Collecting blood and tissue samples from cancer patients for a new liquid biopsy test
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
Run by Sequenom, Inc. · NCT02586389 · Data updated 2026-11-12
This study is collecting blood and tissue samples from cancer patients to see if a new noninvasive test can help improve cancer diagnosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Sequenom, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boise, Idaho) |
| Status | Recruiting |
| Started | October 13, 2015 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT02586389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a diagnosis of non-hematologic cancer who have available tumor tissue for testing.
✕Probably not a fit
Patients who have undergone curative-intent surgery or certain therapies prior to the baseline visit may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to collect whole blood and tumor tissue from patients diagnosed with non-hematologic cancer to develop a noninvasive liquid biopsy assay using next generation sequencing (NGS). Participants will provide blood samples at baseline and during interim visits over a period of up to five years, with tumor tissue collected from recurrences as needed. The study is designed to gather essential specimens that will aid in the advancement of liquid biopsy technology for cancer diagnostics.
Why it matters
Potential benefit: If successful, this study could lead to the development of a less invasive method for cancer diagnosis and monitoring.
How similar studies have gone: Other studies have shown promise in developing liquid biopsy assays, indicating that this approach has potential based on previous successes.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Idaho Urology
Boise, Idaho, United States Recruiting
Study contacts
- Study coordinator: Graham McLennan
- Email: gmclennan@sequenom.com
- Phone: (858) 202-9162
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Virtual reality to improve comfort for adults with hematologic cancer in hospital
Researchers are testing whether short VR experiences can help comfort and mood for adults with blood cancers who are staying in the hospital for at least 15 days.
-
Genetics of Blood Cancers in the U.S. population
This study tests how genetic factors relate to blood cancers by collecting saliva DNA and online health surveys from at least 10,000 U.S. adults.
-
Venetoclax added to reduced-intensity conditioning for combined stem cell and kidney transplant
This trial tests whether adding venetoclax to a reduced-intensity conditioning regimen is safe for adults with blood cancers who are receiving a combined stem cell and kidney transplant from a matched or partially matched donor.
-
Using exercise and nutrition to reduce CAR‑T neurotoxicity in adults with blood cancers
This test will try whether a structured exercise program alone or combined with nutrition advice can lower the risk or severity of neurotoxicity after CAR‑T therapy in adults (18–80) with hematologic cancer.
-
Florida ASCENT Program
This project will test whether combining the MyCarePulse EHR platform with ASCENT patient navigators helps adults with recent cancer diagnoses in Florida improve food security, diet quality, and confidence in healthy eating compared with standard care.
-
18F-G1 PET/CT to see early immunotherapy response in solid tumors and blood cancers
We are testing if the 18F-G1 PET/CT scan can help tell early on whether people with solid tumors or blood cancers will respond to immunotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.