Clinical trial · Interventional
Biomarker Discovery and Validation in Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of biospecimen | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Lung Cancer Patients
- description
- Patients with a suspected or confirmed diagnosis of lung cancer, whether or not scheduled for lesion biopsy, thoracentesis or surgical resection of their tumor
- interventionNames
- Procedure: Collection of biospecimen
Primary outcomes (1)
- measure
- Discover and validate molecular biomarkers for lung cancer
- timeFrame
- Participants are followed up very 6 months up to to 5 years or until death.
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDDziadziuszko 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
- BACKGROUNDSchiller 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