Compliant Analysis of Patient Samples and Data

N/AEnrolling By InvitationNCT04364503

Sequenom, Inc.2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Interventions

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (9)

Labcorp

Los Angeles, California, United States

Sequenom, Inc

San Diego, California, United States

Labcorp - Monogram Biosciences

South San Francisco, California, United States

Labcorp - Esoterix

Englewood, Colorado, United States

Outcomes

Primary Outcomes

Remnant samples and data for research and development

Time frame: 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.

Time frame: Prospective collection. Samples and data may be collected for up to 12 months after enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.