Detection of Circulating Tumour Cells, Spread Through Air Space in Patients With Lung Cancer

NCT06833632 | Recruiting

• 1 other identifier: CTC22
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the prognostic impact of the presence of circulating tumour cells Circulating Tumour Cells (CTCs), Spread Through Air Space (STAS) and lymph node micrometastases in patients undergoing radical surgery for non-small cell lung neoplasia

Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Overall survival (OS)

  Overall survival (in months) will be assessed for each patient enrolled in the study from the day of surgery to the last follow-up or death whichever comes first

  Through study completion, up to 36 months.

• Disease-free survival (DFS)

  DFS (in months) will be assessed for each patient enrolled in the study: the relapse is defined as the first evidence of recurrence of disease on instrumental examinations instrumental examinations performed in the follow-up.

  Through study completion, up to 36 months.

• Global recurrence rate

  Percentage of patients with any recurrence

  Through study completion, up to 36 months.

• Type of recurrence

  Number of patients with local, regional distant or multiple recurrence

  Through study completion, up to 36 months.

Secondary Outcomes (5)

• Circulating Tumour Cells (CTC)

  Through study completion, the day before surgery and 30 days after surgery, up to 36 months.

• Spread through air space (STAS)

  Through study completion, at the time of pathological analysis of surgical specimen (approximately 36 months)

• Micrometastases at lymph nodes

  Through study completion, at the time of pathological analysis of surgical specimen (approximately 36 months)

• Molecular mutations in EGFR, ALK, ROS1, KRAS genes

  Through study completion, at the time of pathological analysis of surgical specimen (approximately 36 months)

• PD-L1 expression

  Through study completion, at the time of pathological analysis of surgical specimen (approximately 36 months)

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

The study is low-risk, human-tissue, prospective, single-center experimental study conducted on patients undergoing surgery for removal of stage I-IIA NSCLC.

You may qualify if:

• obtaining voluntary written informed consent
• diagnosis of NSCLC
• clinical stage I-IIA cN0
• Candidates for surgical resection

You may not qualify if:

• Pregnancy
• Induction therapy for pulmonary neoplasia
• Patients who have received systemic treatment for previous cancers in the last three years prior to lung surgery
• Any previous surgery for lung cancer
• Patients with other active neoplasms
• Infiltration of the chest wall

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS - Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples will be evaluated for major NSCLC driver mutations by multigenic panels with NGS (next generation sequencing) and immunohistochemical expression of PDL1 will be tested on both primary tumour and CTC (only on the preoperative sample).

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pietro Bertoglio, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Bertoglio, MD

CONTACT

051 647 8362; pietro.bertoglio@ausl.bologna.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 19, 2025
• Study Start: May 25, 2023
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-10

Locations

IT (1)