Clinical Trial: Telomere Biology in Early Adenocarcinoma of the Lung

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prospective Cohort Study of Telomere Biology Among Patients With Early Adenocarcinoma of the Lung

Brief Summary:

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.


Detailed Summary:

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 r
Sponsor: Meir Medical Center

Current Primary Outcome: Telomere Capture Percentage [ Time Frame: one-time peripheral blood sample ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Meir Medical Center

Dates:
Date Received: September 10, 2014
Date Started: September 2014
Date Completion: September 2017
Last Updated: September 10, 2014
Last Verified: September 2014