Compliant Analysis of Patient Samples and Data
Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies And/or Population-based Analysis
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 17, 2018
CompletedFirst Submitted
Initial submission to the registry
April 22, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2030
October 16, 2024
October 1, 2024
12 years
April 22, 2020
October 11, 2024
Conditions
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
Remnant samples and corresponding data from multiple diagnostic tests will be stored for future research and development.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
- Laboratory Corporation of Americacollaborator
Study Sites (1)
Sequenom, Inc
San Diego, California, 92121, United States
Biospecimen
Commercial remnant samples stored at multiple LabCorp affiliates.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Graham P McLennan
Sequenom, Inc.
Central Study Contacts
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
October 16, 2024
Record last verified: 2024-10