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"

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Tumors
• Intervention / Treatment: Diagnostic test: Blood test

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90277
      • Recruiting
      • Cancer Care Associates
      • Contact: David Chan, MD; Phone Number: 310-750-3300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are (i) commencing or (ii) starting a new line of treatment for metastatic disease with any cytotoxic chemotherapy, targeted therapy, immunotherapy, a combination of any and/or radiation therapy. Patients with stage II or III solid tumors undergoing curative intend surgery or neoadjuvant therapy followed by surgery are also eligible, before surgery or initiation of neoadjuvant therapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stage II or III curative surgery (closed to accrual); Patients with stage II or III solid tumors undergoing curative intend surgery enrolled before surgery.	Diagnostic test: Blood test; No intervention except to collect blood for diagnostic test development
Stage II or III neoadjuvant therapy cohort (closed to accrual); Patients with stage II or III solid tumors undergoing neoadjuvant therapy followed by curative intend surgery enrolled before neoadjuvant therapy.	Diagnostic test: Blood test; No intervention except to collect blood for diagnostic test development
Metastatic disease; Patients with advanced, recurrent and/or metastatic disease requiring systemic therapy with chemotherapy, targeted therapy, immunotherapy or a combination of any before initiation of any therapy or a new line of therapy following documentation of disease progression on prior therapy.	Diagnostic test: Blood test; No intervention except to collect blood for diagnostic test development

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lexent Bio, Inc.
• Investigators: Principal Investigator: Haluk Tezcan, MD, Lexent Bio

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Solid tumors; cfDNA; WGS; DNA in Tumors; Advanced stage cancer
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LB1985106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No