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

Terminated

• Conditions: Neoplasms, Non-hematologic - Stage I-III

• Registration Number: NCT03071809
• Lead Sponsor: Lexent Bio, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-07
• Study Start: 2017-06-30
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of signal in the presence of active neoplasm	2 years	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.
Determine change in signal after surgery	5 years	To determine the response of tumor load score as a function of tumor presence as determined pre- and post-surgery intended to be curative

Trial Locations

Locations (1)

Alisa Williams, MD Inc; 🇺🇸 San Diego, California, United States