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| Name | Class |
|---|---|
| Laboratory Corporation of America | INDUSTRY |
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Patients of scientific interest who have provided a commercial sample to LabCorp or one of its' affiliates will have their de-identified remnant samples and/or data used for research and development. Other commercial patients will be followed up on after informed consent is obtained.
Arm 1 - Remnant commercial samples and data that has been de-identified of personal health information in compliance with HIPAA may be used for R&D studies or population-based analysis by LabCorp or affiliates.
Arm 2 - Collection of samples and/or data from commercial test patients requiring follow-up or from subjects of scientific interest after informed consent is obtained.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple interventions depending on diagnostic test being run. | Device | Remnant samples and corresponding data from multiple diagnostic tests will be stored for future research and development. |
| Measure | Description | Time Frame |
|---|---|---|
| Remnant samples and data for research and development | Remnant samples and data for research and development | Retrospective and Prospective collection. Samples and data may be collected for up 12 months after enrollment. |
| Sample and data collection from subjects of scientific interest | Collect additional clinical data and samples if needed from subjects tested by LabCorp or an affiliate. | Prospective collection. Samples and data may be collected for up to 12 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Arm 1 - Female or male patient samples submitted to Sequenom or LabCorp affiliate for routine clinical care testing that no longer need to be maintained for clinical purposes.
Arm 2 - Female or male subjects of scientific interest who have provided written informed consent/assent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Graham P Senior Director | Contact | (858) 202-2000 | mclenng@labcorp.com |
| Name | Affiliation | Role |
|---|---|---|
| Graham P McLennan | Sequenom, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sequenom, Inc | Recruiting | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Commercial remnant samples stored at multiple LabCorp affiliates.