Beating Lung Cancer in Ohio (BLCIO) Protocol

Who is this study for? Patients with stage IV non-small cell lung cancer
What treatments are being studied? FoundationOne assay and blood sample for analysis using FoundationACT blood circulating tumor DNA assay
Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This randomized clinical trial studies the Beating Lung Cancer in Ohio protocol in improving survival in patients with stage IV non-small cell lung cancer. The Beating Lung Cancer in Ohio protocol may help in evaluating immunotherapies and targeted therapies that prolong survival, have more favorable toxicity profiles than conventional chemotherapy and impact quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• AIM 1-3

• Pathologically confirmed stage IV NSCLC (with any Eastern Cooperative Oncology Group \[ECOG\] performance status, and any NSCLC - adenocarcinoma, squamous cell, etc.) with available imaging OR patients who do not yet have their staging completed, but in the judgment of the physician are likely to be stage IV;

⁃ Patients may be enrolled if the recruiter cannot reach the patient by the first office visit, preferably prior to starting therapy and no later than one month after starting therapy; (NCCN guidelines allow for a switch to targeted therapy from chemotherapy if testing comes back positive after starting chemotherapy)

• English speaking; and

• Willing to provide access to medical records, insurance and billing data, biospecimens and respond to questionnaires, typically by phone, but possibly to include online or in-person surveys

• AIM 3 ONLY

• Patients must be current smokers who smoke at least one cigarette most days per week, or recent quitters who smoked at least one cigarette most days per week (\< 3 months); and

• Household members must be current smokers, defined as smoking at least one cigarette most days per week

• Hearing and vision impairments that would prevent ability to complete consent, interviews, or sample collection

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Contact Information
Primary
The Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Backup
Sarah Reisinger
Sarah.Reisinger@osumc.edu
614-366-4542
Time Frame
Start Date: 2017-07-17
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 3584
Treatments
Active_comparator: Arm I (UC)
Patients receive usual care and undergo collection of tumor tissue and blood sample for the repository. Patients who smoke or have recently quit smoking and their household members who smoke may also undergo smoking cessation via usual care or NCCN driven-CTC/DS.
Experimental: Arm II (AGIT/DS)
Patients undergo collection of tumor tissue for analysis using FoundationOne assay and blood sample for analysis using FoundationACT blood circulating tumor DNA assay. Patients who smoke or have recently quit smoking and their household members who smoke may also undergo smoking cessation via usual care or NCCN driven-CTC/DS.
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov