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NCT02586389 | RECRUITING | Non-hematologic Cancer

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

Sequenom, Inc.

Brief 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).

Condition or disease

Non-hematologic Cancer

Detailed Description:

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).

Study Type : OBSERVATIONAL
Estimated Enrollment : 3000 participants
Official Title : 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
Actual Study Start Date : 2015-10-13
Estimated Primary Completion Date : 2027-10-31
Estimated Study Completion Date : 2027-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Specimen Collection from Patients with Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay

Location Details

NCT02586389

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Idaho

Idaho Urology

Boise, Idaho, United States,