Biomarker Discovery and Validation in Lung Cancer

NCT01147562 | Unknown

• 1 other identifier: IBBL0001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Lung cancer is responsible for the most deaths due to cancer each year in both men and women worldwide and once diagnosed, the 10 year survival rate is poor (\<15%). This poor prognosis is based in large part on the absence of an effective diagnostic test for the disease. The chief objective of this study is to develop a molecular-based diagnostic test specific for lung cancer. Subjects suspected or diagnosed with lung cancers, who are either undergoing thoracentesis, biopsy of a suspicious lesion or surgical resection of their tumor will be asked to participate in this study. Those subjects, who will undergo surgical resection, will donate both lung tumor tissue and adjacent normal lung tissue (potentially including lymph nodes), while non-surgical candidates will donate a portion of their excess biopsy sample, if available, after diagnosis has been confirmed. Subjects undergoing thoracentesis for pleural effusion will donate a portion of their fluid sample, if the fluid volume collected is in excess of that needed for clinical care purposes. Blood samples and optionally saliva will also be collected from all subjects, whether undergoing surgery or not. In addition to biosample collection, detailed annotated demographic and clinical information will be collected from subjects. Subjects will be followed for outcome analysis, specifically for tumor recurrence, every 6 months, during 5 years. In case of change in chemotherapy treatment, biosamples and clinical information will also be collected. Collected biosamples will be analyzed using a series of molecular and proteomic technologies for developing biomarkers of the disease.

Conditions

Lung Cancer

Keywords

Lung cancer; Biopsy; Biomarker; Tissue Collection

Outcome Measures

Primary Outcomes (1)

• Discover and validate molecular biomarkers for lung cancer

  Investigate markers capable of prediciting response to chemotherapy. In cas a pulmonary nodule is diagnosed and has to be characterized, a biomarker could predict whether the nodule is or is not cancerous and thus, make CT Scan follow up unnecessary.

  Participants are followed up very 6 months up to to 5 years or until death.

Study Arms (1)

Lung Cancer Patients

OTHER

Patients with a suspected or confirmed diagnosis of lung cancer, whether or not scheduled for lesion biopsy, thoracentesis or surgical resection of their tumor

Procedure: Collection of biospecimen

Interventions

Collection of biospecimen PROCEDURE

Collection of saliva, blood and tissues from subjects diagnosed with lung cancer, who are scheduled for biopsy of their lesion or surgical resection of their tumor.

Lung Cancer Patients

Eligibility Criteria

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

You may qualify if:

• Patients with a suspected or confirmed diagnosis of lung cancer, whether or not scheduled for lesion biopsy, thoracentesis or surgical resection of their tumor

You may not qualify if:

• Pregnant women
• Minors (subjects less than 18 years of age)
• Prisoners
• Subjects unable to consent for themselves

Sponsors & Collaborators

• Dr. Guy Berchem: lead
• Integrated Biobank of Luxembourg: collaborator
• Centre Hospitalier du Luxembourg: collaborator

Study Sites (2)

Centre Hospitalier de Luxembourg (CHL)

Luxembourg, 1210, Luxembourg

Location

Clinique Sainte Thérèse (Zithaklinik)

Luxembourg, L-2763, Luxembourg

Location

Related Publications (2)

• Dziadziuszko R, Hirsch FR. Advances in genomic and proteomic studies of non-small-cell lung cancer: clinical and translational research perspective. Clin Lung Cancer. 2008 Mar;9(2):78-84. doi: 10.3816/CLC.2008.n.012.

  PMID: 18501093 BACKGROUND

• Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.

  PMID: 11784875 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Guy Berchem, MD

  Centre Hospitalier du Luxembourg

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: October 14, 2009
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

LU (2)