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

NCT04634630 | Completed

• 1 other identifier: STEMCELL/1
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung Cancer, Nonsmall Cell; Relapse/Recurrence; CSC

Keywords

Non Small Cell Lung Cancer; Cancer Stem Cells

Outcome Measures

Primary Outcomes (1)

• Relapse Free Survival

  Days from lung cancer resection to relapse

  Minimum follow-up time: 1 year

Interventions

Exposure to lung cancer stem cells GENETIC

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent major lung resection by lateral thoracotomy or videothoracoscopic approach for stage I, II, or IIIA adenocarcinoma or squamous cell carcinoma of the lung (tumor, node, metastasis (TNM) staging system, eighth edition)

You may qualify if:

• 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

You may not qualify if:

• incomplete resection
• unknown tumor, node or metastasis status
• synchronous tumors
• previous lung cancer

Sponsors & Collaborators

• Beatrice Aramini: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Modena

Modena, 41124, Italy

Location

Related Publications (2)

• Masciale V, Banchelli F, Grisendi G, D'Amico R, Maiorana A, Stefani A, Morandi U, Stella F, Dominici M, Aramini B. Cancer Stem Cells and Cell Cycle Genes as Independent Predictors of Relapse in Non-small Cell Lung Cancer: Secondary Analysis of a Prospective Study. Stem Cells Transl Med. 2022 Aug 23;11(8):797-804. doi: 10.1093/stcltm/szac040.

  PMID: 35674389 DERIVED

• Masciale V, Banchelli F, Grisendi G, D'Amico R, Maiorana A, Stefani A, Morandi U, Stella F, Dominici M, Aramini B. The Influence of Cancer Stem Cells on the Risk of Relapse in Adenocarcinoma and Squamous Cell Carcinoma of the Lung: A Prospective Cohort Study. Stem Cells Transl Med. 2022 Mar 31;11(3):239-247. doi: 10.1093/stcltm/szab029.

  PMID: 35356974 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Uliano Morandi, MD

  Azienda Ospedaliero-Universitaria di Modena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Thoracic Surgery

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: October 17, 2017
• Primary Completion: October 17, 2020
• Study Completion: October 17, 2020
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)