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News (This Clinical Trial Is Open For
Enrollment)
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Location And Directions... |
The Trinitas Comprehensive Cancer Center is located at our Williamson
St. Campus.
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OBSERVATIONAL STUDY INITIATED FOR PATIENTS WITH BONE MARROW FAILURE SYNDROMES
Non-treatment, single visit study for cancer patients
Trinitas Comprehensive Cancer Center (Trinitas CCC) is participating in a
nationwide, multi-center clinical study to determine the prevalence of the
Paroxysmal Nocturnal Hemoglobinuria (PNH) stem cell mutation in patients
with bone marrow failure syndromes. As part of the Aptium Oncology Research
Network, Trinitas CCC is working in partnership with approximately 400
research sites and principal investigators throughout the United States.
The EXamination of PNH, by Level Of CD59 on REd and white blood cells, in
bone marrow failure syndromes (EXPLORE) - Aptium Oncology Research Network
Protocol* #P06-001 study is a non-treatment, single visit study to determine
the percentage of patients with Aplastic Anemia (AA), Myelodysplastic
Syndromes (MDS), and other bone marrow failure syndromes who may also have
Paroxysmal Nocturnal Hemoglobinuria (PNH).
Gerardo Capo, MD, is serving as the principal investigator locally at
Trinitas CCC. Board certified in oncology, hematology, and pain management,
Dr. Capo completed his fellowship at Memorial Sloan Kettering Cancer Center
in New York and collaborated on many research protocols on hematology and
oncology.
The primary objective of the EXPLORE clinical study is to determine the
percentage of patients with Aplastic Anemia (AA), Myelodysplastic Syndromes
(MDS), and other bone marrow failure syndromes who also have PNH cells in
their blood. PNH is an uncommon and potentially fatal blood disease that
occurs at almost any age. Found equally in men and women, the average age
for the diagnosis of PNH is 35 years. The percentage of patients with AA,
MDS, and other bone marrow failure syndromes who have PNH is unclear.
However, the determination of this number through the clinical study could
represent an opportunity to detect, diagnose, and potentially treat patients
with unrecognized PNH disease within these populations.
"The data that is obtained from this clinical trial could potentially
enhance the quality of treatment interventions for cancer patients," notes
Gary Horan, FACHE, President & CEO of Trinitas Regional Medical Center, adding, "The
physicians at Trinitas, with their extensive hematology and oncology
experience, are dedicated to providing the outstanding quality care to
cancer patients and our participation in this clinical study demonstrates
our commitment to engage in research studies that continue to advance
diagnosis and treatment."
Approximately 10,000 patients nationwide will be enrolled in the EXPLORE
clinical study. Participation in the EXPLORE study is available in New
Jersey through the Trinitas Comprehensive Cancer Center. Trinitas CCC
researchers hope to move rapidly to make the EXPLORE clinical study
available to patients. Subjects who test positive for the PNH stem cell
mutation will be notified of this result by the Principal Investigator and
may be eligible to enroll in a PNH registry program sponsored by Alexion
Pharmaceuticals, Inc., sponsor of the EXPLORE clinical study.
Participants in the EXPLORE clinical study must meet the following
requirements:
• Have AA, MDS, or other bone marrow failure syndrome;
• Be willing to comply with the procedures of the study which include
screening for basic demographic
information, history of blood transfusions, and review of eligibility to
participate in the study;
• Have drawing of a blood sample;
• Be at least 10 years of age;
• Be willing and able to give written informed consent (or in the case of
pediatric patients, parental/legal guardian written informed consent and
patient assent, as appropriate)
For additional information on this clinical study, please visit our web site
at www.trinitasccc.org
