NCT03066167

Brief Summary

This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the oesophagus and gastro-oesophageal junction and to the Swedish language.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

9.7 years

First QC Date

February 23, 2017

Last Update Submit

July 24, 2020

Conditions

Dysphagia, EsophagealEsophageal Cancer

Keywords

Cancer of the gastro-esophageal junctionWatson scoreOgilvie scoreGoldschmid scoreValidationQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Validation of dysphagia scores

    10-14 days

  • Translation of scores to the Swedish language

    10-14 days

Study Arms (2)

Patients

Patients with oesophageal cancer and dysphagia

Other: Validation of different dysphagia scores

Controls

Healthy Controls with no known dysphagia

Other: Validation of different dysphagia scores

Interventions

Validation of different dysphagia scoresOTHER
Also known as: Validation to the Swedish language
ControlsPatients

Eligibility Criteria

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

Patients with cancer in the oesophagus and as Controls, healthy volunteers.

You may qualify if:

  • Cancer in the gastro-esophageal junction or in the esophagus
  • Dysphagia
  • Ability to fill in the questionnaires
  • Written acceptance of the informed consent

You may not qualify if:

  • No consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Department, Sahlgrenska University Hospital

Gothenburg, Västra Götalandsregionen, 41345, Sweden

Location

MeSH Terms

Conditions

Deglutition DisordersEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2017

First Posted

February 28, 2017

Study Start

November 1, 2010

Primary Completion

July 23, 2020

Study Completion

July 23, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)