ClinicalTrials.gg
Enrolling by invitationNCT04364503Updated Jul 21, 2026

Compliant Analysis of Patient Samples and Data

An observational study in Pregnancy Related, Cancer and Infectious Disease, sponsored by Sequenom, Inc.. Enrolling by invitation at 9 sites in United States. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Sequenom, Inc. (part of Labcorp) · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy Related
  • Cancer
  • Infectious Disease
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Sequenom, Inc. is the lead sponsor of 26 studies on the registry; 5 are open to participants now.

First submitted after Sequenom, Inc. became part of Labcorp.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and has a clinical sample and/or supporting clinical data collected.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • DeviceMultiple interventions depending on diagnostic test being run.

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

06

What researchers measure

Primary outcomes

  1. Remnant samples and data for research and development

    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.

  2. 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.

    Time frame: Prospective collection. Samples and data may be collected for up to 12 months after enrollment

07

Study locations

9 sites
  • Labcorp
    Los Angeles, California 90064, United States
  • Sequenom, Inc
    San Diego, California 92121, United States
  • Labcorp - Monogram Biosciences
    South San Francisco, California 94080, United States
  • Labcorp - Esoterix
    Englewood, Colorado 80112, United States
  • Labcorp - Litholink
    Itasca, Illinois 60143, United States
  • Labcorp - Omniseq
    Buffalo, New York 14203, United States
  • Labcorp
    Burlington, North Carolina 27215, United States
  • Labcorp - Cytogenetics
    Research Triangle Park, North Carolina 27709, United States
  • Labcorp
    Research Triangle Park, North Carolina 27709, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04364503
Lead sponsor
Sequenom, Inc.
Collaborators
Laboratory Corporation of America
Responsible party
Sponsor
First posted
Apr 28, 2020
Start date
Mar 17, 2018
Primary completion
Mar 17, 2030 (estimated)
Completion
Aug 15, 2030 (estimated)
Last update
Jul 21, 2026

Study contacts

Graham P McLennan
principal investigator · Sequenom, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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No contact was published for this record. The registry link below has the sponsor’s details.

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