Esophageal CancerNCT00342472
Environmental and Biological Monitoring Pilot Study for Polycyclic Aromatic Hydrocarbons in Linxian, China
An observational study of Esophageal Cancer, run by National Cancer Institute (NCI) at 1 site in China.
Trial summary
The overall goal of this project is to determine whether polycyclic aromatic hydrocarbons (PAHs) are contributing to the high rate of esophageal cancer in Linxian, China. Esophageal cancer is one of the most fatal cancers worldwide with Linxian, China having one of the highest rates in the world. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 1998to 5 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two of the oldest individuals (a male and a female greater than 18 years of age) from each of 10-15 nonsmoking households from the high-risk region of Linxian, China and, to the extent that is possible, from appropriately age matched controls from a total of 20 nonsmoking individuals from the low-risk region of Gejiu, Yunnan province will be selected to participate.
Who may be able to join
- Two of the oldest individuals (a male and a female greater than 18 years of age) from each of 10-15 nonsmoking households from the high-risk region of Linxian, China and, to the extent that is possible, from appropriately age matched controls from a total of 20 nonsmoking individuals from the low-risk region of Gejiu, Yunnan province will be selected to participate.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of this project is to determine whether polycyclic aromatic hydrocarbons (PAHs) are contributing to the high rate of esophageal cancer in Linxian, China.
Esophageal cancer is one of the most fatal cancers worldwide with Linxian, China having one of the highest rates in the world. In the United States esophageal cancer causes approximately 10,000 deaths each year. It is the fourth most common cause of cancer death in black males and the eighth leading cause of cancer death in men of all races. Although several recent studies have identified some of the molecular changes associated with esophageal cancer, its prevention and treatment within high risk groups continues to be limited by our inability to identify specific etiologic agents.
Read more
Human exposure to PAHs, including benzo [a]pyrene (B[a]P), is associated with an increased rate of skin, lung, and upper GI tumors and also with an increased mortality from causes related to atherosclerosis. Evidence, including the preliminary results from histologic and food analysis pilot studies, supports the idea that this region's high rate of esophageal cancer may be related to long-term, high-level exposure to PAHs via inhalation of air-borne pollution and ingestion of food cooked with soft coal.
Thus, to assess the association of PAHs with the high rate of esophageal cancer in Linxian, China, we plan to analyze samples of food for the presence of PAHs, samples of blood for Hb adducts (a marker of long-term PAH exposure), samples of urine for 1-OH-Pyrene glucuronide (a maker of short-term PAH exposure), and samples of coal for characteristics that may be associated with increased carcinogenesis. We will also administer environmental questionnaires that will include questions about the type of fuel used for cooking and heating, the location and type of stove and/or heating unit (i.e., vented versus unvented), and time spent cooking.
Read the detailed description
The overall goal of this project is to determine whether polycyclic aromatic hydrocarbons (P AHs) or acetaldehyde are contributing to the high rate of esophageal cancer in Linxian, China.
Esophageal cancer is one of the most fatal cancers worldwide and Linxian, China has some of the highest rates of this cancer in the world. In the United States esophageal cancer causes approximately 14,000 deaths each year. It is the fourth most common cause of cancer death in black males and the eighth leading cause of cancer death in men of all races. The prevention and treatment of esophageal cancer within high risk groups continues to be limited by our inability to identify specific etiologic agents.
Human exposure to PAHs, including benzo[a]pyrene (B [a]P) is associated with increased rates of skin, lung, esophageal and gastric tumors and also with an increased mortality from causes related to atherosclerosis. Preliminary results from histologic and food analysis pilot studies supports the possibility that the high rates of esophageal cancer in Linxian may be related to long-term, high level exposure to PAHs via inhalation of air-borne pollution and ingestion of food cooked with soft coal.
Exposure to acetaldehyde could also be an etiologically significant exposure in Linxian. Acetaldehyde is a carcinogenic metabolite, and small quantities of ethanol where recently found in homogenized Linxian food samples. The Salaspuro laboratory at the University of Helsinki has demonstrated that oral bacteria can produce acetaldehyde from food containing similar small concentrations of ethanol, so such acetaldehyde exposure could be etiologically significant in Linxian. Genetic polymorphisms, particularly those involving alcohol and acetaldehyde dehydrogenases, may also influence the effect of this exposure.
To assess the association of PAHs and acetaldehyde with the high rate of esophageal cancer in Linxian, China, we plant o analyze samples of food for the presence of PAHs, ethanol and acetaldehyde, samples of blood for Hb and DNA adducts( markers of long-term PAH or acetaldehyde exposure), samples of urine for 1-OH-Pyrene glucuronide (a marker of short term PAH exposure) samples of saliva for acetaldehyde and samples of coal for characteristics that may be associated with increased carcinogenesis. We will also administer environmental questionnaires that will include questions about the type of fuel used for cooking and heating, the location and types of stove and/or heating units, and the time spent cooking.
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Polycyclic Aromatic Hydrocarbons
- 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 |
|---|---|---|
| 1 | Two of the oldest individuals (a male and a female greater than 18 years of age) from each of 10-15 nonsmoking households from the high-risk region of Linxian, China |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAH exposure
To assess the association of PAHs and acetaldehyde with the high rate of esophageal cancer in Linxian, China, we plant to analyze samples of food for the presence of PAHs, ethanol and acetaldehyde,samples of blood for Hb and DNA adducts( markers of longterm PAH or acetaldehyde exposure), samples of urine for 1-OH-Pyrene glucuronide (a marker of short term PAH exposure) samples of salivafor acetaldehyde and samples of coal for characteristics that may be associated with increased carcinogenesis. We will also administer environmental questionnaires that will include questions about the type of fuel used for cooking and heating, the location and types of stove and /or heating units, and the time spent cooking.
Measured: single time point, when samples are collected
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 start12 Feb 1998
- Primary completion1 Jan 2020
- Study completion5 Jun 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sanford M Dawsey, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342472
- Sponsor's protocol ID
- 999998008
- Other IDs
- OH98-C-N008
- Status last verified
- Dec 2020
- First submitted
- 19 Jun 2006
- Last updated
- 11 Dec 2020
- Results posted
- No
Publications
Li JY. Epidemiology of esophageal cancer in China. Natl Cancer Inst Monogr. 1982;62:113-20.
PubMed 7167171Ronneberg A, Andersen A. Mortality and cancer morbidity in workers from an aluminium smelter with prebaked carbon anodes--Part II: Cancer morbidity. Occup Environ Med. 1995 Apr;52(4):250-4. doi: 10.1136/oem.52.4.250.
PubMed 7795740Mumford JL, He XZ, Chapman RS, Cao SR, Harris DB, Li XM, Xian YL, Jiang WZ, Xu CW, Chuang JC, et al. Lung cancer and indoor air pollution in Xuan Wei, China. Science. 1987 Jan 9;235(4785):217-20. doi: 10.1126/science.3798109.
PubMed 3798109
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
- Environmental and Biological Monitoring Pilot Study for Polycyclic Aromatic Hydrocarbons in Linxian, China
- ClinicalTrials.gov ID
- NCT00342472
- Acronym / sponsor ID
- 999998008
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Polycyclic Aromatic Hydrocarbons
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 12 Feb 1998 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 5 Jun 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.
The overall goal of this project is to determine whether polycyclic aromatic hydrocarbons (PAHs) are contributing to the high rate of esophageal cancer in Linxian, China.
Esophageal cancer is one of the most fatal cancers worldwide with Linxian, China having one of the highest rates in the world. In the United States esophageal cancer causes approximately 10,000 deaths each year. It is the fourth most common cause of cancer death in black males and the eighth leading cause of cancer death in men of all races. Although several recent studies have identified some of the molecular changes associated with esophageal cancer, its prevention and treatment within high risk groups continues to be limited by our inability to identify specific etiologic agents.
Human exposure to PAHs, including benzo [a]pyrene (B[a]P), is associated with an increased rate of skin, lung, and upper GI tumors and also with an increased mortality from causes related to atherosclerosis. Evidence, including the preliminary results from histologic and food analysis pilot studies, supports the idea that this region's high rate of esophageal cancer may be related to long-term, high-level exposure to PAHs via inhalation of air-borne pollution and ingestion of food cooked with soft coal.
Thus, to assess the association of PAHs with the high rate of esophageal cancer in Linxian, China, we plan to analyze samples of food for the presence of PAHs, samples of blood for Hb adducts (a marker of long-term PAH exposure), samples of urine for 1-OH-Pyrene glucuronide (a maker of short-term PAH exposure), and samples of coal for characteristics that may be associated with increased carcinogenesis. We will also administer environmental questionnaires that will include questions about the type of fuel used for cooking and heating, the location and type of stove and/or heating unit (i.e., vented versus unvented), and time spent cooking.
Detailed description
The overall goal of this project is to determine whether polycyclic aromatic hydrocarbons (P AHs) or acetaldehyde are contributing to the high rate of esophageal cancer in Linxian, China.
Esophageal cancer is one of the most fatal cancers worldwide and Linxian, China has some of the highest rates of this cancer in the world. In the United States esophageal cancer causes approximately 14,000 deaths each year. It is the fourth most common cause of cancer death in black males and the eighth leading cause of cancer death in men of all races. The prevention and treatment of esophageal cancer within high risk groups continues to be limited by our inability to identify specific etiologic agents.
Human exposure to PAHs, including benzo[a]pyrene (B [a]P) is associated with increased rates of skin, lung, esophageal and gastric tumors and also with an increased mortality from causes related to atherosclerosis. Preliminary results from histologic and food analysis pilot studies supports the possibility that the high rates of esophageal cancer in Linxian may be related to long-term, high level exposure to PAHs via inhalation of air-borne pollution and ingestion of food cooked with soft coal.
Exposure to acetaldehyde could also be an etiologically significant exposure in Linxian. Acetaldehyde is a carcinogenic metabolite, and small quantities of ethanol where recently found in homogenized Linxian food samples. The Salaspuro laboratory at the University of Helsinki has demonstrated that oral bacteria can produce acetaldehyde from food containing similar small concentrations of ethanol, so such acetaldehyde exposure could be etiologically significant in Linxian. Genetic polymorphisms, particularly those involving alcohol and acetaldehyde dehydrogenases, may also influence the effect of this exposure.
To assess the association of PAHs and acetaldehyde with the high rate of esophageal cancer in Linxian, China, we plant o analyze samples of food for the presence of PAHs, ethanol and acetaldehyde, samples of blood for Hb and DNA adducts( markers of long-term PAH or acetaldehyde exposure), samples of urine for 1-OH-Pyrene glucuronide (a marker of short term PAH exposure) samples of saliva for acetaldehyde and samples of coal for characteristics that may be associated with increased carcinogenesis. We will also administer environmental questionnaires that will include questions about the type of fuel used for cooking and heating, the location and types of stove and/or heating units, and the time spent cooking.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Two of the oldest individuals (a male and a female greater than 18 years of age) from each of 10-15 nonsmoking households from the high-risk region of Linxian, China |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two of the oldest individuals (a male and a female greater than 18 years of age) from each of 10-15 nonsmoking households from the high-risk region of Linxian, China and, to the extent that is possible, from appropriately age matched controls from a total of 20 nonsmoking individuals from the low-risk region of Gejiu, Yunnan province will be selected to participate.
Key inclusion criteria (1 listed)
- Two of the oldest individuals (a male and a female greater than 18 years of age) from each of 10-15 nonsmoking households from the high-risk region of Linxian, China and, to the extent that is possible, from appropriately age matched controls from a total of 20 nonsmoking individuals from the low-risk region of Gejiu, Yunnan province will be selected to participate.
Key exclusion criteria (0 listed)
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
PAH exposure
Time frame: single time point, when samples are collected
To assess the association of PAHs and acetaldehyde with the high rate of esophageal cancer in Linxian, China, we plant to analyze samples of food for the presence of PAHs, ethanol and acetaldehyde,samples of blood for Hb and DNA adducts( markers of longterm PAH or acetaldehyde exposure), samples of urine for 1-OH-Pyrene glucuronide (a marker of short term PAH exposure) samples of salivafor acetaldehyde and samples of coal for characteristics that may be associated with increased carcinogenesis. We will also administer environmental questionnaires that will include questions about the type of fuel used for cooking and heating, the location and types of stove and /or heating units, and the time spent cooking.
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 7167171Li JY. Epidemiology of esophageal cancer in China. Natl Cancer Inst Monogr. 1982;62:113-20.
- Background: PubMed 7795740Ronneberg A, Andersen A. Mortality and cancer morbidity in workers from an aluminium smelter with prebaked carbon anodes--Part II: Cancer morbidity. Occup Environ Med. 1995 Apr;52(4):250-4. doi: 10.1136/oem.52.4.250.
- Background: PubMed 3798109Mumford JL, He XZ, Chapman RS, Cao SR, Harris DB, Li XM, Xian YL, Jiang WZ, Xu CW, Chuang JC, et al. Lung cancer and indoor air pollution in Xuan Wei, China. Science. 1987 Jan 9;235(4785):217-20. doi: 10.1126/science.3798109.
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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.
Sanford M Dawsey, M.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 China.
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 1 inclusion and 0 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 China. 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?
PAH exposure (time frame: single time point, when samples are collected). 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 NCT00342472, 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.