Carcinoid TumorNCT03723499
Endoscopic Treatment of Bronchial Carcinoid Tumors
An observational study of Carcinoid Tumor, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Carcinoid tumors of the lung are considered to be a low-grade malignancy. Surgical resection is considered the standard approach. Recent data has shown that a complete endoscopic treatment could be considered. An endoscopic treatment is can be a alternative to invasive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Tumor
- What is being tested?
- Medical data collection
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Nov 1995to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients treated by endoscopic approach for a carcinoid tumor will be included.
Who may be able to join
- Patients treated by endoscopic approach for a carcinoid tumor at the University Hospital Centre of Saint-Etienne between November 1995 to December 2017.
Who cannot join
- Patients treated for a recurrence of carcinoid tumor.
- Patients with metastatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Therapeutic Method of Endoscopic Treatment of Bronchial Carcinoid Tumors: 22 Years Experience of Saint-Etienne
Carcinoid tumors of the lung are considered to be a low-grade malignancy. Surgical resection is considered the standard approach. Recent data has shown that a complete endoscopic treatment could be considered. An endoscopic treatment is can be a alternative to invasive surgery.
Read the detailed description
The objective of this study is to evaluate the feasibility and therapeutic method of endoscopic treatment of bronchial carcinoid tumors.
- Conditions
- Carcinoid Tumor
- Being tested
- Medical data collection
- Keywords
- Carcinoid tumors, Endoscopic treatment, Recurrence
- Medical subject headings
- Carcinoid Tumor, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical data collectionOther
Medical data collection by medical record will be collected: demographics data, medical history, clinical symptoms, smoking, type of endoscopic method, complete treatment or not, type of surgeries if yes, anatomopathology of the injury and recurrence if yes
| Study group | Role | What they receive |
|---|---|---|
| endoscopic treatment | Patient with endoscopic treatment will be included. Some medical data collection by medical record will be collected. Receives: Other: Medical data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete endoscopic treatment
patients who have a complete endoscopic treatment
Measured: Month 1
Secondary outcomes (3)
Type of endoscopic method used
Analysis type of endoscopic method used.
Measured: Month 1
Tumor localization
Analysis the tumor localization.
Measured: Month 1
Deadline before recurrence
Analysis the deadline before recurrence of the tumor.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study startNov 1995
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid TumorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel VERGNON, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723499
- Sponsor's protocol ID
- IRBN812018/CHUSTE
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Therapeutic Method of Endoscopic Treatment of Bronchial Carcinoid Tumors: 22 Years Experience of Saint-Etienne
- ClinicalTrials.gov ID
- NCT03723499
- Acronym / sponsor ID
- IRBN812018/CHUSTE
- Conditions
- Carcinoid Tumor
- Keywords
- Carcinoid tumors, Endoscopic treatment, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Nov 1995 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Oct 2018 (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.
Carcinoid tumors of the lung are considered to be a low-grade malignancy. Surgical resection is considered the standard approach. Recent data has shown that a complete endoscopic treatment could be considered. An endoscopic treatment is can be a alternative to invasive surgery.
Detailed description
The objective of this study is to evaluate the feasibility and therapeutic method of endoscopic treatment of bronchial carcinoid tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopic treatment | – | Other: Medical data collectionPatient with endoscopic treatment will be included. Some medical data collection by medical record will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by endoscopic approach for a carcinoid tumor will be included.
Key inclusion criteria (1 listed)
- Patients treated by endoscopic approach for a carcinoid tumor at the University Hospital Centre of Saint-Etienne between November 1995 to December 2017.
Key exclusion criteria (2 listed)
- Patients treated for a recurrence of carcinoid tumor.
- Patients with metastatic disease.
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 |
|---|---|---|
| Medical data collectionMedical data collection by medical record will be collected: demographics data, medical history, clinical symptoms, smoking, type of endoscopic method, complete treatment or not, type of surgeries if yes, anatomopathology of the injury and recurrence if yes | Other | endoscopic treatment |
Primary outcome
Complete endoscopic treatment
Time frame: Month 1
patients who have a complete endoscopic treatment
3 secondary outcomes
Type of endoscopic method used
Time frame: Month 1
Tumor localization
Time frame: Month 1
Deadline before recurrence
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean-Michel VERGNON, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Carcinoid Tumor, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 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: finished, as of the sponsor's last update on 29 Oct 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete endoscopic treatment (time frame: Month 1). 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 29 Oct 2018.