Compliant Analysis of Patient Samples and Data

October 11, 2024 updated by: Sequenom, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Recruiting
        • Sequenom, Inc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Arm 1 - Female or male patient samples submitted to Sequenom or LabCorp affiliate for routine clinical care testing that no longer need to be maintained for clinical purposes.

Arm 2 - Female or male subjects of scientific interest who have provided written informed consent/assent.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
Prospective collection. Samples and data may be collected for up to 12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequenom, Inc.

Collaborators

Laboratory Corporation of America

Investigators

  • Principal Investigator: Graham P McLennan, Sequenom, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2018

Primary Completion (Estimated)

March 17, 2030

Study Completion (Estimated)

August 15, 2030

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMM-RND-402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe