Analysis of patient samples and data for research purposes
Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies And/or Population-based Analysis
Sequenom, Inc. · NCT04364503
This study is looking at leftover patient samples and data to see how they can help understand different health issues like pregnancy complications, cancer, and infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Sequenom, Inc. (industry) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT04364503 on ClinicalTrials.gov |
What this trial studies
This observational study involves the analysis of de-identified remnant samples and data from patients who have provided commercial samples to LabCorp or its affiliates. The study consists of two arms: the first utilizes existing de-identified samples for research and development, while the second involves collecting additional samples and data from patients who provide informed consent. The aim is to conduct population-based analyses and further research on various conditions, including pregnancy-related issues, cancer, and infectious diseases.
Who should consider this trial
Good fit: Ideal candidates include patients who have provided commercial samples and are of scientific interest to the sponsor or treating physician.
Not a fit: Patients who are unable to provide informed consent or are from jurisdictions with restrictions on the use of de-identified data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding and treatment options for pregnancy-related conditions, cancer, and infectious diseases.
How similar studies have performed: Other studies utilizing de-identified patient data for research have shown success, indicating that this approach is both viable and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California
- Sequenom, Inc — San Diego, California, United States (RECRUITING)
Study contacts
- Principal investigator: Graham P McLennan — Sequenom, Inc.
- Study coordinator: Graham P Senior Director
- Email: mclenng@labcorp.com
- Phone: (858) 202-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy Related, Cancer, Infectious Disease