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NCT04634630 Clinical Trial

The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung

Lung Cancer, Nonsmall Cell Clinical Trial

Official title:
The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04634630
Other study ID # STEMCELL/1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 17, 2017
Est. completion date October 17, 2020

Study information
Verified date May 2021
Source Azienda Ospedaliero-Universitaria di Modena
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The present study is a prospective cohort study. The aim is to assess the relationship between the presence of cancer stem-cells (CSC) and the risk of relapse in patients with early and locally advanced adenocarcinoma and squamous cell carcinoma of the lung

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date October 17, 2020
Est. primary completion date October 17, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - patients with stage I, II or IIIA adenocarcinoma of squamous cell carcinoma of the lung - age between 18 and 85 - R0 resection - availability of formalin-fixed, paraffin-embedded surgery specimen from the primary tumor - availability of fresh surgical specimen for cytofluorimetric analysis Exclusion Criteria: - incomplete resection - unknown tumor, node or metastasis status - synchronous tumors - previous lung cancer

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• Exposure to lung cancer stem cells
The exposure to lung cancer stem cells was measure as the percentage of Aldehyde dehydrogenase (ALDH) on all viable cells extracted from surgically resected tumor specimens

Locations
Country Name City State
Italy Azienda Ospedaliero-Universitaria di Modena Modena

Sponsors (1)
Lead Sponsor Collaborator
Beatrice Aramini

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relapse Free Survival Days from lung cancer resection to relapse Minimum follow-up time: 1 year
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