AchalasiaNCT03546998
Epidermoid Cancer Development in Esophageal Achalasia
An observational study of Achalasia and Epidermoid Carcinoma, run by Sandro Mattioli at 1 site in Italy.
Trial summary
Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Achalasia, Epidermoid Carcinoma
- What is being tested?
- Clinical instrumental examinations
- How many people
- 681 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 1973to 31 Dec 2025
- How long will I take part?
- 25 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 681 patients admitted at the division of Clinica Chirurgica II of the University of Bologna from 1973 and undergone surgery, pneumatic dilations or medical therapy for esophageal achalasia.
Who may be able to join
- diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry
Who cannot join
- pseudoachalasia
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Division of Thoracic Surgery Maria Cecilia Hospital
Cotignola, RA
Sandro Mattioli, MD, +39 051-6364643, sandro.mattioli@unibo.it
Marialuisa Lugaresi, MD, 0039 0512144643, marialuisa.lugaresi2@unibo.it
About this study
Official title: Incidence and Risk Factors for Development of Epidermoid Carcinoma in Esophageal Achalasia
Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.
Read the detailed description
In order to define incidence and risk factors for epidermoid carcinoma 681 patients affected by esophageal achalasia observed since 1973 were followed up with no time limits according to a prospective follow-up protocol. The local institutional review board approved using the database from the division of thoracic surgery for research purposes. Clinical, radiological and endoscopic data of achalasia patients were collected and analyzed.
- Conditions
- Achalasia, Epidermoid Carcinoma
- Being tested
- Clinical instrumental examinations
- Keywords
- epidermoid carcinoma, esophageal achalasia, risk factors
- Medical subject headings
- Esophageal Achalasia, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical instrumental examinationsDiagnostic test
Achalasia patients were periodically submitted to clinical assessment, barium swallow (esophageal diameter and residual barium column were measured), endoscopy. Mucosal esophageal biopsies were taken in order to diagnose dysplasia or epidermoid carcinoma.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of epidermoid carcinoma of the esophagus
Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy
Measured: 1 year
Secondary outcomes (1)
Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux
Result of achalasia treatment assessed by means of semiquantitative grading scales of dysphagia and gastro-esophageal reflux
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Jan 1973
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies 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
- 681 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- Sandro Mattioli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sandro Mattioli, University of Bologna
- Investigators
- Sandro Mattioli, MD, Principal investigator, Department of Medical and Surgical Sciences-Alma Mater Studiorum-Università di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546998
- Sponsor's protocol ID
- Epidermoid cancer in achalasia
- Status last verified
- May 2018
- First submitted
- 27 Apr 2018
- Last updated
- 6 Jun 2018
- Results posted
- 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 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Development of Epidermoid Carcinoma in Esophageal Achalasia
- ClinicalTrials.gov ID
- NCT03546998
- Acronym / sponsor ID
- Epidermoid cancer in achalasia
- Conditions
- Achalasia, Epidermoid Carcinoma
- Keywords
- epidermoid carcinoma, esophageal achalasia, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 681 participants (estimated)
- Lead sponsor
- Sandro MattioliUniversity, hospital or other
- Study start
- 1 Jan 1973 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jun 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.
Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.
Detailed description
In order to define incidence and risk factors for epidermoid carcinoma 681 patients affected by esophageal achalasia observed since 1973 were followed up with no time limits according to a prospective follow-up protocol. The local institutional review board approved using the database from the division of thoracic surgery for research purposes. Clinical, radiological and endoscopic data of achalasia patients were collected and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 681 patients admitted at the division of Clinica Chirurgica II of the University of Bologna from 1973 and undergone surgery, pneumatic dilations or medical therapy for esophageal achalasia.
Key inclusion criteria (1 listed)
- diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry
Key exclusion criteria (1 listed)
- pseudoachalasia
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 |
|---|---|---|
| Clinical instrumental examinationsAchalasia patients were periodically submitted to clinical assessment, barium swallow (esophageal diameter and residual barium column were measured), endoscopy. Mucosal esophageal biopsies were taken in order to diagnose dysplasia or epidermoid carcinoma. | Diagnostic test | – |
Primary outcome
Detection of epidermoid carcinoma of the esophagus
Time frame: 1 year
Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy
1 secondary outcome
Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: No
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Achalasia
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.
Sandro Mattioli, MD principal investigator
Department of Medical and Surgical Sciences-Alma Mater Studiorum-Università di Bologna
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 Achalasia and Epidermoid Carcinoma, run by Sandro Mattioli at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Jun 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandro Mattioli, MD (0039 0512144643, sandro.mattioli@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of epidermoid carcinoma of the esophagus (time frame: 1 year). 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 6 Jun 2018.