NCT02311712

Brief Summary

The aim of this study is to assess the effects of implementation of a non-endoscopic esophageal cancer-screening program on outcomes of interest in an asymptomatic high-risk population in Golestan Province, Iran. Study population will be recruited in two arms. In the intervention arm, cytological examination of the esophagus will be performed using a capsule sponge device. Subjects in the control arm will receive no intervention. All participants will be followed for 5 years. The outcomes of interest, including the incidence of esophageal cancer as well as mortality rates, will be compared between the two groups.

Trial Health

50
Monitor

Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
12,000

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Dec 2016

Longer than P75 for not_applicable

Status
suspended

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 Progress73%
Dec 2016Dec 2029

First Submitted

Initial submission to the registry

December 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
2 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Expected
Last Updated

April 16, 2025

Status Verified

April 1, 2024

Enrollment Period

9 years

First QC Date

December 3, 2014

Last Update Submit

April 11, 2025

Conditions

Esophageal Cancer

Keywords

Esophageal cancerEarly detectionCytological examination

Outcome Measures

Primary Outcomes (3)

  • Histologically-confirmed esophageal squamous cell carcinoma

    Number of participants with Histologically-confirmed esophageal squamous cell carcinoma will be identified in both intervention and control arms

    5 years

  • Death from Esophageal Squamous Cell Carcinoma

    Number of Death from Esophageal Squamous Cell Carcinoma will be identified in both intervention and control arms

    5 years

  • Death from all causes

    Number of Death from all causes will be identified in both intervention and control arms

    5 years

Secondary Outcomes (3)

  • Histologically-confirmed esophageal adenocarcinoma

    5 years

  • Histologically-confirmed gastric cardia adenocarcinoma

    5 years

  • Change in Quality of life

    5 years

Study Arms (2)

Capsule sponge

ACTIVE COMPARATOR

Capsule sponge cytology examination coupled with H\&E staining analysed for the presence of atypia and p53 immunohistochemistry

Device: Capsule sponge

Control

NO INTERVENTION

No intervention

Interventions

Capsule spongeDEVICE

Capsule sponge cytology examination coupled with H\&E staining analysed for the presence of atypia and p53 immunohistochemistry

Capsule sponge

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants of Golestan Cohort study with age higher than 50 years.

You may not qualify if:

  • Subjects with a history of malignant disease, liver cirrhosis, or chronic renal failure will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Lyon, France: International Agency for Research on Cancer; 2013.

    BACKGROUND

  • Mahboubi E, Kmet J, Cook PJ, Day NE, Ghadirian P, Salmasizadeh S. Oesophageal cancer studies in the Caspian Littoral of Iran: the Caspian cancer registry. Br J Cancer. 1973 Sep;28(3):197-214. doi: 10.1038/bjc.1973.138.

    PMID: 4743904BACKGROUND

  • Ghasemi-Kebria F, Roshandel G, Semnani S, Shakeri R, Khoshnia M, Naeimi-Tabiei M, Merat S, Malekzadeh R. Marked increase in the incidence rate of esophageal adenocarcinoma in a high-risk area for esophageal cancer. Arch Iran Med. 2013 Jun;16(6):320-3.

    PMID: 23725063BACKGROUND

  • Roshandel G, Khoshnia M, Sotoudeh M, Merat S, Etemadi A, Nickmanesh A, Norouzi A, Pourshams A, Poustchi H, Semnani S, Ghasemi-Kebria F, Noorbakhsh R, Abnet C, Dawsey SM, Malekzadeh R. Endoscopic screening for precancerous lesions of the esophagus in a high risk area in Northern Iran. Arch Iran Med. 2014 Apr;17(4):246-52.

    PMID: 24724600BACKGROUND

  • Etemadi A, Abnet CC, Golozar A, Malekzadeh R, Dawsey SM. Modeling the risk of esophageal squamous cell carcinoma and squamous dysplasia in a high risk area in Iran. Arch Iran Med. 2012 Jan;15(1):18-21.

    PMID: 22208438BACKGROUND

  • Pan QJ, Roth MJ, Guo HQ, Kochman ML, Wang GQ, Henry M, Wei WQ, Giffen CA, Lu N, Abnet CC, Hao CQ, Taylor PR, Qiao YL, Dawsey SM. Cytologic detection of esophageal squamous cell carcinoma and its precursor lesions using balloon samplers and liquid-based cytology in asymptomatic adults in Llinxian, China. Acta Cytol. 2008 Jan-Feb;52(1):14-23. doi: 10.1159/000325430.

    PMID: 18323271BACKGROUND

  • Taylor PR, Abnet CC, Dawsey SM. Squamous dysplasia--the precursor lesion for esophageal squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 2013 Apr;22(4):540-52. doi: 10.1158/1055-9965.EPI-12-1347.

    PMID: 23549398BACKGROUND

  • Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T Jr, Young N; Forum Group Members; Bethesda 2001 Workshop. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002 Apr 24;287(16):2114-9. doi: 10.1001/jama.287.16.2114.

    PMID: 11966386BACKGROUND

  • Roshandel G, Sadjadi A, Aarabi M, Keshtkar A, Sedaghat SM, Nouraie SM, Semnani S, Malekzadeh R. Cancer incidence in Golestan Province: report of an ongoing population-based cancer registry in Iran between 2004 and 2008. Arch Iran Med. 2012 Apr;15(4):196-200.

    PMID: 22424034BACKGROUND

  • Roshandel G, Merat S, Sotoudeh M, Khoshnia M, Poustchi H, Lao-Sirieix P, Malhotra S, O'Donovan M, Etemadi A, Nickmanesh A, Pourshams A, Norouzi A, Debiram I, Semnani S, Abnet CC, Dawsey SM, Fitzgerald RC, Malekzadeh R. Pilot study of cytological testing for oesophageal squamous cell dysplasia in a high-risk area in Northern Iran. Br J Cancer. 2014 Dec 9;111(12):2235-41. doi: 10.1038/bjc.2014.506. Epub 2014 Sep 23.

    PMID: 25247319BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Reza Malekzadeh, MD

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 8, 2014

Study Start

December 1, 2016

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2029

Last Updated

April 16, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share