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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:9/29/2017
Start Date:June 30, 2017
End Date:April 2022
Contact:Haluk Tezcan, MD
Email:htezcan@lexentbio.com
Phone:5308637922

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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 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.

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).
We found this trial at
1
site
9850 Genesee Avenue
La Jolla, California 92121
Principal Investigator: Mark Sherman, MD
Phone: 530-863-7922
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from
La Jolla, CA
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