NCT03546998

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
681

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1973

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1973

Completed
45.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

53 years

First QC Date

April 27, 2018

Last Update Submit

May 23, 2018

Conditions

Keywords

epidermoid carcinomaesophageal achalasiarisk factors

Outcome Measures

Primary Outcomes (1)

  • Detection of epidermoid carcinoma of the esophagus

    Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy

    1 year

Secondary Outcomes (1)

  • Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux

    1 year

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • pseudoachalasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Thoracic Surgery Maria Cecilia Hospital

Cotignola, RA, Italy

RECRUITING

MeSH Terms

Conditions

Esophageal AchalasiaCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Study Officials

  • Sandro Mattioli, MD

    Department of Medical and Surgical Sciences-Alma Mater Studiorum-Università di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandro Mattioli, MD

CONTACT

Marisaluisa Lugaresi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
25 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Sandro Mattioli

Study Record Dates

First Submitted

April 27, 2018

First Posted

June 6, 2018

Study Start

January 1, 1973

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 6, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations