Compliant Analysis of Patient Samples and Data

Recruiting

• Conditions: Pregnancy Related; Infectious Disease; Cancer

• Registration Number: NCT04364503
• Lead Sponsor: Sequenom, Inc.

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.

Study Timeline

• Study Start: 2018-03-17
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16
• Primary Completion: 2030-03-17
• Study Completion: 2030-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Sequenom, Inc; 🇺🇸 San Diego, California, United States