Lung CancerELDERLYNCT06496386
Robotic Assisted Major Lung Resection in Elderly Patients
An observational study of Lung Cancer, run by Scientific Institute San Raffaele at 2 sites in Italy.
Trial summary
The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 386 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Sep 2024to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the study will focus on the population of subjects undergoing lung resection with the DaVinci surgical platform from May 2015 to December 2022. The anatomical resections considered will be segmentectomy, lobectomy, bilobectomy or pneumonectomy using robotic system.
Who may be able to join
- Age >18 years at the moment of surgery
- Suspected or confirmed diagnosis of lung cancer
- The patient can be candidate in terms of cardiac, kidney, liver and respiratory function the primary pathology is under control or controllable
- Absence of extrapulmonary metastases that are not controlled or controllable
- All procedures included use of DaVinci robot system
Who cannot join
- Age < 18 years at the moment of surgery
- Patients who cannot undergo surgery, as they do not meet the conditions outlined above
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Scientific Institute Ospedale San Raffaele
Milan, 20132
Pierluigi Novellis, MD, +39022643 ext. 7202
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milan, 20089
Giuseppe Marulli, MD, giuseppe.marulli@hunimed.eu
About this study
Official title: Robotic Assisted Major Lung Resection in Elderly Patients: Results From a Retrospective Study
The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers.
There are no risks for the patients, as this is a retrospective data collection.
Read the detailed description
The investigators will recruit all patients who underwent major lung resection (segmentectomy, lobectomy, bilobectomy, or pneumonectomy using a robotic system) from May 2015 to December 2022.
Patients are divided into two groups: older than 80 years (case- very elderly patients) and younger than 80 years (control- elderly).
the aim: Minimally invasive techniques such as robot-assisted thoracoscopic surgery (RATS) can potentially reduce surgical trauma and therefore prove particularly beneficial for elderly patients.
- Conditions
- Lung Cancer
- Keywords
- robot-assisted thoracoscopic surgery, lung resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| very elderly patients | patients older than 80 years | |
| elderly patients | patients younger than 80 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
The perioperative complications
the investigators will measure the perioperative complications of robotic lung resection in patients with 80 or more than 80 years (very elderly patients) compared to those with less than 80 years. Complications will be categorized according to the Clavien-Dindo scale.
Measured: from the surgery at 30-90 days after
spirometry tests
the investigators will measure the pre-operative respiratory function (Forced expiratory volume (FEV) , forced vital capacity (FVC)), in the two groups .
Measured: from hospitalizzation to the discharge date at maximum one week
Postoperative hospital stay
the investigators will measure the post-operative hospital stay in days in the two groups.
Measured: from hospitalizzation to the discharge date at maximum one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start30 Sep 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierluigi Novellis, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496386
- Sponsor's protocol ID
- CET 234-2024
- Acronym
- ELDERLY
- Status last verified
- Nov 2024
- First submitted
- 28 Jun 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted Major Lung Resection in Elderly Patients: Results From a Retrospective Study
- ClinicalTrials.gov ID
- NCT06496386
- Acronym / sponsor ID
- ELDERLY / CET 234-2024
- Conditions
- Lung Cancer
- Keywords
- robot-assisted thoracoscopic surgery, lung resection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers.
There are no risks for the patients, as this is a retrospective data collection.
Detailed description
The investigators will recruit all patients who underwent major lung resection (segmentectomy, lobectomy, bilobectomy, or pneumonectomy using a robotic system) from May 2015 to December 2022.
Patients are divided into two groups: older than 80 years (case- very elderly patients) and younger than 80 years (control- elderly).
the aim: Minimally invasive techniques such as robot-assisted thoracoscopic surgery (RATS) can potentially reduce surgical trauma and therefore prove particularly beneficial for elderly patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| very elderly patients | – | –patients older than 80 years |
| elderly patients | – | –patients younger than 80 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study will focus on the population of subjects undergoing lung resection with the DaVinci surgical platform from May 2015 to December 2022. The anatomical resections considered will be segmentectomy, lobectomy, bilobectomy or pneumonectomy using robotic system.
Key inclusion criteria (5 listed)
- Age >18 years at the moment of surgery
- Suspected or confirmed diagnosis of lung cancer
- The patient can be candidate in terms of cardiac, kidney, liver and respiratory function the primary pathology is under control or controllable
- Absence of extrapulmonary metastases that are not controlled or controllable
- All procedures included use of DaVinci robot system
Key exclusion criteria (2 listed)
- Age < 18 years at the moment of surgery
- Patients who cannot undergo surgery, as they do not meet the conditions outlined above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The perioperative complications
Time frame: from the surgery at 30-90 days after
the investigators will measure the perioperative complications of robotic lung resection in patients with 80 or more than 80 years (very elderly patients) compared to those with less than 80 years. Complications will be categorized according to the Clavien-Dindo scale.
spirometry tests
Time frame: from hospitalizzation to the discharge date at maximum one week
the investigators will measure the pre-operative respiratory function (Forced expiratory volume (FEV) , forced vital capacity (FVC)), in the two groups .
Postoperative hospital stay
Time frame: from hospitalizzation to the discharge date at maximum one week
the investigators will measure the post-operative hospital stay in days in the two groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Related trials for Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Scientific Institute San Raffaele at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierluigi Novellis, MD (0226437202 ext. +39, novellis.pierluigi@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The perioperative complications (time frame: from the surgery at 30-90 days after). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.