NCT06626243

Brief Summary

The study is a retrospective observational study. The study is designed to be multicentric and international and it will analyze medical records from selected patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy. There are no risks for the patients, as this is a retrospective data collection.

Trial Health

60
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
2 countries

6 active sites

Status
recruiting

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

September 30, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

October 1, 2024

Last Update Submit

November 26, 2024

Conditions

Non-Small Cell Lung Cancer

Keywords

Video-Assisted Thoracoscopic SurgeryRobot-Assisted Thoracoscopic Surgeryopen approach

Outcome Measures

Primary Outcomes (3)

  • The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach

    The investigators will measure the perioperative complications of VATS approach in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.

    30-90 days after surgery

  • The perioperative complications of robotic approach

    The investigators will measure the perioperative complications of robotic lung resection in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.

    from the surgery at 30-90 days after

  • The perioperative complications of the open approach

    The investigators will measure the perioperative complications of open approach in patients who received neoadjuvant chemo-immunotherapy. Complications will be categorized according to the Clavien-Dindo scale.

    30-90 days after surgery

Secondary Outcomes (6)

  • Duration of surgery

    from 30 days after surgery

  • Quality of lymphadenectomy

    from 30 days after surgery

  • Conversion rate

    from 30 days after surgery

  • Radicality of the resection

    from 30 days after surgery

  • Oncological treatment

    from 30 days after surgery

  • +1 more secondary outcomes

Study Arms (3)

Robotic Approach

Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent robotic lung resection

video-assisted thoracoscopic surgery (VATS) Approach

Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent video-assisted thoracoscopic surgery (VATS) lung resection

Open Approach

Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent open lung resection

Eligibility Criteria

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

Patients with diagnosed locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent lung resection from 01-01-2016 to 31-03-2024 by robotic, video-assisted thoracoscopic (VATS), and open approaches after receiving neoadjuvant chemo-immunotherapy.

You may qualify if:

  • Diagnosis of clinical or pathological stage IIB (T1-2, hilar N1, M0) and III (any T, N1-2, M0) NSCLC surgically treated with robotic, VATS and open approach with radical intent from 1st of January 2016 to 31st of March 2024
  • Received neoadjuvant chemo-immunotherapy or immunotherapy alone
  • Age \>= 18 years old at the moment of surgery

You may not qualify if:

  • Age \<18 years old at the moment of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Baptist Health South Florida

Miami, Florida, 33176, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

RECRUITING

Scientific Institute Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Regina Elena National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Pierluigi Novellis, Medical Doctor

CONTACT

0226437202novellis.pierluigi@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

September 30, 2024

Primary Completion

February 15, 2025

Study Completion

October 15, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

IT(3)US(3)