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

Last updated: October 11, 2024
Sponsor: Sequenom, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02586389
SQNM-CA-101
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 haseither;

  1. residual tumor tissue available for testing by the Sponsor; or

  2. genomic profiling results from an IVD or LDT assay performed on tumor biopsytissue; or

  3. an invasive procedure (biopsy, surgery) scheduled following the Baseline Visitfrom which residual tumor tissue can be available for testing by the Sponsor.

  • Subject is able, in the professional opinion of the investigator, to provide wholeblood at the Baseline Visit and at the Interim Visits.

Exclusion

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 daysprior to any blood collection (baseline or follow-up).

  • Any medical or mental condition that would interfere with the subjects' ability towillingly give written informed consent.

Study Design

Total Participants: 3000
Study Start date:
October 13, 2015
Estimated Completion Date:
October 31, 2027

Study 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).

Connect with a study center

  • Compassionate Care Research Group, Inc.

    Riverside, California 92501
    United States

    Site Not Available

  • Idaho Urology

    Boise, Idaho
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.