Clinical trial NCT02586389: Specimen Collection from Patients with Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay
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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-hematologic Cancer
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

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).

Eligibility 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.

Primary outcomes:
measure: biospecimen sample collection for liquid biopsy assay development
timeFrame: After cancer diagnosis through 5 years of standard of care follow-up visits
Secondary outcomes:
Other outcomes:
Locations:
city: Boise
country: United States
facility: Idaho Urology
state: Idaho
Study officials:
affiliation: Sequenom, Inc.
name: Sue Beruti, MD
role: STUDY_DIRECTOR
References: