Detection of Tumor DNA in Blood Samples From Cancer Patients

Detection of Tumor DNA in Blood Samples From Patients With Late Stage Cancer and Healthy Controls

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02288754

Enrollment

500

Registered

2014-11-11

Start date

2014-12-31

Completion date

2020-11-30

Last updated

2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Tumors

Keywords

DNA in Tumors, cfDNA, WGS, Advanced stage cancer, Solid tumors

Brief summary

The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.

Interventions

DIAGNOSTIC_TESTBlood test

No intervention except to collect blood for diagnostic test development

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Age 18 years or older * Have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage II or III solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery * Starting treatment or a new line of treatment * Able to understand and grant informed consent * Able to have their blood drawn

Exclusion criteria

* Unable to grant informed consent or comply with all study procedures. * Has a hematological malignancy, i.e. myeloma, lymphoma, MDS, leukemia

Design outcomes

Primary

Measure	Time frame	Description
Correlation between the tumor load score and patient response to therapies.	5 years	Determination of a direct correlation between the tumor load score and patient response to therapies.

Secondary

Measure	Time frame	Description
Determination of particular mutation events which underlie the basis of any established correlation with therapy response.	5 years	To determine which particular mutation events underlie the basis of any established correlation with therapy response.

Countries

United States

Contacts

Primary ContactHaluk Tezcan, MD

htezcan@lexentbio.com530-863-7922

Backup ContactAyse Z Tezcan, Ph.D.

atezcan@lexentbio.com530-863-7936

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026