Clinical trial NCT03071809: Detection of Tumor DNA in Blood Samples From Patients With Early Stage Cancer and "Healthy Controls"
Official title: Detection of Tumor DNA in Blood Samples From Patients With Early Stage Cancer and "Healthy Controls"
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neoplasms, Non-hematologic - Stage I-III
Keywords: Solid tumor
carcinoma
sarcoma
stage I
stage II
stage III
Lead sponsor: Lexent Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Detection of signal in the presence of active neoplasm
timeFrame: 2 years
measure: Determine change in signal after surgery
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Alisa Williams, MD Inc
state: California
Study officials:
affiliation: Lexent Bio
name: Haluk Tezcan, MD
role: PRINCIPAL_INVESTIGATOR
References: