Esophageal CancerNCT00339742
Stomach and Esophageal Cancers in Northern Iran
An observational study of Esophageal Cancer, run by National Cancer Institute (NCI) at 1 site in Iran.
Trial summary
This study, sponsored jointly by the National Cancer Institute and the Tehran University of Medical Sciences, will explore the causes of cancers of the stomach and esophagus (the tube that runs between the mouth and the stomach) in Northern Iran. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Esophageal Cancer
- How many people
- 1,163 participants
- Where
- 1 siteIran
- Study dates
- 25 Mar 2003to 13 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have histologically confirmed esophageal squamous cell carcinoma of the esophagus and consent to join the study were enrolled as cases. There were two control groups in this study, one selected from the neighborhood of case subjects and one from the patients referred to Atrak Clinic who do not have cancer. The neighborhood control group served as the primary control group.
Who may be able to join
- Cases:
- Cases will be recruited and studied in Atrak Clinic, in Gonbad City.
- All patients referred to Atrak Clinic suspected to have EC.
- Patients 30 years of age or above from Gonbad, Minodasht, Kalaleh, Ramyan, Azad-Shahr, Maraveh-Tappeh, and the surrounding villages who have a histopathological diagnosis confirming ESCC and who consent to join the study will be enrolled as cases.
- Controls:
- Controls will be recruited into one of the four hospitals of the city (Shohada, Motahary, Khatam, and Borzouieh), and in major referral outpatient clinic (Taleghani Clinic).
- Controls will be selected from the patient 30 years of age or above who are referred to the four hospitals of the city and Taleghani Clinic.
- Only patients referred for certain diseases will be selected as controls.
Who cannot join
- Controls:
- No association with tobacco or alcohol consumption, which are the main known risk factors for esophageal cancer (such as lung cancer, cardiovascular disease.
- Not causing major changes in diet or life-style for a long time (such as major GI diseases, chronic malignancies, diabetes).
Trial locations and contacts
1 site in 1 country.
Iran1 site
Digestive Disease Research Center, Tehran University of Medical Sciences
Tehran, 14117
About this study
Official title: Gastric and Esophageal Malignancies in Northern Iran (GEMINI): Phase I: Case-Control Study
This study, sponsored jointly by the National Cancer Institute and the Tehran University of Medical Sciences, will explore the causes of cancers of the stomach and esophagus (the tube that runs between the mouth and the stomach) in Northern Iran. This is a unique area of study for the following reasons:
- Some of the highest rates of esophageal cancer in the world have been reported in northeastern Iran 109 cases per 100,000 men and 175 cases per 100,000 women each year about 40 times higher than the rates of this cancer in the United States.
- In this area of Iran, unlike most areas of the world, the disease affects more women than men.
- Within 300 miles along the southern border of the Caspian Sea, the rates fall to 10 cases per 100,000 people per year.
Read more
The high rates of disease in this area, the unique geographic distribution of cases, and the exceptionally high rate in women make Northern Iran a promising site for studying esophageal and stomach cancers.
Patients 30 years of age and older who are referred to the upper gastrointestinal disease Atrak Clinic in Gonbad, Golestan Province, Iran, with suspected esophageal cancer may be eligible for this study. In addition, control subjects 30 years of age and older with certain specified diseases will be recruited from patients referred to four hospitals in Gonbad and to the Taleghani Clinic. After giving informed consent, all participants will undergo the following procedures:
- Interviews, including questions about age, ethnicity, education, and other demographic data; habits, such as tobacco, opium, and alcohol consumption; personal and family medical history; diet, with special attention to food preservation, cooking methods, and drinking water; physical activity; occupational and residential history; body measurements; signs and symptoms of upper gastrointestinal disease; oral hygiene; animal contact; transfusion history; and family socioeconomic status.
- Blood draw (15 milliliters, or 1 tablespoon) for genetic and chemical testing for markers that may predict who gets the disease.
- Hair and nail sampling to identify minerals or compounds whose exposure may be related to esophageal cancer.
- Endoscopy to evaluate the health of the esophagus and stomach. This test will be performed on all case patients and on control participants who give their permission. Before the examination, the subject will swallow a liquid that numbs the throat and may be given a medicine through a vein to promote drowsiness. The subject will then swallow a tube (endoscope) through which the doctor can look at the esophagus and stomach and take samples of tissue to look for disease. The tissue samples will be examined microscopically and will then be stored for possible future genetic or other testing related to diagnosing or determining the risk of esophageal cancer.
Read the detailed description
This case-control study (the first phase of the GEMINI project) is primarily focused on exploring the etiology (etiologies) of squamous cell carcinoma of the esophagus in northern Iran.
Esophageal and gastric cancers, together, are responsible for more than 1,000,000 annual deaths in the world. In 1996, cancers of the stomach and esophagus ranked first and second respectively, among the most frequent cancers in Iran, excluding skin cancers. Some of the highest incidence rates for esophageal cancer in the world have been reported in Northeastern Iran, in Northern Gonbad, with Age Standardized Rates (ASR) of 109/100,000 in men and 175/100,000 in women (1). These rates are approximately 40 times higher than those seen in the US. In this area, unlike most areas of the world, the incidence is higher in women than in men. Additionally, within 300 miles along the southern border of Caspian Sea, the rates fall to 10/100,000. The highest rates of EC in the world, a unique geographical distribution of cases, and an exceptionally high rate among women all make Northern Iran a very intriguing site for studying this disease.
An upper-GI referral clinic (Atrak Clinic) has already been established in Gonbad, Golestan Province, and DDRC researchers have conducted feasibility studies in this clinic. For the case-control study, local internists and other health system workers will refer suspected cases of esophageal cancer to the Clinic. All such patients will undergo endoscopy and biopsy for ascertainment of diagnosis. Patients who have histologically confirmed esophageal squamous cell carcinoma of the esophagus and consent to join the study will be enrolled as cases. There will be two control groups in this study, one selected from the neighborhood of case subjects and one from the patients referred to Atrak Clinic who do not have cancer. The neighborhood control group will serve as the primary control group. Both the cases and the controls will be interviewed and undergo collection of biological specimens including blood, hair and nails. Free (and optional) endoscopy will also be offered to the neighborhood controls. A four-year accrual of 300 cases, 600 neighborhood controls and 300 clinic controls is expected.
Environmental risk factors (including life-style, habits, and nutritional status) will be assessed through questionnaires and objective measurements in biological specimens. The role of genetic polymorphisms will be studies using genomic DNA from cases and controls. A subset of samples collected from cases and controls will be used to evaluate gene expression patterns, using microarray analysis, differences in serum protein patterns, using SELDI analysis.
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Case-Control Study, Environmental Risk Factors, Genetic Risk Factors
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinic Referral controls | Controls referred by the endoscopy clinic | |
| Esophageal Cancer cases | Histologically confirmed squamous cell cancer of the esophagus | |
| Neighborhood controls | Controls recruited from the neighborhood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Cancer
Patients who have histologically confirmed esophageal squamous cellcarcinoma of the esophagus and consent to join the study will be enrolled as cases.
Measured: At diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start25 Mar 2003
- Primary completion26 Mar 2010
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,163 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christian Abnet, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339742
- Sponsor's protocol ID
- 999903146
- Other IDs
- 03-C-N146
- Status last verified
- Dec 2020
- First submitted
- 19 Jun 2006
- Last updated
- 11 Dec 2020
- Results posted
- No
Publications
Abnet CC, Kamangar F, Islami F, Nasrollahzadeh D, Brennan P, Aghcheli K, Merat S, Pourshams A, Marjani HA, Ebadati A, Sotoudeh M, Boffetta P, Malekzadeh R, Dawsey SM. Tooth loss and lack of regular oral hygiene are associated with higher risk of esophageal squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3062-8. doi: 10.1158/1055-9965.EPI-08-0558.
PubMed 18990747Islami F, Pourshams A, Nasrollahzadeh D, Kamangar F, Fahimi S, Shakeri R, Abedi-Ardekani B, Merat S, Vahedi H, Semnani S, Abnet CC, Brennan P, Moller H, Saidi F, Dawsey SM, Malekzadeh R, Boffetta P. Tea drinking habits and oesophageal cancer in a high risk area in northern Iran: population based case-control study. BMJ. 2009 Mar 26;338:b929. doi: 10.1136/bmj.b929.
PubMed 19325180Islami F, Kamangar F, Nasrollahzadeh D, Aghcheli K, Sotoudeh M, Abedi-Ardekani B, Merat S, Nasseri-Moghaddam S, Semnani S, Sepehr A, Wakefield J, Moller H, Abnet CC, Dawsey SM, Boffetta P, Malekzadeh R. Socio-economic status and oesophageal cancer: results from a population-based case-control study in a high-risk area. Int J Epidemiol. 2009 Aug;38(4):978-88. doi: 10.1093/ije/dyp195. Epub 2009 May 4.
PubMed 19416955
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric and Esophageal Malignancies in Northern Iran (GEMINI): Phase I: Case-Control Study
- ClinicalTrials.gov ID
- NCT00339742
- Acronym / sponsor ID
- 999903146
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Case-Control Study, Environmental Risk Factors, Genetic Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,163 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 25 Mar 2003 (actual)
- Primary completion
- 26 Mar 2010 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study, sponsored jointly by the National Cancer Institute and the Tehran University of Medical Sciences, will explore the causes of cancers of the stomach and esophagus (the tube that runs between the mouth and the stomach) in Northern Iran. This is a unique area of study for the following reasons:
- Some of the highest rates of esophageal cancer in the world have been reported in northeastern Iran 109 cases per 100,000 men and 175 cases per 100,000 women each year about 40 times higher than the rates of this cancer in the United States.
- In this area of Iran, unlike most areas of the world, the disease affects more women than men.
- Within 300 miles along the southern border of the Caspian Sea, the rates fall to 10 cases per 100,000 people per year.
The high rates of disease in this area, the unique geographic distribution of cases, and the exceptionally high rate in women make Northern Iran a promising site for studying esophageal and stomach cancers.
Patients 30 years of age and older who are referred to the upper gastrointestinal disease Atrak Clinic in Gonbad, Golestan Province, Iran, with suspected esophageal cancer may be eligible for this study. In addition, control subjects 30 years of age and older with certain specified diseases will be recruited from patients referred to four hospitals in Gonbad and to the Taleghani Clinic. After giving informed consent, all participants will undergo the following procedures:
- Interviews, including questions about age, ethnicity, education, and other demographic data; habits, such as tobacco, opium, and alcohol consumption; personal and family medical history; diet, with special attention to food preservation, cooking methods, and drinking water; physical activity; occupational and residential history; body measurements; signs and symptoms of upper gastrointestinal disease; oral hygiene; animal contact; transfusion history; and family socioeconomic status.
- Blood draw (15 milliliters, or 1 tablespoon) for genetic and chemical testing for markers that may predict who gets the disease.
- Hair and nail sampling to identify minerals or compounds whose exposure may be related to esophageal cancer.
- Endoscopy to evaluate the health of the esophagus and stomach. This test will be performed on all case patients and on control participants who give their permission. Before the examination, the subject will swallow a liquid that numbs the throat and may be given a medicine through a vein to promote drowsiness. The subject will then swallow a tube (endoscope) through which the doctor can look at the esophagus and stomach and take samples of tissue to look for disease. The tissue samples will be examined microscopically and will then be stored for possible future genetic or other testing related to diagnosing or determining the risk of esophageal cancer.
Detailed description
This case-control study (the first phase of the GEMINI project) is primarily focused on exploring the etiology (etiologies) of squamous cell carcinoma of the esophagus in northern Iran.
Esophageal and gastric cancers, together, are responsible for more than 1,000,000 annual deaths in the world. In 1996, cancers of the stomach and esophagus ranked first and second respectively, among the most frequent cancers in Iran, excluding skin cancers. Some of the highest incidence rates for esophageal cancer in the world have been reported in Northeastern Iran, in Northern Gonbad, with Age Standardized Rates (ASR) of 109/100,000 in men and 175/100,000 in women (1). These rates are approximately 40 times higher than those seen in the US. In this area, unlike most areas of the world, the incidence is higher in women than in men. Additionally, within 300 miles along the southern border of Caspian Sea, the rates fall to 10/100,000. The highest rates of EC in the world, a unique geographical distribution of cases, and an exceptionally high rate among women all make Northern Iran a very intriguing site for studying this disease.
An upper-GI referral clinic (Atrak Clinic) has already been established in Gonbad, Golestan Province, and DDRC researchers have conducted feasibility studies in this clinic. For the case-control study, local internists and other health system workers will refer suspected cases of esophageal cancer to the Clinic. All such patients will undergo endoscopy and biopsy for ascertainment of diagnosis. Patients who have histologically confirmed esophageal squamous cell carcinoma of the esophagus and consent to join the study will be enrolled as cases. There will be two control groups in this study, one selected from the neighborhood of case subjects and one from the patients referred to Atrak Clinic who do not have cancer. The neighborhood control group will serve as the primary control group. Both the cases and the controls will be interviewed and undergo collection of biological specimens including blood, hair and nails. Free (and optional) endoscopy will also be offered to the neighborhood controls. A four-year accrual of 300 cases, 600 neighborhood controls and 300 clinic controls is expected.
Environmental risk factors (including life-style, habits, and nutritional status) will be assessed through questionnaires and objective measurements in biological specimens. The role of genetic polymorphisms will be studies using genomic DNA from cases and controls. A subset of samples collected from cases and controls will be used to evaluate gene expression patterns, using microarray analysis, differences in serum protein patterns, using SELDI analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinic Referral controls | – | –Controls referred by the endoscopy clinic |
| Esophageal Cancer cases | – | –Histologically confirmed squamous cell cancer of the esophagus |
| Neighborhood controls | – | –Controls recruited from the neighborhood |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have histologically confirmed esophageal squamous cell carcinoma of the esophagus and consent to join the study were enrolled as cases. There were two control groups in this study, one selected from the neighborhood of case subjects and one from the patients referred to Atrak Clinic who do not have cancer. The neighborhood control group served as the primary control group.
Key inclusion criteria (8 listed)
- Cases will be recruited and studied in Atrak Clinic, in Gonbad City.
- All patients referred to Atrak Clinic suspected to have EC.
- Patients 30 years of age or above from Gonbad, Minodasht, Kalaleh, Ramyan, Azad-Shahr, Maraveh-Tappeh, and the surrounding villages who have a histopathological diagnosis confirming ESCC and who consent to join the study will be enrolled as cases.
- Controls will be recruited into one of the four hospitals of the city (Shohada, Motahary, Khatam, and Borzouieh), and in major referral outpatient clinic (Taleghani Clinic).
- Controls will be selected from the patient 30 years of age or above who are referred to the four hospitals of the city and Taleghani Clinic.
Key exclusion criteria (3 listed)
- No association with tobacco or alcohol consumption, which are the main known risk factors for esophageal cancer (such as lung cancer, cardiovascular disease.
- Not causing major changes in diet or life-style for a long time (such as major GI diseases, chronic malignancies, diabetes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Esophageal Cancer
Time frame: At diagnosis
Patients who have histologically confirmed esophageal squamous cellcarcinoma of the esophagus and consent to join the study will be enrolled as cases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Background: PubMed 18990747Abnet CC, Kamangar F, Islami F, Nasrollahzadeh D, Brennan P, Aghcheli K, Merat S, Pourshams A, Marjani HA, Ebadati A, Sotoudeh M, Boffetta P, Malekzadeh R, Dawsey SM. Tooth loss and lack of regular oral hygiene are associated with higher risk of esophageal squamous cell carcinoma. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3062-8. doi: 10.1158/1055-9965.EPI-08-0558.
- Background: PubMed 19325180Islami F, Pourshams A, Nasrollahzadeh D, Kamangar F, Fahimi S, Shakeri R, Abedi-Ardekani B, Merat S, Vahedi H, Semnani S, Abnet CC, Brennan P, Moller H, Saidi F, Dawsey SM, Malekzadeh R, Boffetta P. Tea drinking habits and oesophageal cancer in a high risk area in northern Iran: population based case-control study. BMJ. 2009 Mar 26;338:b929. doi: 10.1136/bmj.b929.
- Background: PubMed 19416955Islami F, Kamangar F, Nasrollahzadeh D, Aghcheli K, Sotoudeh M, Abedi-Ardekani B, Merat S, Nasseri-Moghaddam S, Semnani S, Sepehr A, Wakefield J, Moller H, Abnet CC, Dawsey SM, Boffetta P, Malekzadeh R. Socio-economic status and oesophageal cancer: results from a population-based case-control study in a high-risk area. Int J Epidemiol. 2009 Aug;38(4):978-88. doi: 10.1093/ije/dyp195. Epub 2009 May 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Abnet, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by National Cancer Institute (NCI) at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal Cancer (time frame: At diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339742, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.