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

NCT02586389 | Recruiting

• 1 other identifier: SQNM-CA-101
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-hematologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Non-hematological Cancer Cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• residual tumor tissue available for testing by the Sponsor; or
• genomic profiling results from an IVD or LDT assay performed on tumor biopsy tissue; or
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sequenom, Inc.: lead

Study Sites (1)

Idaho Urology

Boise, Idaho, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples and tissue samples will be collected for DNA extraction.

Study Officials

• Sue Beruti, MD

  Sequenom, Inc.

  STUDY DIRECTOR

Central Study Contacts

Graham McLennan

CONTACT

(858) 202-9162; gmclennan@sequenom.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 26, 2015
• Study Start: October 13, 2015
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

US (1)