Detection of Tumor DNA in Blood Samples From Cancer Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02288754
• Other study ID #: LB1985106
• Status: Recruiting
• Start date: December 2014
• Est. completion date: November 2020

Study information

• Verified date: August 2019
• Source: Lexent Bio, Inc.
• Contact: Haluk Tezcan, MD
• Phone: 530-863-7922
• Email: htezcan[@]lexentbio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Tumors

Intervention

Diagnostic Test:
• Blood test
No intervention except to collect blood for diagnostic test development

Locations

Country	Name	City	State
United States	Cancer Care Associates	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Lexent Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the tumor load score and patient response to therapies.	Determination of a direct correlation between the tumor load score and patient response to therapies.	5 years
Secondary	Determination of particular mutation events which underlie the basis of any established correlation with therapy response.	To determine which particular mutation events underlie the basis of any established correlation with therapy response.	5 years