Treatment of Multifocal Lung Adenocarcinoma

NCT01946100 | Terminated

• 1 other identifier: 12-007569
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.

Conditions

Lung Neoplasms; Carcinoma Non-small-cell Lung; Adenocarcinoma

Keywords

multifocal; genetic; bronchoalveolar carcinoma; adenocarcinoma in situ; ground glass opacity; next generation sequencing

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival compared to survival for Stage IV NSCLC on NCCTG trials

  2 years

Secondary Outcomes (3)

• Progressive free survival

  Every 3 months for 2 years

• Treatment Morbidity and Mortality

  2 years

• Post-treatment Pulmonary Function

  2 years

Study Arms (1)

Multifocal Lung Adenocarcinoma

OTHER

Genetic: Multifocal Lung Adenocarcinoma

Interventions

Multifocal Lung Adenocarcinoma GENETIC

Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.

Multifocal Lung Adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Patient must be \> 18 years of age * Two or more GGO's or solid lesions suspicious for multifocal disease. * Clinical diagnosis of N0 * No evidence of distant metastases * No prior intra-thoracic radiation therapy (NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted.), previous chemotherapy, or surgical resection for non-small cell lung cancer (NSCLC). * No other cancer in the past 5 years except early stage prostate cancer, or basal cell of skin. * PFT's that show patient is capable of tolerating a lung resection. * Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study. * Patient must be able to understand and willing to sign an IRB-approved informed consent document.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Saddoughi SA, Powell C, Stroh GR, Rajagopalan S, Bartholmai BJ, Boland JM, Aubry MC, Harmsen WS, Blackmon SH, Cassivi SD, Nichols FC, Reisenauer JS, Shen KR, Mansfield AS, Maldonado F, Peikert T, Wigle DA. Long-Term Survival and CANARY-Based Artificial Intelligence for Multifocal Lung Adenocarcinoma. Mayo Clin Proc Digit Health. 2024 Jan 11;2(1):44-52. doi: 10.1016/j.mcpdig.2023.10.006. eCollection 2024 Mar.

  PMID: 40206677 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Adenocarcinoma, Bronchiolo-Alveolar; Adenocarcinoma in Situ

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma of Lung; Carcinoma in Situ; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis Wigle, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 19, 2013
• Study Start: November 6, 2013
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (1)