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

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

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).

Study Overview

• Status: Recruiting
• Conditions: 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
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Graham McLennan; Phone Number: (858) 202-9162; Email: gmclennan@sequenom.com

Study Locations

• United States
  • California
    • Riverside, California, United States, 92501
      • Recruiting
      • Compassionate Care Research Group, Inc.
      • Contact: Corina King, CCRP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Non-hematological Cancer Cohort; Eligible subjects will have been previously diagnosed with a non-hematological cancer with tumor present at baseline blood draw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sequenom, Inc.
• Investigators: Study Director: Sue Beruti, MD, Sequenom, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimated): October 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SQNM-CA-101