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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.

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).

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : October 2015
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
Whole blood samples and tissue samples will be collected for DNA extraction.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02586389

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Contact: Graham McLennan (858) 202-9162

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United States, California
Compassionate Care Research Group, Inc. Recruiting
Riverside, California, United States, 92501
Contact: Corina King, CCRP         
Sponsors and Collaborators
Sequenom, Inc.
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Study Director: Sue Beruti, MD Sequenom, Inc.
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Responsible Party: Sequenom, Inc. Identifier: NCT02586389    
Other Study ID Numbers: SQNM-CA-101
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021