Pregnancy RelatedNCT04364503
Compliant Analysis of Patient Samples and Data
An observational study of Pregnancy Related and Cancer, run by Sequenom, Inc. at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Cancer, Infectious Disease
- What is being tested?
- Multiple interventions depending on diagnostic test being run.
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 Mar 2018to 15 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Labcorp - Omniseq
Buffalo, New York, 14203
Labcorp
Burlington, North Carolina, 27215
Labcorp - Esoterix
Englewood, Colorado, 80112
Labcorp - Litholink
Itasca, Illinois, 60143
Labcorp
Los Angeles, California, 90064
Labcorp - Cytogenetics
Research Triangle Park, North Carolina, 27709
Labcorp
Research Triangle Park, North Carolina, 27709
Sequenom, Inc
San Diego, California, 92121
Labcorp - Monogram Biosciences
South San Francisco, California, 94080
About this study
Official title: 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.
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.
- Conditions
- Pregnancy Related, Cancer, Infectious Disease
- Being tested
- Multiple interventions depending on diagnostic test being run.
- Medical subject headings
- Neoplasms, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Remnant samples and data for research and development
Remnant samples and data for research and development
Measured: 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.
Measured: Prospective collection. Samples and data may be collected for up to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start17 Mar 2018
- Primary completion17 Mar 2030 (estimated)
- Study completion15 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Graham P McLennan, Principal investigator, Sequenom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364503
- Sponsor's protocol ID
- SCMM-RND-402
- Status last verified
- Jul 2026
- First submitted
- 22 Apr 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies and/or Population-based Analysis
- ClinicalTrials.gov ID
- NCT04364503
- Acronym / sponsor ID
- SCMM-RND-402
- Conditions
- Pregnancy Related, Cancer, Infectious Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Study start
- 17 Mar 2018 (actual)
- Primary completion
- 17 Mar 2030 (estimated)
- Study completion
- 15 Aug 2030 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Graham P McLennan principal investigator
Sequenom, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Cancer, run by Sequenom, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.