Compliant Analysis of Patient Samples and Data

Cancer Clinical Trial

Official title:

Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies and/or Population-based Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364503
• Other study ID #: SCMM-RND-402
• Status: Recruiting
• Start date: March 17, 2018
• Est. completion date: August 15, 2025

Study information

• Verified date: August 2023
• Source: Sequenom, Inc.
• Contact: Graham P Senior Director
• Phone: (858) 202-2000
• Email: mclenng[@]labcorp.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 15, 2025
• Est. primary completion date: March 17, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Communicable Diseases
• Infections
• Infectious Disease
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
United States	Sequenom, Inc	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sequenom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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