Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Circulating Tumor Cells (CTC) in Lung Cancer

Summary: The primary objective of this study is to establish circulating tumor cell (CTC) derived xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples (personalize DNA repair therapy).

Detailed description: There are 3 cohorts for this study. Cohort A & Cohort B are for patient subjects. Patients can participate in both cohorts simultaneously, or only one cohort per patient preference.
  The investigators anticipate that most patients who participate in Cohort B will also participate in Cohort A because Cohort A only requires a one-time blood draw at baseline. Cohort C is for healthy volunteers. The purpose of recruiting health volunteers is purely for testing of the CTC chip system as the investigators routinely spike (inject) tumor cell lines in healthy human blood to ensure optimal CTC yield (quality control).
  Cohort A: 20 patients with NSCLC and 20 patients with SCLC. Blood samples will be collected from eligible patients only once at baseline. These samples will be immediately processed for CTCs and CTC derived xenografts.
  Cohort B: 15 patients with NSCLC and 15 patients with SCLC. Blood samples will be collected from eligible patients at baseline just prior to initiation of therapy. Samples will also be collected on day 1 of every cycle of therapy for 4 cycles (typical cycles are 21 days for chemotherapy, 28 days for targeted therapy and 14 days for immune therapy). At the time of initiation of the treatment break, blood samples will be collected. During the treatment break, patients will be followed every 6-12 weeks with imaging studies, and we will collect blood samples at each visit. At the time of disease progression in the event patient goes on best supportive care, the last blood draw will be at the time of this decision as there will unlikely be any further imaging studies going forward. If a patient is found to have disease progression while on active therapy, the next blood draw will be on the first day of the next therapy and time point of subsequent blood draws will depend on the type of therapy the patient receives. The goal is to define whether CTC loads whether CTC loads predict symptoms, response, and disease recurrence.
  For Cohorts A & B: Investigators will make every attempt to time the blood collection to coincide with blood collection for therapeutic purposes in order to minimize discomfort. Blood sample collection will take place in the outpatient clinic. Patients can participate in both cohorts simultaneously, or only one cohort per patient preference.
  Cohort C: 10 subjects. Blood samples will be collected from eligible health volunteers only once. These samples will be used to test the CTC chip system as investigators routinely spike (inject) tumor cell lines in healthy human blood to ensure optimal CTC yield (quality control). Two samples of peripheral blood will be collected and taken to the Principal Investigator's lab for processing.

Eligibility: Inclusion Criteria Cohort A (one-time blood sample) & Cohort B (multiple blood samples)
  -  Histologically or cytologically confirmed lung cancer (both non-small cell lung cancer and small cell lung cancer are allowed)
  -  Stage 4 NSCLC or extensive-stage SCLC
  -  Newly diagnosed disease with no prior systemic therapy for advanced disease Note: Patients that have received prior adjuvant chemotherapy or prior chemoradiotherapy for earlier stage lung cancer are allowed if treatment was completed ≥3 months.
  -  Age ≥ 18 years
  -  Ability to understand and the willingness to sign a written informed consent document
  Cohort C (healthy volunteers)
  -  Age > 18 years but ≤ 95 years at the time of consent
  -  Subjects must be English-speaking
  -  Must voluntarily sign the most current informed consent and HIPAA documents prior to study participation.
  -  Have no prior history of malignancy in the past 2 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers can also be enrolled as healthy volunteers.
  Inclusion of Women and Minorities Both men and women of all races and ethnic groups are eligible for this study.

Relevance to patient case: not relevant