Recruiting

Liquid Biopsy

Sponsor:

Sequenom, Inc.

Code:

NCT02586389

Conditions

Non-hematologic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02586389

Start date

Oct 13, 2015

Status verified date

Oct, 2024

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • biospecimen sample collection for liquid biopsy assay development [ Time Frame: After cancer diagnosis through 5 years of standard of care follow-up visits ]

Central Contacts and Locations

Central contacts

Locations

Idaho Urology

Recruiting

Boise, Idaho, United States

More Information

Sponsor

Sequenom, Inc.

Last update posted

Oct 16, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sequenom, Inc. on 2024-10-16.