Telomere Biology in Early Adenocarcinoma of the Lung
Prospective Cohort Study of Telomere Biology Among Patients With Early Adenocarcinoma of the Lung
1 other identifier
observational
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2014
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedSeptember 12, 2014
September 1, 2014
2 years
September 10, 2014
September 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
one-time peripheral blood sample
Study Arms (3)
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
Eligibility Criteria
Patients referred by a multi-disciplinary team meeting recommendation for surgical lung biopsy due to suspected adenocarcinoma of the lung.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Soroka University Medical Center
Beersheba, 84101, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Biospecimen
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2014
First Posted
September 12, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2017
Last Updated
September 12, 2014
Record last verified: 2014-09