Epidermoid Cancer Development in Esophageal Achalasia | NCT03546998

Studies
Epidermoid Cancer Development in Esophageal Achalasia

NCT03546998

Sponsor

Sandro Mattioli

Status

Unknown status

Last Update Posted

Jun 6, 2018Actual

Enrollment

681Estimated

Phase

Not provided

Conditions

Achalasia
Epidermoid Carcinoma

Interventions

Clinical instrumental examinations

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1973Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Apr 27, 2018

First Submission Date that Met QC Criteria

May 23, 2018

First Posted Date

Jun 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2018

Last Update Posted Date

Jun 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

25 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

681Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical instrumental examinations	Diagnostic 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of epidermoid carcinoma of the esophagus	Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy	1 year

Secondary Outcomes

Measure	Description	Time Frame
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	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry

Exclusion Criteria:

pseudoachalasia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sandro Mattioli, MD	Contact	0039 0512144643		sandro.mattioli@unibo.it
Marisaluisa Lugaresi, MD	Contact	3356843779		marialuisa.lugaresi2@unibo.it

Overall Officials

Name	Affiliation	Role
Sandro Mattioli, MD	Department of Medical and Surgical Sciences-Alma Mater Studiorum-Università di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Thoracic Surgery Maria Cecilia Hospital	Recruiting	Cotignola	RA		Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004931	Esophageal Achalasia
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided