Compliant Analysis of Patient Samples and Data

NCT04364503 | Enrolling By Invitation

• 1 other identifier: SCMM-RND-402
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 9

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.

Conditions

Pregnancy Related; Cancer; Infectious Disease

Outcome Measures

Primary Outcomes (2)

• 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.

• 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

Interventions

Multiple interventions depending on diagnostic test being run. DEVICE

Remnant samples and corresponding data from multiple diagnostic tests will be stored for future research and development.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sequenom, Inc.: lead
• Laboratory Corporation of America: collaborator

Study Sites (9)

Labcorp

Los Angeles, California, 90064, United States

Location

Sequenom, Inc

San Diego, California, 92121, United States

Location

Labcorp - Monogram Biosciences

South San Francisco, California, 94080, United States

Location

Labcorp - Esoterix

Englewood, Colorado, 80112, United States

Location

Labcorp - Litholink

Itasca, Illinois, 60143, United States

Location

Labcorp - Omniseq

Buffalo, New York, 14203, United States

Location

Labcorp

Burlington, North Carolina, 27215, United States

Location

Labcorp - Cytogenetics

Research Triangle Park, North Carolina, 27709, United States

Location

Labcorp

Research Triangle Park, North Carolina, 27709, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Commercial remnant samples stored at multiple LabCorp affiliates.

MeSH Terms

Conditions

Neoplasms; Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Graham P McLennan

  Sequenom, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 28, 2020
• Study Start: March 17, 2018
• Primary Completion (Estimated): March 17, 2030
• Study Completion (Estimated): August 15, 2030
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

US (9)