Clinical trial NCT03746262: Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer
Official title: A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Non-Metastatic Non-Small Cell Lung Cancer
Cancer
Lung Cancer
circulating tumor-specific DNA (ctDNA)
non-invasive diagnostic
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Guardant Health, Inc.
name: National Cancer Institute (NCI)
First posted: 2018-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.

Brief summary: The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment.

Detailed description: The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment. The total amount of blood withdrawn during the study will be approximately 9 teaspoons. Participants will be followed every 3 months for 12 months to determine if a confirmed recurrence or progression has occurred. Participants will also be asked to complete questionnaires on their quality of life and their smoking behaviors. As part of this study, a blood sample will be obtained and DNA from participants blood sample will be purified. DNA, or deoxyribonucleic acid, stores and transmits inherited traits, such as eye color or blood type. As part of this research project, participant's DNA will be studied in an effort to find out if there are genes that contribute to medical conditions like their cancer that are part of the study. If participants have surgery to have tumor removed or if participants have a biopsy of their tumor, the study would like to take some of the leftover tissue to purify and study the DNA from the tissue sample.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed or clinically suspected stage I, II or III NSCLC, provided such patients will be scheduled for a procedure that will provide histologic confirmation of the diagnosis (if the procedure does not provide histologic confirmation of the diagnosis of NSCLC the particular patient will be removed from the study and replaced).
* Scheduled for treatment with surgery or radiotherapy (Stage I), surgery and chemotherapy (Stage II), or chemoradiotherapy (Stage III). For stage I receiving radiotherapy, treatment must be stereotactic body radiation therapy (SBRT) consisting of 3-5 fractions.
* Ability to provide blood sample at the following time points: pre-treatment, 1 month post definitive treatment, and 4 post definitive treatment.
* Ability to understand and the willingness to sign an IRB-approved informed consent document.
* Staging studies including PET-CT for all patients prior to the initiation of primary treatment, as a pretreatment requirement. For patients with Stage II and III, MRI or CT of the brain is needed prior to the initiation of primary treatment. Patients, however, may be registered and have the pretreatment blood sample collected, provided that the staging studies are being scheduled. Registered patients who are found, after screening tests, to have Stage IV disease will be removed from the study and replaced.

Exclusion Criteria:

* Females who are pregnant
* History of organ transplant.
* For stage II and III patients, must be able to receive chemotherapy.
* Active cardiovascular issues in the past 6 months.

Primary outcomes:
measure: Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC
timeFrame: up to 12 months
measure: Change in ctDNA levels in patients with Stage III NSCLC
timeFrame: up to 12 months
measure: Change in ctDNA by treatment group
timeFrame: up to 12 months
Secondary outcomes:
measure: Health Related Quality of Life- (HRQL)
timeFrame: up to 12 months
measure: Number of Packs Smoked Per Day
timeFrame: up to 12 months
measure: Number of Years Smoked
timeFrame: up to 12 months
measure: Number of Participants that have a Smoking Status
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stefan Grant, MD
role: PRINCIPAL_INVESTIGATOR
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