- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03723499
Endoscopic Treatment of Bronchial Carcinoid Tumors
October 26, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.
Study Overview
Detailed Description
The objective of this study is to evaluate the feasibility and therapeutic method of endoscopic treatment of bronchial carcinoid tumors.
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Étienne, France, 42055
- CHU de Saint-Etienne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients treated by endoscopic approach for a carcinoid tumor will be included.
Description
Inclusion Criteria:
- Patients treated by endoscopic approach for a carcinoid tumor at the University Hospital Centre of Saint-Etienne between November 1995 to December 2017.
Exclusion Criteria:
- Patients treated for a recurrence of carcinoid tumor.
- Patients with metastatic disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
endoscopic treatment
Patient with endoscopic treatment will be included.
Some medical data collection by medical record will be collected.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete endoscopic treatment
Time Frame: Month 1
|
patients who have a complete endoscopic treatment
|
Month 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type of endoscopic method used
Time Frame: Month 1
|
Analysis type of endoscopic method used.
|
Month 1
|
Tumor localization
Time Frame: Month 1
|
Analysis the tumor localization.
|
Month 1
|
Deadline before recurrence
Time Frame: 10 years
|
Analysis the deadline before recurrence of the tumor.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jean-Michel VERGNON, PhD, CHU Saint-Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 1995
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
October 26, 2018
First Submitted That Met QC Criteria
October 26, 2018
First Posted (Actual)
October 29, 2018
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 26, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBN812018/CHUSTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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