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Biomarker Discovery and Validation in Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Biomarker Discovery and Validation in Lung Cancer


The primary objective of this study is to discover and validate molecular biomarkers for
lung cancer.

Lung cancer remains the leading cause of cancer death in industrialized countries. Most
patients with non-small cell lung cancer (NSCLC) present with advanced disease, and despite
recent advances in multi-modality therapy, the overall 10-year survival rate is less than
10%. A significant minority of patients (25−30%) with NSCLC have stage I disease and
receive surgical intervention alone. Although 35−50% of patients with stage I disease will
relapse within 5 years, it is not currently possible to identify specific high-risk
patients. In addition, for patients with metastatic disease, standard chemotherapeutic
approaches result in less than 50% response rate, meaning that more than half of patients do
not benefit and only suffer from side effects.

Only very limited data exists on markers capable of predicting response to chemotherapy.

This population would certainly also benefit from more of those markers. Another situation
where a biomarker could be potentially very useful is the situation where a pulmonary nodule
is diagnosed and has to be characterized. In this situation a biomarker could predict
whether the nodule is or is not cancerous and thus, make CT Scan follow up unnecessary.


Inclusion Criteria:



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

Exclusion Criteria:

- Pregnant women

- Minors (subjects less than 18 years of age)

- Prisoners

- Subjects unable to consent for themselves

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Discover and validate molecular biomarkers for lung cancer

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Authority:

Luxembourg: Comite National d'Ethique de Recherche

Study ID:

IBBL0001

NCT ID:

NCT01147562

Start Date:

October 2009

Completion Date:

October 2019

Related Keywords:

  • Lung Cancer
  • Lung cancer
  • Biopsy
  • Biomarker
  • Tissue Collection
  • Lung Neoplasms

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