Collecting blood and tissue samples from cancer patients for a new liquid biopsy test
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
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 |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sequenom, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boise, Idaho) |
| Trial ID | NCT02586389 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of non-hematologic cancer who have available tumor tissue for testing.
Not a fit: Patients who have undergone curative-intent surgery or certain therapies prior to the baseline visit may not benefit from this study.
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 performed: Other studies have shown promise in developing liquid biopsy assays, indicating that this approach has potential based on previous successes.
Eligibility criteria
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 this trial is running
Boise, Idaho
- Idaho Urology — Boise, Idaho, United States (Recruiting)
Study contacts
- Study coordinator: Graham McLennan
- Email: gmclennan@sequenom.com
- Phone: (858) 202-9162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.