Cachexia in NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional and Skeletal Muscle Implications

NCT03960034 | Completed

• 1 other identifier: NP802/15
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

LUCAX01 is a cohort study with patients with advanced NSCLC in tobacco users. in this study, patients will be submitted to baseline physical tests, blood and biopsy sample collection, and the main objective is to study the functional and prognostic implications of cachexia and to validate skeletal muscle dysfunction markers.

Conditions

NSCLC Stage IV

Keywords

Cachexia; Skeletal Muscle Atrophy; Physical Functional Performance; Prognosis

Outcome Measures

Primary Outcomes (1)

• Overall survival in cachectic and non-cachectic patient

  Survival will be measured to understand the prognostic impact of cancer cachexia in NSCLC patients.

  2 year

Secondary Outcomes (6)

• Physical fitness and response to treatment

  1 year

• Physical fitness and toxicity

  1 year

• Cancer cachexia skeletal muscle pathways

  1 year

• Cluster of Differentiation 4+ (CD4+) population in cachectic and non-cachectic patient.

  1 year

• Cluster of Differentiation 25+ (CD25+) population.

  1 year

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NSCLC patient, current smokers or ex-smokers treatment naive with good Eastern Cooperative Oncology Group Performance status (ECOG-PS). A smoker population with no known cancer will be used as controls (n=10)

You may qualify if:

• Advanced stage IVa or IVb NSCLC patients histologically diagnosis.
• Eastern Cooperative Oncology Group Performance status 0 - 2
• Treatment-naive
• Current smokers or ex-smokers
• Normal renal, hepatic and hematological functions
• Able to perform the physical functional tests
• Able to read and sign the consent form

You may not qualify if:

• Initiate treatment before initiate
• Diagnostic of tumor mutation ( epidermal growth factor receptor, Anaplastic lymphoma kinase)
• Obs: A smoker population with no known cancer will be used as controls (n=10)

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skeletal muscle from vastus lateralis and whole blood, blood plasma and peripheral blood mononuclear cells.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Cachexia; Muscular Atrophy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Gilberto de Castro Junior, MD, PhD

  Instituto do Câncer do Estado de São Paulo - FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 22, 2019
• Study Start: April 10, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

BR (1)