RecruitingNCT02586389
Specimen Collection from Patients with Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay
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
Sponsor
Sequenom, Inc.
Enrollment
3,000 participants
Start Date
Oct 13, 2015
Study Type
OBSERVATIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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;
- residual tumor tissue available for testing by the Sponsor; or
- genomic profiling results from an IVD or LDT assay performed on tumor biopsy tissue; or
- 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 Criteria4
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02586389