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

NCT ID: NCT03071809

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2019-03-15

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.

Conditions

Neoplasms, Non-hematologic - Stage I-III

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Early stage neoplasm

Patients with stage I-III early stage non-hematologic neoplasm

No interventions assigned to this group

Healthy Control

Patients undergoing surgery for a non-malignant condition with no prior history of malignancy.

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lexent Bio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haluk Tezcan, MD

Role: PRINCIPAL_INVESTIGATOR

Lexent Bio

Locations

Alisa Williams, MD Inc

San Diego, California, United States

Countries

United States

Other Identifiers

LB-2017-03-01

Identifier Type: -

Identifier Source: org_study_id