| FAQ |
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| What is the chain of custody for specimens? |
| Access to the samples and database information is only permitted by authorized members of Oncology Metrics. Samples are stored in a -84°C biorepository freezer at the Oncology Metrics office in Fort Worth, Texas.
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| How is the integrity of the samples maintained? |
| Our staff provide 24/7 response to alarm conditions. Backup generator and automatic CO² transfer switches safeguard against loss of electrical power.
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| How are the aliquots labeled and identified? |
| The aliquots are labeled at the practice site with the patient name, medical record number and date of blood draw.
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| When an aliquot is received at Oncology Metrics, the aliquots are labeled with a new barcode label. The barcode is linked to the patient’s medical record number only.
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| Are the serum samples restricted to specific cancer types or all types? |
| The serum samples are gathered from patients with all types of cancer.
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| Is serum the only type of sample required from the patients and protocol sites? |
| The standard protocol requires serum samples. However, Oncology Metrics also offers prospective custom collection of samples including bone marrow, plasma, whole blood, tissue and buffy coat.
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| Will patients be asked for blood samples if the physician does not order blood tests? |
| In general, patients will not be asked to give serum samples without a physician-ordered lab test. The remainder of the blood left over after tests have been performed is spun down to the serum level and 1 ml of serum is poured off into the 2 ml aliquot.
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| Prospective studies may require patients to provide additional specimen samples, but the permission of the patient and the patient’s physician will always be obtained in advance.
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| How is Oncology Metrics specimen collection regulated? |
| All specimen collection is conducted under an IRB-approved research protocol, offering a valuable resource for clinical research organizations and diagnostic testing companies. IntegReview, a national IRB organization, monitors and reviews Oncology Metrics' specimen collection protocols on an annual basis.
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| Is the data collected through the Cure Pace Network confidential? |
| Yes. All identifying information is removed prior to being received by the Cure Pace database. All proper ethical standards and current requirements for patient confidentiality regulations are followed.
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| Is there any compensation for patients or protocol sites? |
| Patients are not compensated for their participation. The protocol sites are reimbursed an administration ‘collection’ fee for the samples and electronic patient records.
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| How do practices order supplies and arrange for shipping? |
| Oncology Metrics will order all the supplies for the protocol site including the aliquots, storage boxes and any necessary supplies the site may need for the laboratory. Oncology Metrics will also arrange for the shipping as well as cover the expenses of the shipping.
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| How many samples will a practice need to collect from each patient? |
| Each time a lab test is ordered for a patient by the physician, a serum sample will be collected from the leftover blood/serum after tests are completed. This will continue as long as the patient continues to see the physician for treatment and/or blood tests.
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| Can a patient participate in the specimen collection through the Cure Pace Network and also participate in a clinical trial at the same time? |
| No. If a patient is participating in a clinical research trial, then the patient cannot be enrolled in the Oncology Metrics program as this prevents Cure Pace samples and data from being skewed, and prevents interference with the clinical trial. If a patient is enrolled in the Cure Pace program and the patient’s physician determines the patient is a candidate for a clinical trial, then the patient will be removed from the Cure Pace program to engage in the clinical trial. Should the patient complete the clinical trial, then the patient may resume with the Cure Pace program again after signing another new Informed Consent.
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| Can any cancer center be part of the Cure Pace Network? |
| To be eligible for participation in the Cure Pace Network, a practice must have an active EMR system in place and sufficient staff to complete the work of the protocol. |
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