Clinical Trials in the USA / NCT02586389
Recruiting
Observational
Specimen Collection From Patients With Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay
NCT02586389 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Non-hematologic Cancer
Study 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
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.
Primary outcome measure(s)
- biospecimen sample collection for liquid biopsy assay development — After cancer diagnosis through 5 years of standard of care follow-up visits
Analysis of circulating tumor DNA (ctDNA) in whole blood will be compared to baseline tumor DNA for concordance of mutations related to cancer.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Idaho Urology | Boise | Idaho | Recruiting |
More Sequenom, Inc. trials in the USA
Compliant Analysis of Patient Samples and Data
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02586389 on ClinicalTrials.gov ↗ ← All trials in the USA