Compliant Analysis of Patient Samples and Data
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multiple interventions depending on diagnostic test being run..
- Who it may be relevant to
- Registry conditions: Pregnancy Related, Cancer, Infectious Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies and/or Population-based Analysis
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- 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.]
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- Labcorp — Los Angeles
- Sequenom, Inc — San Diego
- Labcorp - Monogram Biosciences — South San Francisco
- Labcorp - Esoterix — Englewood
- Labcorp - Litholink — Itasca
- Labcorp - Omniseq — Buffalo
- Labcorp — Burlington
- Labcorp - Cytogenetics — Research Triangle Park
- … and 1 more center
Identifiers
NCT: NCT04364503 · SCMM-RND-402