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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02586389
Recruitment Status : Recruiting
First Posted : October 26, 2015
Last Update Posted : September 20, 2021
Information provided by (Responsible Party):
Sequenom, Inc.

Tracking Information
First Submitted Date October 21, 2015
First Posted Date October 26, 2015
Last Update Posted Date September 20, 2021
Study Start Date October 2015
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2015)
biospecimen sample collection for liquid biopsy assay development [ Time Frame: After cancer diagnosis through 5 years of standard of care follow-up visits ]
Analysis of circulating tumor DNA (ctDNA) in whole blood will be compared to baseline tumor DNA for concordance of mutations related to cancer.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Specimen Collection From Patients With Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay
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
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).
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Whole blood samples and tissue samples will be collected for DNA extraction.
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.
Condition Non-hematologic Cancer
Intervention Not Provided
Study Groups/Cohorts Non-hematological Cancer Cohort
Eligible subjects will have been previously diagnosed with a non-hematological cancer with tumor present at baseline blood draw.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 22, 2015)
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Graham McLennan (858) 202-9162
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02586389
Other Study ID Numbers SQNM-CA-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sequenom, Inc.
Study Sponsor Sequenom, Inc.
Collaborators Not Provided
Study Director: Sue Beruti, MD Sequenom, Inc.
PRS Account Sequenom, Inc.
Verification Date September 2021