NCT04306094

Brief Summary

This study is a cohort study with patients with advanced NSCLC. Patients will answer questionnaires about symptoms and quality of life and will be submitted to physical and blood tests, and computer tomography. The aim of this study is to estimate prognostic factors predicting survival to 3 months in patients with advanced NSCLC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

4.2 years

First QC Date

March 10, 2020

Last Update Submit

March 10, 2020

Conditions

NSCLC Stage IV

Keywords

prognostic factorsurvivallung cancer

Outcome Measures

Primary Outcomes (1)

  • overall survival

    to assess overall survival in patients with NSCLC

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NSCLC patient, treatment naive with Eastern Cooperative Oncology Group Performance status 2-4 (ECOG PS).

You may qualify if:

  • Advanced stage IVa or IVb NSCLC patients histologically diagnosis.
  • Eastern Cooperative Oncology Group Performance status 2 - 4
  • Treatment-naive

You may not qualify if:

  • Initiate treatment before initiate
  • psychiatric illnesses, except depression
  • pregnant or breastfeeding women
  • two concomitant neoplasms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana Paula de Souza Borges

São Paulo, 04513100, Brazil

RECRUITING

Related Publications (1)

  • Cunha MT, de Souza Borges AP, Carvalho Jardim V, Fujita A, de Castro G Jr. Predicting survival in metastatic non-small cell lung cancer patients with poor ECOG-PS: A single-arm prospective study. Cancer Med. 2023 Feb;12(4):5099-5109. doi: 10.1002/cam4.5254. Epub 2022 Sep 26.

    PMID: 36161783DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

ana p borges

CONTACT

+5511969057406aninhapsb@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician, MD

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 12, 2020

Study Start

November 1, 2017

Primary Completion

December 31, 2021

Study Completion

February 1, 2022

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

BR(1)