Specimen Collection From Patients With Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay

Non-hematologic Cancer Clinical Trial

Official title:

Collection of Whole Blood and Tissue Specimens From Patients Diagnosed With Non-Hematologic Cancer for Use in Development of a Noninvasive Liquid Biopsy Assay to Determine the Tumor Genomic Profile in Circulating Cell-Free Tumor DNA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02586389
• Other study ID #: SQNM-CA-101
• Status: Recruiting
• Start date: October 2015
• Est. completion date: October 2025

Study information

• Verified date: August 2023
• Source: Sequenom, Inc.
• Contact: Graham McLennan
• Phone: (858) 202-9162
• Email: gmclennan[@]sequenom.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).

Description:

This is a non-significant risk multicenter, longitudinal specimen collection study. At the Baseline Visit, whole blood will be collected to be paired with either a previously collected tumor biopsy tissue sample or a prospectively collected tumor tissue sample. Whole blood samples will also be collected longitudinally at Interim visits for up to 5 years. Interim visits will be on a schedule dictated by their physician's standard-of-care management protocol. No more than 100mL of blood will be collected per month. Tumor tissue from recurrences will be collected for the duration of subject participation (after the Baseline Visit).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is 18 years of age or older;
• Subject is willing to provide written informed consent;
• Subject has a diagnosis of a non-hematologic cancer, has tumor in the body, and has either;

1. residual tumor tissue available for testing by the Sponsor; or

2. genomic profiling results from an IVD or LDT assay performed on tumor biopsy tissue; or

3. an invasive procedure (biopsy, surgery) scheduled following the Baseline Visit from which residual tumor tissue can be available for testing by the Sponsor.

• Subject is able, in the professional opinion of the investigator, to provide whole blood at the Baseline Visit and at the Interim Visits.

Exclusion Criteria:

• Underwent curative-intent surgery for management of the presently diagnosed tumor, at any time prior to the Baseline Visit.
• Underwent targeted or non-targeted chemotherapy, hormone receptor blocking therapy, or radiation therapy prior to the Baseline Visit.
• Underwent an invasive procedure (biopsy, surgery, thermal ablation) in the 7 days prior to any blood collection (baseline or follow-up).
• Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.

Related Conditions & MeSH terms

• Non-hematologic Cancer

Locations

Country	Name	City	State
United States	Compassionate Care Research Group, Inc.	Riverside	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	biospecimen sample collection for liquid biopsy assay development	Analysis of circulating tumor DNA (ctDNA) in whole blood will be compared to baseline tumor DNA for concordance of mutations related to cancer.	After cancer diagnosis through 5 years of standard of care follow-up visits