Immune- and Microenvironment- Proteogenomics Profiling for Classifying Lung Cancer Patients

NCT04887545 | Unknown

• 2 other identifiers: UniversidadeNL_3008802/SAICT/2017_30088
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The excessive accumulation of fluid between the membranes surrounding the lung, a clinical condition commonly referred to as "pleural effusion", is caused by one of three factors: increased production of pleural fluid, decreased ability to reabsorb pleural fluid or a mixture both. The basis of pleural effusion accumulation may originate from multiple pathologies: from benign and extrapulmonary conditions to intrinsic pleural pathology (inflammatory or neoplastic primary or metastatic) in which the accumulation of fluid in the pleural space is mainly due to changes in the structure of the pleural membrane (loss of integrity and / or infiltration by neoplastic cells). An example of extrapulmonary conditions is the pleural effusion observed in patients with congestive heart failure in which there is increase in hydrostatic capillary pressure, due to failure of the cardio circulatory pump. The distinction between benign and malignant causes is currently a diagnostic challenge that usually requires the collection of material (cells immersed in the pleural fluid or even a histological sample). The first step of this investigation is currently the cytological evaluation of the pleural fluid, that is, the observation of cells, of an initial sample of the pleural fluid. This procedure is associated with an average sensitivity of 62% while a second sample through thoracentesis improves the sensitivity of the diagnosis by 10%. In certain cases, however, it is not possible to diagnose by analyzing the pleural fluid and, as a rule, a more invasive diagnostic method is recommended, such as pleural biopsy (collected by puncture with a "blind" needle, echo guided or computed tomography guided or obtained by means of direct visualization of the pleural cavity through pleuroscopy). The diagnostic yield of this approach can reach up to 97% (in the case of pleural biopsy obtained by medical thoracoscopy). However, it implies greater morbidity and greater consumption of resources (material and human). The development of a more sensitive and specific and at the same time less invasive diagnostic method for pleural fluid may contribute to a more effective screening of patients, limiting the use of more invasive methods to only patients with a higher risk of malignant pathology.

Conditions

Lung Cancer; Malignancy

Keywords

pleural effusion; thoracentesis; transudate; exudates

Outcome Measures

Primary Outcomes (1)

• diagnosis of lung cancer by histological examination of surgically-excised nodules

  diagnosis of lung cancer by histological examination of surgically-excised nodules

  6 months

Study Arms (1)

Thoracentesis

Patients who need removal of excess pleural effusion and assessed for the possibility of lung cancer.

Diagnostic Test: Proteomics analysis of pleural effusion

Interventions

Proteomics analysis of pleural effusion DIAGNOSTIC_TEST

Pleural effusion removed as part of standard care is fractionized and analyzed by mass spectrometry

Thoracentesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects evaluated by thoracentesis at Hospital CUF Descobertas and CUF Infante Santo and at the Local Health Unit of Guarda may participate.

You may qualify if:

• Candidate for diagnostic thoracentesis.
• The General Data Protection Regulation (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016) and the Law on Personal Genetic Information and Health Information (Decree-Law no. 131/2014) is fulfilled.
• Participation in the Study is completely voluntary.
• It is possible to drop out of the study at any time without affecting the quality of medical care.
• The information obtained from this study may originate scientific publications, without jeopardizing the anonymity of the Participants.
• During the course of the Study, it is possible to ask the investigators questions that you consider convenient.
• This study does not impose any cost on the participants.

You may not qualify if:

• Participants with unstable / severe medical illness (per investigator's judgment), coagulopathies and / or bleeding disorders, immunodeficiency syndromes (primary or acquired - including HIV infection), active and untreated HCV infection, HBV and active history of intravenous drug addictions.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Hospital Cuf Descobertas: collaborator

Study Sites (1)

Hospital CUF Descorbertas

Lisbon, Parque Das Nacoes, 1998-018, Portugal

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Pleural effusion contains cells. We aim to both characterize the proteome of protein fractions of the acellular pleural effusion and the cellular component. DNA is not the target of the study.

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms; Pleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases

Study Officials

• Rune Matthiesen, PhD

  Computational and Experimental Biology Group NOVA MEDICAL SCHOOL / FACULDADE DE CIÊNCIAS MÉDICASUNIVERSIDADE NOVA DE LISBOARua Câmara Pestana, 6-6A | 1150-082 Lisboa Portugal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rune Matthiesen, PhD

CONTACT

939218696; rune.matthiesen@nms.unl.pt

Ana S Carvalho, PhD

CONTACT

962615903; ana.carvalho@nms.unl.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: October 1, 2018
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

PT (1)