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

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ClinicalTrials.gov Identifier: NCT02586389
Recruitment Status : Recruiting
First Posted : October 26, 2015
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Sequenom, Inc.

Study Description
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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 Design
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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 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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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.


Outcome Measures
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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.

Eligibility Criteria
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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.
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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02586389


Contacts
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Contact: Graham McLennan (858) 202-9162 gmclennan@sequenom.com

Locations
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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.
Investigators
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Study Director: Sue Beruti, MD Sequenom, Inc.
More Information
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Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT02586389    
Other Study ID Numbers: SQNM-CA-101
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023