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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04364503
Other study ID # SCMM-RND-402
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 17, 2018
Est. completion date August 15, 2025

Study information

Verified date August 2023
Source Sequenom, Inc.
Contact Graham P Senior Director
Phone (858) 202-2000
Email mclenng@labcorp.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date August 15, 2025
Est. primary completion date March 17, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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


Intervention

Device:
Multiple interventions depending on diagnostic test being run.
Remnant samples and corresponding data from multiple diagnostic tests will be stored for future research and development.

Locations

Country Name City State
United States Sequenom, Inc San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Sequenom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Remnant samples and data for research and development Remnant samples and data for research and development Retrospective and Prospective collection. Samples and data may be collected for up 12 months after enrollment.
Primary 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. Prospective collection. Samples and data may be collected for up to 12 months after enrollment
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