New Open Clinical Trial: The Circulating Cell-free Genome Atlas (CCGA) Study (GRAIL-001) NCT02889978
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- New diagnosis of histologically confirmed cancer present in the patient (any stage IIV, as well as carcinoma in situ (CIS)), across multiple tumor types (see Appendix A) with no prior systemic cancer therapy and scheduled for surgical resection or nonsurgical management
- Or, Subjects with a high suspicion for cancer diagnosis by clinical and radiological assessment, but without preceding histologic diagnosis, are eligible, if they have not received prior systemic cancer therapy and are scheduled for surgery
- Has or will have a medically obtained pathological tumor specimen from core needle or surgical biopsy or removal of a metastatic mass or node within 90 days prior to study blood draw and/or planned surgical resection within 4 weeks (28 days) after study blood draw and pre-treatment
- At least one guideline recommended cancer screening test documented in the medical record and performed within the timeframe indicated for age and gender as described in Appendix B; (eg, pap smear, mammography, and/or colonoscopy)
- Prior diagnosis of cancer except: non-melanomatous skin cancer
- Pregnancy (by self-report of pregnancy status)
- Current febrile illness or active inflammatory disease
- Poor health status or unfit to tolerate blood draw, as determined by the investigator
The study test(s) to be used in this protocol are next generation sequencing (NGS)-based assay(s) that are under development and investigation by the sponsor. Nucleic acids (NAs) isolated from biospecimens collected and stored in this protocol (blood components and tumor tissue) will be sequenced and analyzed. Blood components include, but are not limited to, cell-free nucleic acids (cfNAs) from plasma and NAs isolated from platelets, white blood cells, and exosomes. NGS of formalin-fixed, paraffin embedded (FFPE) tumor specimens.