Esophageal Squamous Cell CarcinomaNCT03206125
NCI UNC Project ESCC
An observational study of Esophageal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 2 sites in Malawi.
Trial summary
Background: Esophageal cancer is a common cause of cancer deaths. Most cases of this cancer are esophageal squamous cell carcinoma (ESCC). Many of these cases come from two parts of the world with high-risk. One of these is in East Africa and include the country of Malawi. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 648 participants
- Where
- 2 sitesMalawi
- Study dates
- 1 Aug 2017to 15 May 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 300 ESCC cases and 300 controls recruited from Kamuzu Central Hospital and St Gabriel s Hospital, Namitete (FWA: 00018517) which is 50 km from Kamuzu Central Hospital located in Lilongwe, Malawi.
Who may be able to join
- All suspected ESCC cases will be eligible for enrollment.
- All KCH and St Gabriel s patients greater than or eqaul to 18 years of age who are residents of the Central Region of Malawi and are diagnosed with histology-confirmed ESCC will be invited to participate as cases in the study.
Who cannot join
- Patients <18 years old
- Those living outside the Central Region, those who are medically unable to complete the study procedures (including questionnaire, biosample collection or endoscopy), and those who are unable to understand the study procedures or give informed consent.
- While we do expect to see younger people with ESCC in Malawi (as we have seen in Kenya), cases under the age of 18 are rare: the field team would expect to see one or two a year. This estimate is in line with the cancer registry data from Malawi. Therefore, we will not enroll subjects younger than 18 years old.
Trial locations and contacts
2 sites in 1 country.
Malawi2 sites
Kazumu Central Hospital (KCH)
Lilongwe
St Gabriel's Hospital
Namitete
About this study
Official title: A Case-Control Study of Esophageal Squamous Cell Carcinoma in Lilongwe, Malawi
Background:
Esophageal cancer is a common cause of cancer deaths. Most cases of this cancer are esophageal squamous cell carcinoma (ESCC). Many of these cases come from two parts of the world with high-risk. One of these is in East Africa and include the country of Malawi. Researchers want to learn what factors explain the high risk there so we can understand better what causes this cancer in people everywhere.
Read more
Objective:
To learn more about causes and outcomes of esophageal squamous cell carcinoma using Malawi because of the large number of cases in that country.
Eligibility:
Adults at least 18 years old who have ESCC and live in a certain region of Malawi
Adults in the same age group and location who do not have ESCC
Design:
Participants will be screened at a hospital in Malawi.
Participants will have a 1-hour interview. They will answer questions about:
Demographics (age, ethnicity, education)
Place of residence
Medical history and family medical history
Drug, alcohol, and tobacco use
Hot beverage consumption
Indoor air pollution
Occupation
Food habits
Farming
Gastrointestinal health
Participants will have their teeth and fingernails examined.
Participants will be asked to give samples of blood, urine, saliva, toenails, and for the cancer cases, a small piece of their tumor.
Participants will have 4 phone calls a year for 2 years to ask about their health....
Read the detailed description
Background: Esophageal cancer causes an estimated 400,000 deaths per year and ranks as the sixth leading cause of cancer death worldwide, just after breast cancer. Esophageal squamous cell carcinoma (ESCC) accounts for 89% of all esophageal cancer cases worldwide and many of the cases originate in two high risk regions, one in Asia and the other in Africa.
Smoking tobacco and heavy alcohol consumption do not explain the incidence rates in the high-risk regions. It is therefore important to consider a wide range of etiologic factors to explain the high rates of cancer in these populations.
Malawi has the highest incidence rates of ESCC in Africa. Our previous studies in Kenya and preliminary studies in Malawi point to a number of potential ESCC risk factors.
Objectives: Our study aims to enhance our understanding of the causes and outcomes for ESCC in Malawi
Eligibility: All suspected ESCC cases will be eligible for enrollment.
Design: We will conduct a case-control study of ESCC jointly at Kamuzu Central Hospital and St. Gabriel s Hospital, recruiting 300 ESCC cases and 300 controls, to (1) evaluate exposures (including consumption of very hot beverages, use of firewood as fuel, tooth loss and animal exposure) which may influence risk of ESCC in Malawi and (2) collect biological samples to quantify exposures of interest (included in the current proposal) and to study the genetics and genomics of ESCC tumors (to be included in a future proposal).
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Squamous Cell Carcinoma, Case-Control Study, Risk Factors, Epidemiology
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
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 |
|---|---|---|
| Controls | Controls | |
| ESCC Cases | ESCC Cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal squamous cell carcinoma
Pathology confirmed from endoscopic biopsy
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 posted2 Jul 2017
- Study start1 Aug 2017
- Primary completion15 May 2020
- Study completion15 May 2020
Why it stopped: determined not to be human subjects research
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 Squamous Cell CarcinomaStudies 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
- Other
- Enrolment
- 648 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
- NCT03206125
- Sponsor's protocol ID
- 999917120
- Other IDs
- 17-C-N120
- Status last verified
- May 2020
- First submitted
- 30 Jun 2017
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
White RE, Parker RK, Fitzwater JW, Kasepoi Z, Topazian M. Stents as sole therapy for oesophageal cancer: a prospective analysis of outcomes after placement. Lancet Oncol. 2009 Mar;10(3):240-6. doi: 10.1016/S1470-2045(09)70004-X. Epub 2009 Feb 18.
PubMed 19230771Liu W, Snell JM, Jeck WR, Hoadley KA, Wilkerson MD, Parker JS, Patel N, Mlombe YB, Mulima G, Liomba NG, Wolf LL, Shores CG, Gopal S, Sharpless NE. Subtyping sub-Saharan esophageal squamous cell carcinoma by comprehensive molecular analysis. JCI Insight. 2016 Oct 6;1(16):e88755. doi: 10.1172/jci.insight.88755.
PubMed 27734031Mlombe YB, Rosenberg NE, Wolf LL, Dzamalala CP, Chalulu K, Chisi J, Shaheen NJ, Hosseinipour MC, Shores CG. Environmental risk factors for oesophageal cancer in Malawi: A case-control study. Malawi Med J. 2015 Sep;27(3):88-92. doi: 10.4314/mmj.v27i3.3.
PubMed 26715952
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control Study of Esophageal Squamous Cell Carcinoma in Lilongwe, Malawi
- ClinicalTrials.gov ID
- NCT03206125
- Acronym / sponsor ID
- 999917120
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Squamous Cell Carcinoma, Case-Control Study, Risk Factors, Epidemiology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: determined not to be human subjects research
- Enrolment
- 648 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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.
Background:
Esophageal cancer is a common cause of cancer deaths. Most cases of this cancer are esophageal squamous cell carcinoma (ESCC). Many of these cases come from two parts of the world with high-risk. One of these is in East Africa and include the country of Malawi. Researchers want to learn what factors explain the high risk there so we can understand better what causes this cancer in people everywhere.
Objective:
To learn more about causes and outcomes of esophageal squamous cell carcinoma using Malawi because of the large number of cases in that country.
Eligibility:
Adults at least 18 years old who have ESCC and live in a certain region of Malawi
Adults in the same age group and location who do not have ESCC
Design:
Participants will be screened at a hospital in Malawi.
Participants will have a 1-hour interview. They will answer questions about:
Demographics (age, ethnicity, education)
Place of residence
Medical history and family medical history
Drug, alcohol, and tobacco use
Hot beverage consumption
Indoor air pollution
Occupation
Food habits
Farming
Gastrointestinal health
Participants will have their teeth and fingernails examined.
Participants will be asked to give samples of blood, urine, saliva, toenails, and for the cancer cases, a small piece of their tumor.
Participants will have 4 phone calls a year for 2 years to ask about their health....
Detailed description
Background: Esophageal cancer causes an estimated 400,000 deaths per year and ranks as the sixth leading cause of cancer death worldwide, just after breast cancer. Esophageal squamous cell carcinoma (ESCC) accounts for 89% of all esophageal cancer cases worldwide and many of the cases originate in two high risk regions, one in Asia and the other in Africa.
Smoking tobacco and heavy alcohol consumption do not explain the incidence rates in the high-risk regions. It is therefore important to consider a wide range of etiologic factors to explain the high rates of cancer in these populations.
Malawi has the highest incidence rates of ESCC in Africa. Our previous studies in Kenya and preliminary studies in Malawi point to a number of potential ESCC risk factors.
Objectives: Our study aims to enhance our understanding of the causes and outcomes for ESCC in Malawi
Eligibility: All suspected ESCC cases will be eligible for enrollment.
Design: We will conduct a case-control study of ESCC jointly at Kamuzu Central Hospital and St. Gabriel s Hospital, recruiting 300 ESCC cases and 300 controls, to (1) evaluate exposures (including consumption of very hot beverages, use of firewood as fuel, tooth loss and animal exposure) which may influence risk of ESCC in Malawi and (2) collect biological samples to quantify exposures of interest (included in the current proposal) and to study the genetics and genomics of ESCC tumors (to be included in a future proposal).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Controls |
| ESCC Cases | – | –ESCC Cases |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 300 ESCC cases and 300 controls recruited from Kamuzu Central Hospital and St Gabriel s Hospital, Namitete (FWA: 00018517) which is 50 km from Kamuzu Central Hospital located in Lilongwe, Malawi.
Key inclusion criteria (2 listed)
- All suspected ESCC cases will be eligible for enrollment.
- All KCH and St Gabriel s patients greater than or eqaul to 18 years of age who are residents of the Central Region of Malawi and are diagnosed with histology-confirmed ESCC will be invited to participate as cases in the study.
Key exclusion criteria (3 listed)
- Patients <18 years old
- Those living outside the Central Region, those who are medically unable to complete the study procedures (including questionnaire, biosample collection or endoscopy), and those who are unable to understand the study procedures or give informed consent.
- While we do expect to see younger people with ESCC in Malawi (as we have seen in Kenya), cases under the age of 18 are rare: the field team would expect to see one or two a year. This estimate is in line with the cancer registry data from Malawi. Therefore, we will not enroll subjects younger than 18 years old.
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 squamous cell carcinoma
Time frame: At diagnosis
Pathology confirmed from endoscopic biopsy
Results and safety
The study was stopped early (reason given: determined not to be human subjects research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Background: PubMed 19230771White RE, Parker RK, Fitzwater JW, Kasepoi Z, Topazian M. Stents as sole therapy for oesophageal cancer: a prospective analysis of outcomes after placement. Lancet Oncol. 2009 Mar;10(3):240-6. doi: 10.1016/S1470-2045(09)70004-X. Epub 2009 Feb 18.
- Background: PubMed 27734031Liu W, Snell JM, Jeck WR, Hoadley KA, Wilkerson MD, Parker JS, Patel N, Mlombe YB, Mulima G, Liomba NG, Wolf LL, Shores CG, Gopal S, Sharpless NE. Subtyping sub-Saharan esophageal squamous cell carcinoma by comprehensive molecular analysis. JCI Insight. 2016 Oct 6;1(16):e88755. doi: 10.1172/jci.insight.88755.
- Background: PubMed 26715952Mlombe YB, Rosenberg NE, Wolf LL, Dzamalala CP, Chalulu K, Chisi J, Shaheen NJ, Hosseinipour MC, Shores CG. Environmental risk factors for oesophageal cancer in Malawi: A case-control study. Malawi Med J. 2015 Sep;27(3):88-92. doi: 10.4314/mmj.v27i3.3.
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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)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 2 sites in Malawi.
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 2 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: stopped early, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi. 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 was stopped early (reason given: determined not to be human subjects research). Results are not available in the source record.
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 squamous cell carcinoma (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 NCT03206125, 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 20 May 2020.