Adrenal Gland DiseaseNCT03327142
EUS-guided FNA in the Study of the Adrenal Gland
An observational study of Adrenal Gland Disease and Adrenal Tumor, run by Hospital Universitari de Bellvitge.
Trial summary
To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG. National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Gland Disease, Adrenal Tumor
- What is being tested?
- Endoscopic Ultrasound-Guided FNA
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 8 Dec 2015to 30 Apr 2016
- 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: Nationwide. Mailing-invitation to Spanish Society of Digestive Endoscopy (SEED) partners. Participation: 17 Spanish centers.
Who may be able to join
- All adrenal gland (Left / Right) punctured by endoscopic ultrasound
Who cannot join
None listed.
About this study
Official title: EUS-guided FNA in the Study of the Adrenal Gland: National Retrospective Multicenter Study
To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG. National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS.
A review of 205 EUS-FNA of AG in 200 patients is included.
Read the detailed description
INTRODUCTION: The EUS has proven useful in the study and evaluation of the adrenal gland (AG) by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), in both the left and right glands.
OBJECTIVE: To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG.
MATERIALS AND METHODS: National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS. Variables reviewed: Demographic characteristics, clinical, extension studies, USE and pathological data. Comparison between variables; and estimation of multivariate logistic model for cytology, mortality and therapeutic change.
- Conditions
- Adrenal Gland Disease, Adrenal Tumor
- Being tested
- Endoscopic Ultrasound-Guided FNA
- Keywords
- Adrenal Gland, Endoscopic Ultrasound Guided FNA
- Medical subject headings
- Adrenal Gland Diseases, Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound-Guided FNADiagnostic test
Also called Endosonography
Endoscopic Ultrasound Guided Fine Needle Aspiration of Puncture of Adrenal Glands
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Measured: retrospective analysis form 2003 to 2016
Secondary outcomes (2)
number of adverse events related to the procedure
Measured: retrospective analysis, last 10 years
Predictors of malignancy
Predictors of malignancy and cyto-pathological correlation of the EUS-FNA with adrenal gland
Measured: retrospective analysis, last 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start8 Dec 2015
- Primary completion31 Jan 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal Gland DiseaseStudies 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
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOAN B GORNALS, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327142
- Sponsor's protocol ID
- AdrenalG EUS-Study
- Status last verified
- Aug 2017
- First submitted
- 29 Mar 2017
- Last updated
- 31 Oct 2017
- 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 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided FNA in the Study of the Adrenal Gland: National Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT03327142
- Acronym / sponsor ID
- AdrenalG EUS-Study
- Conditions
- Adrenal Gland Disease, Adrenal Tumor
- Keywords
- Adrenal Gland, Endoscopic Ultrasound Guided FNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 31 Oct 2017 (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.
To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG. National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS.
A review of 205 EUS-FNA of AG in 200 patients is included.
Detailed description
INTRODUCTION: The EUS has proven useful in the study and evaluation of the adrenal gland (AG) by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), in both the left and right glands.
OBJECTIVE: To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG.
MATERIALS AND METHODS: National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS. Variables reviewed: Demographic characteristics, clinical, extension studies, USE and pathological data. Comparison between variables; and estimation of multivariate logistic model for cytology, mortality and therapeutic change.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nationwide. Mailing-invitation to Spanish Society of Digestive Endoscopy (SEED) partners. Participation: 17 Spanish centers.
Key inclusion criteria (1 listed)
- All adrenal gland (Left / Right) punctured by endoscopic ultrasound
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Endoscopic Ultrasound-Guided FNAAlso: EndosonographyEndoscopic Ultrasound Guided Fine Needle Aspiration of Puncture of Adrenal Glands | Diagnostic test | – |
Primary outcome
Diagnostic accuracy
Time frame: retrospective analysis form 2003 to 2016
2 secondary outcomes
number of adverse events related to the procedure
Time frame: retrospective analysis, last 10 years
Predictors of malignancy
Time frame: retrospective analysis, last 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 31 Oct 2017.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Gland Disease and Adrenal Tumor, run by Hospital Universitari de Bellvitge.
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 0 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 31 Oct 2017. 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?
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?
Diagnostic accuracy (time frame: retrospective analysis form 2003 to 2016). 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 31 Oct 2017.