Clinical trial · Observational
Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to provide high quality oncology services to patients with inoperable Non-Small Cell Lung Cancer (NSCLC) in Greece. These services will be based on 3 pillars: 1. Clinical: personalized treatment will be administered and its effectiveness and safety will be recorded and evaluated. 2. Molecular: the gene footprint of each patient at the beginning of his treatment, the molecular identity of his tumor will be analyzed and recorded based on analysis with modern Next Generation Sequencing (NGS) techniques. 3. Digital: Patients will have access to the digital platform where they will record the adverse reactions they will face during their treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Carcinoma of Lung, TNM Stage 4 | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital platform | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients who will receive digital assistant
- description
- Patients will receive digital assistance (in a few words text format) for any symptoms/adverse events they will include in their profile in the digital platform.
- interventionNames
- Other: Digital platform
- label
- Patients who will not receive digital assistant
- description
- Patients will just include any symptoms/adverse events in their profile in the digital platform.
Primary outcomes (1)
- measure
- Molecular identification of patients with non-small cell lung cancer
- timeFrame
- up to 36 months
Secondary outcomes (2)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with non-small cell lung cancer stage IV * No younger than 18 years old patients * Performance status: 0-2 * Existence of biological material for the molecular analysis * Patients who have not been treated with any other treatment than adjuvant * Ability to use a mobile device or computer for digital communication Exclusion Criteria: * Childbearing women * Patients with PS \> 3 * Limited ability to use a mobile device for basic digital communication
References
Publications (17)
- BACKGROUNDFountzilas G, Giannoulatou E, Alexopoulou Z, Zagouri F, Timotheadou E, Papadopoulou K, Lakis S, Bobos M, Poulios C, Sotiropoulou M, Lyberopoulou A, Gogas H, Pentheroudakis G, Pectasides D, Koutras A, Christodoulou C, Papandreou C, Samantas E, Papakostas P, Kosmidis P, Bafaloukos D, Karanikiotis C, Dimopoulos MA, Kotoula V. TP53 mutations and protein immunopositivity may predict for poor outcome but also for trastuzumab benefit in patients with early breast cancer treated in the adjuvant setting. Oncotarget. 2016 May 31;7(22):32731-53. doi: 10.18632/oncotarget.9022. PMID 27129168
- BACKGROUNDRothberg JM, Hinz W, Rearick TM, Schultz J, Mileski W, Davey M, Leamon JH, Johnson K, Milgrew MJ, Edwards M, Hoon J, Simons JF, Marran D, Myers JW, Davidson JF, Branting A, Nobile JR, Puc BP, Light D, Clark TA, Huber M, Branciforte JT, Stoner IB, Cawley SE, Lyons M, Fu Y, Homer N, Sedova M, Miao X, Reed B, Sabina J, Feierstein E, Schorn M, Alanjary M, Dimalanta E, Dressman D, Kasinskas R, Sokolsky T, Fidanza JA, Namsaraev E, McKernan KJ, Williams A, Roth GT, Bustillo J. An integrated semiconductor device enabling non-optical genome sequencing. Nature. 2011 Jul 20;475(7356):348-52. doi: 10.1038/nature10242. PMID 21776081
- BACKGROUNDHovelson DH, McDaniel AS, Cani AK, Johnson B, Rhodes K, Williams PD, Bandla S, Bien G, Choppa P, Hyland F, Gottimukkala R, Liu G, Manivannan M, Schageman J, Ballesteros-Villagrana E, Grasso CS, Quist MJ, Yadati V, Amin A, Siddiqui J, Betz BL, Knudsen KE, Cooney KA, Feng FY, Roh MH, Nelson PS, Liu CJ, Beer DG, Wyngaard P, Chinnaiyan AM, Sadis S, Rhodes DR, Tomlins SA. Development and validation of a scalable next-generation sequencing system for assessing relevant somatic variants in solid tumors. Neoplasia. 2015 Apr;17(4):385-99. doi: 10.1016/j.neo.2015.03.004. PMID 25925381
- BACKGROUNDLuthra R, Patel KP, Routbort MJ, Broaddus RR, Yau J, Simien C, Chen W, Hatfield DZ, Medeiros LJ, Singh RR. A Targeted High-Throughput Next-Generation Sequencing Panel for Clinical Screening of Mutations, Gene Amplifications, and Fusions in Solid Tumors. J Mol Diagn. 2017 Mar;19(2):255-264. doi: 10.1016/j.jmoldx.2016.09.011. Epub 2016 Dec 23. PMID 28017569