An observational study in Adenocarcinoma of the Lung and Adenocarcinoma, Bronchiolo-Alveolar, sponsored by Meir Medical Center. Status unknown at 2 sites in Israel. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-12.
Sponsored by Meir Medical Center · Observational
Early adenocarcinoma of the lung has an excellent five-year survival after resection. However, its clinical and radiologic presentation is highly variable. Traditional means for preoperative diagnosis such as Positron Emission Tomography (PET-CT) and trans-thoracic needle biopsy demonstrate unacceptable false positive and negative rates.
Telomere biology is activated aberrantly is most lung cancers but has not been studied in early stages to the best of our knowledge.
The objective of this study is to evaluate telomere length and activity with suspected early stage adenocarcinoma of the lung.
Bronchoalveolar carcinoma has been traditionally used to refer to a subset of adenocarcinoma distinguished by its peripheral location, typical "lepidic" growth pattern and tendency for both bronchogenic and lymphatic spread. For the purpose of this discussion and consistency with the revised 2011 criteria, BAC subtypes will be collectively referred to as early adenocarcinoma.
The clinical presentation of early adenocarcinoma subtypes is highly variable ranging from a small solitary nodule to extensive lobar consolidation. Many peripheral lesions have a characteristic ground glass opacity appearance on Chest CT, which may correlate with an improved prognosis. The reported five-year disease-free survival after resection for isolated lesions may approaches 100%.
Preoperative diagnosis of such lesions is complicated by several limitations. First, the differential diagnosis is broad including an extensive number of inflammatory and infectious processes. Second, positron emission tomography (PET), which identifies regions of increased metabolic activity, may be falsely negative due to the slow growth of early adenocarcinoma lesions. Transbronchial needle biopsy is also unreliable to confirm or exclude disease in non-solid type lesions.
The proportion of lung cancers classified as adenocarcinoma has steadily increased and now comprises nearly ½ of cases. However, the proportion of adenocarcinoma in situ is uncertain. Previous reports range from 5-10% in a large series to as high as 24% in the large Surveillance, Epidemiology and End Results database. Thus, these early adenocarcinoma lesions may represent a disproportionately large number of lung cancers which are PET negative yet carry an excellent prognosis after early resection. The early adenocarcinoma subtypes represent a clinical entity requiring further characterization to distinguish lesions more likely to be malignant from benign.
Telomerase is activated aberrantly in most lung cancers and mutations in telomerase components predispose to solid malignancies. For patients with non-small cell lung cancer, numerous studies correlate increased tumor telomerase activity with increased likelihood of Stage IIIB and Stage IV disease and/or reduced survival. Furthermore, telomerase inhibition is currently being studied in clinical trials of patients with advanced non-small lung cancer.
Problem:
The semi-solid lung lesion may represent early stage adenocarcinoma which has an excellent prognosis upon early diagnosis and prompt surgical resection. However, the semi-solid lesion has a broad differential diagnosis and preoperative features characteristic of adenocarcinoma are needed to distinguish malignant from benign lesions.
Objective:
To study telomere length and telomerase activity in patients with suspected early adenocarcinoma of the lung whom are referred for surgical biopsy of lung lesions.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 100 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.
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Patients referred by a multi-disciplinary team meeting recommendation for surgical lung biopsy due to suspected adenocarcinoma of the lung.
Patients referred by a multi-disciplinary team meeting recommendation for surgical lung biopsy due to suspected adenocarcinoma of the lung and agree to a one-time peripheral blood sample for telomere analysis as described.
Exclusion Criteria:
Patients whom were not evaluated by the multi-disciplinary team discussion prior to referral for surgical lung biopsy.
Patients with other chronic inflammatory disease requiring immunosuppressive therapy or known extra-pulmonary malignancy.
Patients with suspected adenocarcinoma of the lung referred for surgical lung biopsy after multi-disciplinary team recommendation.
Age and sex-matched patients with no known lung disease or other chronic inflammatory disease or malignancy
Patients with biopsy-proven advanced solid malignancy of the lung
Telomere Capture Percentage
According to our previous experience with telomore biology in different disease states, we estimate a standard deviation (SD) of 1.3 of telomere capture (%) for the controls (healthy patients without known lung disease) and a SD of 2.4 (TC%) for biopsy-proven adenocarcinoma of the lung. For a clinically significance of at least 2%, we estimate a sample size of at least 16 patients with biopsy-proven disease to detect a statistically significant of 5% with a power of 80% (calculated by the independent t-test).
Time frame: one-time peripheral blood sample
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Meir Medical Center