Lung Cancer Mutation Consortium Protocol

Study ID
STU 012011-008

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Laurin Priddy
214-648-1688
laurin.loudat@utsouthwestern.edu

Principal Investigator
Joan Schiller

Summary

Patients with stage iV adenocarcinoma of the lung who have undergone biopsy with remnant tissue available will be selected for this study to have their tumors tested for mutations and compared to clinical data collected by way of questionnaires which can either be completed from the subject's medical record or by meeting with the subject to complete the questionnaire. Subjects who agree will continue to be followed yearly for survival, treatment information and disease status either via a phone call or by reviewing the medical records of subjects who remain in treatment at this cancer center.

3000 subjects will be enrolled for the entire study. To account for screen failed subjects with insufficient/inadequate tumor tissue, up to 3000 subjects may be enrolled nationwide to ensure analysis of 3000 cases. uT Southwestern plans to contribute 110 of these subjects over a two-year period. Patients who were originally diagnosed with early stage disease who have since recurred will be eligible for participation. Tissue on these subjects may come from either their original resection or a biopsy documenting their most recent recurrence. This study does not involve treatment arms or randomization or use of any interventional or therapeutic medication or device.

Participant Eligibility

1. Subjects (> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of stage IV adenocarcinoma of the lung.
2. Oral and written informed consent.
3. Participants must have a Southwest Oncology Group (SWOG) performance status of 0-2. [Performance status is an assessment of a subject[Single Quote]s ability to perform the activities of daily living. If a performance status assessment is not already available from the patient[Single Quote]s medical record, an assessment of this status can be made by the physician or nurse practitioner at the time of informed consent.]
4. Stage IV adenocarcinoma diagnosis date of May 1, 2012 or later
5. Spanish-speaking subjects will be eligible for participation.