ClinicalTrials.gg
RecruitingNCT02586389Updated Oct 2, 2026

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

An observational study in Non-hematologic Cancer, sponsored by Sequenom, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Sequenom, Inc. (part of Labcorp) · Observational

From the registry’s dates

  • Started Oct 2015; still recruiting 11 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Non-hematologic Cancer
03

In context

Lead sponsor

Sequenom, Inc. is the lead sponsor of 26 studies on the registry; 5 are open to participants now.

First submitted before Sequenom, Inc. became part of Labcorp.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is 18 years of age or older;
  • Subject is willing to provide written ;
  • 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 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

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 (, 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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Non-hematological Cancer Cohort

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

06

What researchers measure

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.

    Time frame: After cancer diagnosis through 5 years of standard of care follow-up visits

07

Study locations

1 of 1 sites recruiting
  • Idaho Urology
    Boise, Idaho, United States
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: identifiers and verification date
1 update, last Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Minor edits only
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT02586389
Lead sponsor
Sequenom, Inc.
Responsible party
Sponsor
First posted
Oct 26, 2015
Start date
Oct 13, 2015
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

Graham McLennan
Contact
gmclennan@sequenom.com
(858) 202-9162
Sue Beruti, MD
study director · Sequenom, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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