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Telomere Biology in Early Adenocarcinoma of the Lung

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ClinicalTrials.gov Identifier: NCT02239432
Recruitment Status : Unknown
Verified September 2014 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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.


Condition or disease
Adenocarcinoma of the Lung Adenocarcinoma, Bronchiolo-Alveolar

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study of Telomere Biology Among Patients With Early Adenocarcinoma of the Lung
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Suspected Adenocarcinoma of the Lung
Patients with suspected adenocarcinoma of the lung referred for surgical lung biopsy after multi-disciplinary team recommendation.
Healthy Control
Age and sex-matched patients with no known lung disease or other chronic inflammatory disease or malignancy
Age-matched controls with proven solid lung malignancy
Patients with biopsy-proven advanced solid malignancy of the lung



Primary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples Without DNA
One peripheral blood sample is taken for lymphocyte culture and subsequently telomere length and activity analysis (previously described, Laish I, Gene 2013;529:245-9)


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients referred by a multi-disciplinary team meeting recommendation for surgical lung biopsy due to suspected adenocarcinoma of the lung.
Criteria

Inclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239432


Contacts
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Contact: Matthew Koslow, M.D. +972-3-52-603-5410 mkoslow73@gmail.com
Contact: David Shitrit, M.D. +972-9-747-1556 Davids3@clalit.org.il

Locations
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Israel
Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Contact: Yael Rafaely, M.D.       YaelRefaely@clalit.org.il   
Contact: Alina Zilberman, Msc       ElinuRu@clalit.org.il   
Principal Investigator: Yael Rafaely, M.D.         
Meir Medical Center Recruiting
Kfar Saba, Israel, 4428164
Contact: Matthew Koslow, M.D.    +972-52-603-5410    mkoslow73@gmail.com   
Principal Investigator: Matthew Koslow, M.D.         
Sponsors and Collaborators
Meir Medical Center

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02239432     History of Changes
Other Study ID Numbers: 0067-14-MMC
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014
Keywords provided by Meir Medical Center:
Adenocarcinoma of the Lung
Adenocarcinoma, Bronchiolo-Alveolar
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Adenocarcinoma, Bronchiolo-Alveolar
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site