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OpenTrials
Enrolling by Invitation

NCT Number: NCT04364503

Compliant Analysis of Patient Samples and Data

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.

Enrolling by Invitation

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Labcorp, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Remnant samples and data for research and development

  2. Sample and data collection from subjects of scientific interest

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Collaborators

  • Laboratory Corporation of America

Registry information

Official study title

Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies and/or Population-based Analysis

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Apr 28, 2020
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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