Non Small Cell Lung CancerNCT07477158
Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The goal is to compare patient reported outcomes, such as dyspnea, physical functioning and quality of life, between minimally invasive segmentectomy and lobectomy for stage I NSCLC during the first year after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2023to 1 Dec 2027
- How long will I take part?
- 1 Year
- 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: Adult patients undergoing elective thoracic surgery at a tertiary referral hospital will be considered for inclusion. The study population will consist of patients scheduled for pulmonary resection for suspected or confirmed malignant lung disease.
Who may be able to join
- Patients with clinical stage I NSCLC who undergo segmentectomy or lobectomy with VATS or RATS.
Who cannot join
- Thoracic surgery in the previous year
- Neoadyuvant treatment
- Failure to complete preoperative questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Sara Fra, MD, 0034913369102, sarafrafernandez@gmail.com
Nicolás Moreno, PhD, 0034913368048, nicolas.moreno.hrc@gmail.com
About this study
Official title: Living After Lung Surgery: Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer
The goal is to compare patient reported outcomes, such as dyspnea, physical functioning and quality of life, between minimally invasive segmentectomy and lobectomy for stage I NSCLC during the first year after surgery.
The main questions it aims to answer are:
Read more
- Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have less postoperative dyspnea than patients that undergo lobectomy?
- Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo lobectomy?
- Do patients with stage I NSCLC that undergo VATS segmentectomy or lobectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo RATS segmentectomy or lobectomy?
Participants already undergoing surgical intervention as part of their regular medical care for resectable lung cancer will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Segmentectomy, Lobectomy, NSCLC, Lung Cancer, PROM, QoL, HRQoL
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, 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 |
|---|---|---|
| Segmentectomy | Patients with cI NSLSC that undergo minimally invasive segmentectomy | |
| Lobectomy | Patients with cI NSLSC that undergo minimally invasive lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative dyspnea
The postoperative dyspnea score will be calculated from the 33-35 items of the EORTC QLQ-LC29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 29) questionnaire and standardized to a 0-100 score. These items assess dyspnoea in three modalities: during rest, walking and climbing stairs in the preceding week. In each setting dyspnea is quantified from 1 (not at all short or breath) to 4 (very much short of breath), therefore a higher score indicates a higher level of dyspnea.
Measured: It will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
Secondary outcomes (2)
Quality-Adjusted Life Years (QALYs)
Quality-adjusted life years (QALYs) will be calculated by combining survival with health-related quality of life measured using the EuroQol 5-Dimension ( EQ-5D) Questionnaire questionnaire at predefined follow-up time points. Utility scores derived from EQ-5D responses will be used to estimate QALYs using the area-under-the-curve method over the study period. Utility scores typically range from values below 0 (health states considered worse than death) to 1 (perfect health), with higher scores indicating better health status.
Measured: Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
Physical Functioning
Physical functioning will be assessed using the Physical Functioning scale of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) questionnaire. This scale is calculated from items 1-5, which assess limitations in strenuous activities, walking long and short distances, the need to stay in bed or a chair during the day, and the need for assistance with basic daily activities. Scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual, with higher scores indicating better physical functioning (100 = best functioning, 0 = worst).
Measured: Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start10 Jul 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Fra Fernandez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Investigators
- Sara Fra, MD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477158
- Sponsor's protocol ID
- 073/26
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living After Lung Surgery: Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer
- ClinicalTrials.gov ID
- NCT07477158
- Acronym / sponsor ID
- 073/26
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Segmentectomy, Lobectomy, NSCLC, Lung Cancer, PROM, QoL, HRQoL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Mar 2026 (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 goal is to compare patient reported outcomes, such as dyspnea, physical functioning and quality of life, between minimally invasive segmentectomy and lobectomy for stage I NSCLC during the first year after surgery.
The main questions it aims to answer are:
- Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have less postoperative dyspnea than patients that undergo lobectomy?
- Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo lobectomy?
- Do patients with stage I NSCLC that undergo VATS segmentectomy or lobectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo RATS segmentectomy or lobectomy?
Participants already undergoing surgical intervention as part of their regular medical care for resectable lung cancer will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmentectomy | – | –Patients with cI NSLSC that undergo minimally invasive segmentectomy |
| Lobectomy | – | –Patients with cI NSLSC that undergo minimally invasive lobectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective thoracic surgery at a tertiary referral hospital will be considered for inclusion. The study population will consist of patients scheduled for pulmonary resection for suspected or confirmed malignant lung disease.
Key inclusion criteria (1 listed)
- Patients with clinical stage I NSCLC who undergo segmentectomy or lobectomy with VATS or RATS.
Key exclusion criteria (3 listed)
- Thoracic surgery in the previous year
- Neoadyuvant treatment
- Failure to complete preoperative questionnaires
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
Postoperative dyspnea
Time frame: It will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
The postoperative dyspnea score will be calculated from the 33-35 items of the EORTC QLQ-LC29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 29) questionnaire and standardized to a 0-100 score. These items assess dyspnoea in three modalities: during rest, walking and climbing stairs in the preceding week. In each setting dyspnea is quantified from 1 (not at all short or breath) to 4 (very much short of breath), therefore a higher score indicates a higher level of dyspnea.
2 secondary outcomes
Quality-Adjusted Life Years (QALYs)
Time frame: Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
Physical Functioning
Time frame: Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
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 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sara Fra, MD principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 1 inclusion and 3 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 Sara Fra, MD (0034913369102, sarafrafernandez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative dyspnea (time frame: It will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.). 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 19 Mar 2026.