Compliant Analysis of Patient Samples and Data

S

Sequenom

Status

Enrolling

Conditions

Pregnancy Related
Infectious Disease
Cancer

Treatments

Device: Multiple interventions depending on diagnostic test being run.

Study type

Observational

Funder types

Industry

Identifiers

NCT04364503
SCMM-RND-402

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

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Central trial contact

Graham P Senior Director

Data sourced from clinicaltrials.gov

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