Telomere Biology in Early Adenocarcinoma of the Lung

Learn more about:
Related Clinical Trial
A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer Phase 1/2 Study of CISH Inactivated TILs in the Treatment of NSCLC Prognostic Value of Lung Cancer MicroAnatomy in 3D APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma Evaluation of Correlations Between Radiologic Features and Pathologic Subtypes of GGO LUAD Via WMS Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy ctDNA-MRD Based Adjuvant Targeted Therapy for EGFR Positive Stage I Lung Adenocarcinomas Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis Therapeutic ResistAnce and Clonal Evolution of ICIs Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Icotinib for Completed Resected IB NSCLC With EGFR Mutation Circulating Tumor DNA in Patients at High Risk for Lung Cancer Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery QUILT-3.017: Study of NEO-201 in Solid Tumors Photodynamic Therapy in Treating Patients With Lung Cancer Vaccine Treatment for Advanced Non-Small Cell Lung Cancer S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC The Tracking Molecular Evolution for NSCLC (T-MENC) Study Phase 1a/1b Study of TPST-1495 Alone and With Pembrolizumab in Subjects With Solid Tumors An Integrated Approach to Treating Recurrent Thoracic Carcinomas Resistant to Tyrosine Kinase Inhibitors Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC) P2 of RMT in Combo w Durvalumab or Durva + Chemo in Untreated Adenocarcinoma NSCLC Feasibility and Safety of Nintedanib in Combination With Nivolumab in Pretreated Patients With Advanced or Metastatic NSCLC of Adenocarcinoma Histology Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer Combination Nab-paclitaxel (N-P) and Nintedanib or N-P and Placebo in Relapsed NSCLC Adenocarcinoma Prospective Radiological Study of HRCT to Predict Pathological Noninvasiveness in NSCLC To Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer Impact of Concomitant Genetic Alterations in EGFR Mutated Adenocarcinoma by NGS Analysis: A Multicenter Study Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001) Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung Lung Cancer Mutation Consortium Protocol The Detection of EGFR Mutations in Liquid Based Cytology Samples NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma A Safety and Efficacy Study of Farletuzumab in Subjects With Adenocarcinoma of the Lung Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03) Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR Telomere Biology in Early Adenocarcinoma of the Lung

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


Primary Outcome

Telomere Capture Percentage


Condition

Adenocarcinoma of the Lung


Study Arms / Comparison Groups

 Suspected Adenocarcinoma of the Lung
Description:  Patients with suspected adenocarcinoma of the lung referred for surgical lung biopsy after multi-disciplinary team recommendation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

September 2014

Completion Date

September 2017

Primary Completion Date

September 2016

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.
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, +972-3-52-603-5410, [email protected]

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT02239432

Organization ID

0067-14-MMC


Responsible Party

Sponsor

Study Sponsor

Meir Medical Center


Study Sponsor

, , 


Verification Date

September 2014