trial in association with a prospective registry to examine the role of Lung Volume Reduction Surgery (LVRS) in the treatment of end-stage emphysema, evaluate the long term outcome of LVRS on function, morbidity and mortality and define appropriate patient selection criteria for the procedure. The program will consist of approximately 10 to 15 clinical centers and a clinical coordinating center (CCC). The clinical centers will be awarded under a separate RFP NHLBI-HR-97-02. A registry will be established to serve as a repository of severe end stage emphysematous patients, who have been referred for evaluation for LVRS, transplant or pulmonary rehabilitation to any of the participating clinical centers. Patients in the registry meeting selection criteria will be invited for inclusion in the randomized study. Patients, who are not randomized, but agree to be in the registry will be followed twice yearly. Patients meeting eligibility requirements will be randomized to receive either maximal medical therapy or maximal medical therapy with LVRS. LVRS will be performed by median sternotomy or by bilateral video-assisted thorascopic surgery (VATS)with excision of 20-30% of each lung. Centers will apply to randomize to either a) medical therapy versus medical therapy with LVRS by median sternotomy, b) medical therapy versus medical therapy with LVRS by bilateral VATS or c) medical therapy versus medical therapy with LVRS by median sternotomy versus medical therapy with LVRS by bilateral VATS. Maximum medical therapy will include pulmonary rehabilitation and education. End-points will include exercise ability, pulmonary function, quality of life, morbidity and mortality. The study population will consist of 200 patients recruited into each arm of the three arm trial comparing surgery A versus surgery B versus medical therapy. An additional 495 patients will be recruited into each of two arms among clinical centers performing only one kind of surgery and medical treatment. This will require a total of 2580 participants in the three armed and two arm trials combined for the randomized, clinical trial. The study will be conducted in three phases. Phase I (9 Months) will be for development of a protocol and manual of operations and recruitment and training of personnel. During this phase the CCC staff will collaborate fully with the clinical center principal investigators in the development of the study protocol and the manual of operations and provide statistical and organizational expertise. Phase II (63 Months) will be for recruitment of patients, randomization and follow-up of subjects. During this phase the CCC will receive, collect, process, store, and analyze data collected from the participating clinical centers. The CCC will assure compliance of the clinical centers with patient entry and randomization criteria, recruitment schedules, pulmonary rehabilitation, medical and surgical study protocols and other guidelines in the manual of operations. The CCC will conduct site visits, assure that data are forwarded in accordance with an established time schedule, review data for accuracy and completeness, assure that quality control is maintained during the collection and processing of data. The CCC will prepare and distribute periodic technical and statistical reports to the participating clinical centers, the project officer, a HCFA representative and the contracting officer. Phase III (12 Months) will be for analysis of data and writing of manuscripts describing results of the study. During phase III, the CCC will collaborate with the study investigators and the project officer to conduct the final analyses of the data and to write manuscripts describing results of the study. Throughout the study, the CCC will coordinate, manage and participate in meetings of the Steering Committee with direction from NHLBI, produce and distribute minutes of these meetings, assist the Project Officer in preparing the agendas for periodic meetings of the Data Safety Monitoring Board and make presentations at the Policy Board meetings. The CCC must have experience with complex multi-center trials and registries, readily available medical expertise relevant to emphysema, pulmonary medicine and thoracic surgery and the ability to analyze a large volume of physiologic, surgical and medical morbidity and mortality data. The CCC will frequently need to make quick decisions, often based on medical information obtained from the clinics. Therefore, staff will need to possess the strong medical and scientific qualifications and experience relating to Chronic Obstructive Pulmonary Disease (COPD) and LVRS to interact effectively as peers with the multiple medical disciplines (surgery, pulmonary, rehabilitation, radiology, anesthesiology, and physiology) represented in this program. This is not a request for proposals. It is anticipated that RFP NHLBI-HR-97-01 will be available on or about June 3, 1996, with proposals due on or about August 5, 1996. Award of a contract for this study shall be made only to offerors who are located in the United States of America. The RFP will be available on the NIH RFP Gopher. Access via the NIH Home Page (World Wide Web) at http://www.nih.gov. Once you are at the NIH Home Page select ''Grants & Contracts'' then select ''R&D Requests for Proposals (RFP)''. Offerors that have access to the NIH Gopher Server but not the Internet can access the RFP by pointing your gopher client to GOPHER.NIH.GOVPORT70. Select ''Grant and Research Information'', then select ''R&D Request for Proposals (RFP)''. (0129)

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