Non-hematologic CancerNCT02586389
Specimen Collection From Patients With Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay
An observational study of Non-hematologic Cancer, run by Sequenom, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hematologic Cancer
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2015to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
- residual tumor tissue available for testing by the Sponsor; or
- genomic profiling results from an IVD or LDT assay performed on tumor biopsy tissue; or
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
- Conditions
- Non-hematologic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-hematological Cancer Cohort | Eligible subjects will have been previously diagnosed with a non-hematological cancer with tumor present at baseline blood draw. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After cancer diagnosis through 5 years of standard of care follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start13 Oct 2015
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hematologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sue Beruti, MD, Study director, Sequenom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586389
- Sponsor's protocol ID
- SQNM-CA-101
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2015
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02586389
- Acronym / sponsor ID
- SQNM-CA-101
- Conditions
- Non-hematologic Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-hematological Cancer Cohort | – | –Eligible subjects will have been previously diagnosed with a non-hematological cancer with tumor present at baseline blood draw. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
- Subject is able, in the professional opinion of the investigator, to provide whole blood at the Baseline Visit and at the Interim Visits.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biospecimen sample collection for liquid biopsy assay development
Time frame: After cancer diagnosis through 5 years of standard of care follow-up visits
Analysis of circulating tumor DNA (ctDNA) in whole blood will be compared to baseline tumor DNA for concordance of mutations related to cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sue Beruti, MD study director
Sequenom, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-hematologic Cancer, run by Sequenom, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Graham McLennan ((858) 202-9162, gmclennan@sequenom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.