Cancer, Infectious Disease, Pregnancy Related
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMultiple interventions depending on diagnostic test being run.
Remnant samples and corresponding data from multiple diagnostic tests will be stored for future research and development.
Sponsors
Sequenom, Inc.
Laboratory Corporation of America
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Arm 1 * All samples and data are de-identified and HIPAA compliant * Arm 2 * Subject is of scientific interest to the Sponsor or treating physician * Subject provides written informed consent and has a clinical sample and/or supporting clinical data collected.
Exclusion criteria
* Arm 1 * Subject is from a US state or a country where local law restricts the use of de-identified data and/or remnants of specimens for research and/or development * Arm 2 * Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remnant samples and data for research and development | Retrospective and Prospective collection. Samples and data may be collected for up 12 months after enrollment. | Remnant samples and data for research and development |
| Sample and data collection from subjects of scientific interest | Prospective collection. Samples and data may be collected for up to 12 months after enrollment | Collect additional clinical data and samples if needed from subjects tested by LabCorp or an affiliate. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGraham P McLennan
Sequenom, Inc.
Outcome results
None listed