SOLICITATION NOTICE
A -- Cytogenetic (Chromosomal Study) Core Laboratory for the Multicenter study of Hydroxyurea in Sickle Cell annemia (MSH) Patients' Follow Up, Extension 1
- Notice Date
- 4/22/2004
- Notice Type
- Solicitation Notice
- NAICS
- 446199
— All Other Health and Personal Care Stores
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- Reference-Number-MMRICCL-01
- Response Due
- 6/1/2004
- Archive Date
- 7/15/2004
- Point of Contact
- Joann Ciufolo, Contracting Officer, Phone (301) 435-0359, Fax (301) 480-3432,
- E-Mail Address
-
jc84g@nih.gov
- Description
- As prime contractor to the National Heart, Lung, and Blood Institute, NIH, under Contract N01-HB-67129, entitled: Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH) Patients? Follow Up, Extension 1, Maryland Medical Research Institute (MMRI), has need for the services of a Cytogenetic (Chromosomal Study) Core Laboratory with demonstrated expertise in performing cytogenetic (chromosomal study) assessments for patients. The subcontracted laboratory will be called the MSH Patients? Follow Up Cytogenetic Laboratory. The specific intent of the MSH Patients? Follow Up is to determine the safety of hydroxyurea in long term follow up of adult patients who have sickle cell anemia. The purpose of the Medical Coordinating Center (MCC) for the MSH Patients? Follow Up is to provide support for this multicenter collaborative research effort evaluating the safety of hydroxyurea. Approximately 207 patients, from twenty-one participating Clinical Centers, are eligible to be enrolled in the MSH Patients? Follow Up?Extension 1. Recruitment will begin in the first half of 2004. A cytogenetic (chromosomal study) blood specimen will be collected for each patient. Cytogenetic determinations from blood samples will be collected to determine each patient?s chromosome morphology. Abnormalities of chromosome morphology have been found in sickle cell anemia patients who are not treated with hydroxyurea. Hydroxyurea has been demonstrated to be clastogenic in onion root tip systems. Because hydroxyurea has been suspected to be a cause of mutations with oncogenic potential, it is important to know if any chromosomal abnormalities associated with malignancy are present in the course of hydroxyurea treatment. Thus, it is important to know the chromosomal morphology of Study participants during the Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH) and the current MSH Patients? Follow Up?Extension 1. Blood in small vacutainers with sodium heparin will be shipped overnight by courier from each of the twenty-one Clinical Centers to the Cytogenetic Core Laboratory where the specimens will be processed to determine chromosomal morphology. Each small vacutainer will be labeled with a unique identifying number only, to assure patient confidentiality and integrity of specimen analyses. The Cytogenetic Core Laboratory will contract directly with MMRI and shall be able to: 1) Process approximately fifty (50) specimens each year for approximately four years. 2) Provide chromosome morphology studies on cells harvested after appropriate cell culture which shall be initiated the day of specimen receipt. 3) Provide materials for the MSH Clinical Centers to collect and ship specimens in small vacutainers with Sodium heparin anticoagulant for whole blood (4 ml). Shipment to the Cytogenetic Core Laboratory shall be in IATA-approved, cool-pack containers by courier. 4) Provide written procedures for Clinical Center staff to collect and ship specimens to the Laboratory. 5) Receive and document condition of specimens from the Clinical Centers. 6) Communicate electronically all results to the MCC within three weeks of receipt of specimens. 7) Maintain an inventory of specimens (i.e., number of each type of specimen, date of collection, and ID number) to be provided to the MCC upon request; 8) Store residual cell pellets and plasma at -70 degrees C and send batches to the NHLBI Specimen Repository once each year; 9) Provide reports of activities to the MCC on an annual basis; and 10) Perform determination of complete karyotype and assessment of chromosomes for breakage (including chromatid breakage), translocations, gaps, inversions, centromere/satellite and other morphological abnormalities. The RFP (including Protocol) is available electronically at www.mmri.org by double clicking the button entitled RFPs or by contacting Mary Anne Dresler, M.B.A., 600 Wynhurst Avenue, Baltimore, Maryland 21210-2425; FAX: 410-323-8622. MMRI intends to negotiate one contract for the period of approximately four years with an approximate date of award July 15, 2004.
- Record
- SN00570874-W 20040424/040422211724 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |