Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Telomere Biology in Early Adenocarcinoma of the Lung

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 10, 2014
First Posted Date September 12, 2014
Last Update Posted Date September 12, 2014
Study Start Date September 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2014)
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 Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Telomere Biology in Early Adenocarcinoma of the Lung
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 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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)
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.
Condition
  • Adenocarcinoma of the Lung
  • Adenocarcinoma, Bronchiolo-Alveolar
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 10, 2014)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2017
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02239432
Other Study ID Numbers 0067-14-MMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Meir Medical Center
Verification Date September 2014