Adenocarcinoma of the LungNCT02239432
Telomere Biology in Early Adenocarcinoma of the Lung
An observational study of Adenocarcinoma of the Lung and Adenocarcinoma, Bronchiolo-Alveolar, run by Meir Medical Center at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenocarcinoma of the Lung, Adenocarcinoma, Bronchiolo-Alveolar
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2014to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred by a multi-disciplinary team meeting recommendation for surgical lung biopsy due to suspected adenocarcinoma of the lung.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Soroka University Medical Center
Beersheba, 84101
Yael Rafaely, M.D., YaelRefaely@clalit.org.il
Alina Zilberman, Msc, ElinuRu@clalit.org.il
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
Matthew Koslow, M.D., +972-52-603-5410, mkoslow73@gmail.com
Matthew Koslow, M.D.
About this study
Official title: Prospective Cohort Study of Telomere Biology Among Patients With Early Adenocarcinoma of the Lung
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.
Read the 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.
- Keywords
- Adenocarcinoma of the Lung, Adenocarcinoma, Bronchiolo-Alveolar
- Medical subject headings
- Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one-time peripheral blood sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239432
- Sponsor's protocol ID
- 0067-14-MMC
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Telomere Biology Among Patients With Early Adenocarcinoma of the Lung
- ClinicalTrials.gov ID
- NCT02239432
- Acronym / sponsor ID
- 0067-14-MMC
- Keywords
- Adenocarcinoma of the Lung, Adenocarcinoma, Bronchiolo-Alveolar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred by a multi-disciplinary team meeting recommendation for surgical lung biopsy due to suspected adenocarcinoma of the lung.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of the Lung and Adenocarcinoma, Bronchiolo-Alveolar, run by Meir Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Koslow, M.D. (+972-3-52-603-5410, mkoslow73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere Capture Percentage (time frame: one-time peripheral blood sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.