Solid CancerENDoRANCT07051161
Impact of Interventional Endoscopy on Quality of Life in Patients With Acute Respiratory Distress Due to Tumor Compression or Obstruction of the Lower Respiratory Tract
An observational study of Solid Cancer and Bronchial Endoscopy, run by University Hospital, Grenoble.
Trial summary
Bronchoscopic endoscopy has shown its effectiveness and reliability for the treatment (desobstruction or prothesis) of tumor-induced bronchial obstructions, particularly in the first few weeks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Cancer, Bronchial Endoscopy, Therapeutic Bronchofiberscopy
- What is being tested?
- bronchoscope
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Dec 2026
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inclusion Criteria: * >18 years old * tumoral tracheobronchial obstruction and/or compression * proven solid cancer or suspicion * Acute respiratory distress (at least one of the 5): * RR : ≥25/min * Sign of respiratory struggle * Sign of respiratory failure * Oxygen therapy ≥5L/min * Ventilatory support (NIV, OHD or IT) : * Indication for therapeutic interventional endoscopy * No guardianship or curatorship * Non-hematological tumor Exclusion Criteria: * Minors * patients with neurological disabilities unable to understand and respond to the questionnaire * patients under guardianship or curatorship
Who may be able to join
- >18 years old
- tumoral tracheobronchial obstruction and/or compression
- proven solid cancer or suspicion
- Acute respiratory distress (at least one of the 5):
- RR : ≥25/min
- Sign of respiratory struggle
Show all 12Show fewer
- Sign of respiratory failure
- Oxygen therapy ≥5L/min
- Ventilatory support (NIV, OHD or IT) :
- Indication for therapeutic interventional endoscopy
- No guardianship or curatorship
- Non-hematological tumor
Who cannot join
- Minors
- patients with neurological disabilities unable to understand and respond to the questionnaire
- patients under guardianship or curatorship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Bronchoscopic endoscopy has shown its effectiveness and reliability for the treatment (desobstruction or prothesis) of tumor-induced bronchial obstructions, particularly in the first few weeks. The presence of a lower airway prosthesis can lead to device obstruction requiring daily inhaled fluidification, bacterial colonization, migration of the prosthesis, or the appearance of obstructive or hemorrhagic granulomas.
The aim of this study is to evaluate the quality of life of patients after endobronchial treatment.
It is a prospective, descriptive, and multicentric (national) study. The main objective is to compare the total score on the Saint-George questionnaire at J7 of the interventional endoscopy compared to before the procedure.
- Being tested
- bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopeProcedure or surgery
Also called desobstruction of lower respiratory tract
procedure performed by bronchoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Saint George Score (quality of life)
Difference between Saint-George score at inclusion and Day 7.
The scores for each dimension range from 0 to 100, with a score of 100 indicating excellent health.
Measured: At inclusion, and 7 days after therapeutic bronchoscopy
Secondary outcomes (6)
Saint-George and SF-12 (12-Item Short-Form Health Survey) score
Difference of these scores between inclusion and Day 30
The scores for each dimension of the Saint-George score range from 0 to 100, with a score of 100 indicating excellent health.
The SF-12 score ranges from 1 to 60, with a score of 60 indicating very poor quality of life.
Measured: at inclusion and Day 30
ECOG-performance Status
It ranges from 0 (fully active) to 5 (dead).
Measured: inclusion and Day 30
Duration of ventilatory support (mechanical ventilation, non-invasive ventilation, high-flow oxygen)
Measured: During the 30 first days from intervention
hospitalization duration
Measured: During the 30 first days from intervention
anti-tumoral treatment
initiation or continuation of anti-tumour treatment (radiotherapy, chemotherapy, immunotherapy, targeted therapy)
Measured: During the 30 first days from intervention
survival
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051161
- Sponsor's protocol ID
- 38RC24.0408
- Other IDs
- 2024-A02698-39
- Acronym
- ENDoRA
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roy P, Fournier C, Barnestein R, Wallyn F, Bourinet V, Briault A, Camuset J, Cellerin L, Crutu A, Dewolf M, Egenod T, Favrolt N, Heluain V, Lorut C, Mangiapan G, Schlossmasscher P, Toublanc B, Usturoi D, Legodec J, Vergnon JM, Pajiep Chapda MC, Dutau H, Guibert N. Outcomes of Therapeutic Bronchoscopy in Malignant Airway Obstruction Causing Acute Respiratory Failure. Ann Am Thorac Soc. 2024 May;21(5):833-837. doi: 10.1513/AnnalsATS.202311-943RL. No abstract available.
PubMed 38391185Roy P, Roy P, Amari L, Laroumagne S, Legodec J, Fournier C, Cellerin L, Lorut C, Gonin F, Vergnon JM, Egenod T, Favrolt N, Schlossmacher P, Bourinet V, Perrot L, Lachkar S, Camuset J, Briault A, Degot T, Gut-Gobert C, Mangiapan G, Jasnot JY, Briens E, Crutu A, Marceau A, Toublanc B, Dewolf M, Dutilh J, Germain N, Tronchetti J, Astoul P, Guibert N, Dutau H. Predictive Factors of Clinical Success of Therapeutic Bronchoscopy in Malignant Central Airway Obstruction: Results from the EpiGETIF Registry. Respiration. 2025;104(9):667-677. doi: 10.1159/000545568. Epub 2025 Apr 4.
PubMed 40188807
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Interventional Endoscopy on Quality of Life in Patients With Acute Respiratory Distress Due to Tumor Compression or Obstruction of the Lower Respiratory Tract
- ClinicalTrials.gov ID
- NCT07051161
- Acronym / sponsor ID
- ENDoRA / 38RC24.0408
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Jul 2025 (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.
Bronchoscopic endoscopy has shown its effectiveness and reliability for the treatment (desobstruction or prothesis) of tumor-induced bronchial obstructions, particularly in the first few weeks. The presence of a lower airway prosthesis can lead to device obstruction requiring daily inhaled fluidification, bacterial colonization, migration of the prosthesis, or the appearance of obstructive or hemorrhagic granulomas.
The aim of this study is to evaluate the quality of life of patients after endobronchial treatment.
It is a prospective, descriptive, and multicentric (national) study. The main objective is to compare the total score on the Saint-George questionnaire at J7 of the interventional endoscopy compared to before the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion Criteria: * >18 years old * tumoral tracheobronchial obstruction and/or compression * proven solid cancer or suspicion * Acute respiratory distress (at least one of the 5): * RR : ≥25/min * Sign of respiratory struggle * Sign of respiratory failure * Oxygen therapy ≥5L/min * Ventilatory support (NIV, OHD or IT) : * Indication for therapeutic interventional endoscopy * No guardianship or curatorship * Non-hematological tumor Exclusion Criteria: * Minors * patients with neurological disabilities unable to understand and respond to the questionnaire * patients under guardianship or curatorship
Key inclusion criteria (12 listed)
- >18 years old
- tumoral tracheobronchial obstruction and/or compression
- proven solid cancer or suspicion
- Acute respiratory distress (at least one of the 5):
- Indication for therapeutic interventional endoscopy
Key exclusion criteria (3 listed)
- Minors
- patients with neurological disabilities unable to understand and respond to the questionnaire
- patients under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoscopeAlso: desobstruction of lower respiratory tractprocedure performed by bronchoscopy | Procedure or surgery | – |
Primary outcome
Saint George Score (quality of life)
Time frame: At inclusion, and 7 days after therapeutic bronchoscopy
Difference between Saint-George score at inclusion and Day 7. The scores for each dimension range from 0 to 100, with a score of 100 indicating excellent health.
6 secondary outcomes
Saint-George and SF-12 (12-Item Short-Form Health Survey) score
Time frame: at inclusion and Day 30
ECOG-performance Status
Time frame: inclusion and Day 30
Duration of ventilatory support (mechanical ventilation, non-invasive ventilation, high-flow oxygen)
Time frame: During the 30 first days from intervention
hospitalization duration
Time frame: During the 30 first days from intervention
anti-tumoral treatment
Time frame: During the 30 first days from intervention
survival
Time frame: through study completion, an average of 1 year
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 4 Jul 2025.
- Background: PubMed 38391185Roy P, Fournier C, Barnestein R, Wallyn F, Bourinet V, Briault A, Camuset J, Cellerin L, Crutu A, Dewolf M, Egenod T, Favrolt N, Heluain V, Lorut C, Mangiapan G, Schlossmasscher P, Toublanc B, Usturoi D, Legodec J, Vergnon JM, Pajiep Chapda MC, Dutau H, Guibert N. Outcomes of Therapeutic Bronchoscopy in Malignant Airway Obstruction Causing Acute Respiratory Failure. Ann Am Thorac Soc. 2024 May;21(5):833-837. doi: 10.1513/AnnalsATS.202311-943RL. No abstract available.
- Background: PubMed 40188807Roy P, Roy P, Amari L, Laroumagne S, Legodec J, Fournier C, Cellerin L, Lorut C, Gonin F, Vergnon JM, Egenod T, Favrolt N, Schlossmacher P, Bourinet V, Perrot L, Lachkar S, Camuset J, Briault A, Degot T, Gut-Gobert C, Mangiapan G, Jasnot JY, Briens E, Crutu A, Marceau A, Toublanc B, Dewolf M, Dutilh J, Germain N, Tronchetti J, Astoul P, Guibert N, Dutau H. Predictive Factors of Clinical Success of Therapeutic Bronchoscopy in Malignant Central Airway Obstruction: Results from the EpiGETIF Registry. Respiration. 2025;104(9):667-677. doi: 10.1159/000545568. Epub 2025 Apr 4.
- Individual participant dataSharing planned: No
Related trials for Solid Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Cancer and Bronchial Endoscopy, run by University Hospital, Grenoble.
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 12 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: opening soon, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Anne-Claire Toffart, MD-PhD (+33476766831, atoffart@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saint George Score (quality of life) (time frame: At inclusion, and 7 days after therapeutic bronchoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07051161, which also lists 2 linked publications.
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 4 Jul 2025.