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

The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators 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: Terminated
• Conditions: Neoplasms, Non-hematologic - Stage I-III

Detailed Description

The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.

The presence of circulating tumor-derived cfDNA in the plasma of patients can potentially enable a non-invasive means of detecting the presence or absence of tumor, assessing tumor burden and characterizing tumor biology in patients with cancer. The ability to measure the distribution of circulating tumor DNA may allow determination of a quantitative tumor load score in plasma that correlates to clinical tumor load. Clinical tumor load is a measure of disease burden, and the investigators propose to test in this study whether the tumor load score can measure this disease burden. A simple, reliable measure of disease burden would have diverse utility during patient therapy.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • Alisa Williams, MD Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Up to 200 patients from multiple clinical sites will be enrolled in this study. Patients are eligible for this study if they are diagnosed with a solid tumor and undergoing curative resection. In addition, up to 200 participants with no prior or current diagnosis of cancer will be enrolled as a control group, i.e. "healthy control," for assay development.

Description

Inclusion Criteria:

1. For all participants:

• Age 18 years or older
• Able to understand and grant informed consent
• Able to have their blood drawn at enrollment before surgery and 7 to 28 days after surgery

For participants with early stage solid tumors:

• Diagnosed with an early stage (I-III) solid tumor with curative intent surgery without neoadjuvant therapy planned

For "healthy control" subgroup:

• No prior or current diagnosis of any cancer. Participants with prior in situ cancer or non-melanoma skin cancer will be allowed to participate but will not be included in the "healthy control" cohort and will be analyzed separately.

Exclusion Criteria:

• Unable to grant informed consent or comply with all study procedures
• Diagnosed with a hematological malignancy (acute or chronic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myeloma or lymphoma).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Early stage neoplasm; Patients with stage I-III early stage non-hematologic neoplasm
Healthy Control; Patients undergoing surgery for a non-malignant condition with no prior history of malignancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of signal in the presence of active neoplasm	To determine the association between the tumor load score and clinical tumor load as assessed with the current standard of care methods and pathology findings.	2 years
Determine change in signal after surgery	To determine the response of tumor load score as a function of tumor presence as determined pre- and post-surgery intended to be curative	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 (Actual): June 30, 2017
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 7, 2017

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: carcinoma; stage III; Solid tumor; sarcoma; stage I; stage II
• Other Study ID Numbers: LB-2017-03-01

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