Compliant Analysis of Patient Samples and Data

NCT ID: NCT04364503

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-17

Study Completion Date

2030-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related Cancer Infectious Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratory Corporation of America

INDUSTRY

Sponsor Role collaborator

Sequenom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Graham P McLennan

Role: PRINCIPAL_INVESTIGATOR

Sequenom, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sequenom, Inc

San Diego, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Graham P Senior Director

Role: CONTACT

(858) 202-2000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Graham P McLennan, MS

Role: primary

(858) 202-2000

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCMM-RND-402

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Carbon Monoxide Blood and DNA Biorepository
NCT01758653 ENROLLING_BY_INVITATION