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

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.

Conditions2

Locations1 site

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