Clinical trial · Interventional
Non-endoscopic EC Screening Program in Northern Iran
Non-endoscopic Esophageal Cancer Screening Program in Northern Iran
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Waiting to receive capsule sponge device from the manufacturer.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capsule sponge | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Capsule sponge
- description
- Capsule sponge cytology examination coupled with H\&E staining analysed for the presence of atypia and p53 immunohistochemistry
- interventionNames
- Device: Capsule sponge
- type
- NO_INTERVENTION
- label
- Control
- description
- No intervention
Primary outcomes (3)
- measure
- Histologically-confirmed esophageal squamous cell carcinoma
- timeFrame
- 5 years
- description
- Number of participants with Histologically-confirmed esophageal squamous cell carcinoma will be identified in both intervention and control arms
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Participants of Golestan Cohort study with age higher than 50 years. Exclusion Criteria: * Subjects with a history of malignant disease, liver cirrhosis, or chronic renal failure will be excluded.
References
Publications (10)
- BACKGROUNDFerlay 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.
- BACKGROUNDMahboubi 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 4743904
- BACKGROUNDGhasemi-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 23725063
- BACKGROUNDRoshandel 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 24724600
- BACKGROUNDEtemadi 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 22208438
- BACKGROUNDPan 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 18323271
- BACKGROUNDTaylor 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.