Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-hematological Cancer Cohort | Eligible subjects will have been previously diagnosed with a non-hematological cancer with tumor present at baseline blood draw. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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;
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:
Not provided
Not provided
Not provided
Male or female patients at least 18 years of age who have been diagnosed with non-hematologic cancer (Stages I-IV) and who meet all study inclusion criteria and no exclusion criteria. Primarily subjects with breast, colorectal, lung, or melanoma cancer (90%) will be enrolled. The remaining subjects (10%) diagnosed with other cancer types may be enrolled on a case by case basis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Graham McLennan | Contact | (858) 202-9162 | gmclennan@sequenom.com |
| Name | Affiliation | Role |
|---|---|---|
| Sue Beruti, MD | Sequenom, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Idaho Urology | Recruiting | Boise | Idaho | United States |
Not provided
Not provided
Not provided
Not provided
Whole blood samples and tissue samples will be collected for DNA extraction.