Esophageal NeoplasmsUDDNCT02530983
Mayo Clinic Upper Digestive Disease Survey
An observational study of Esophageal Neoplasms and Cancer of Esophagus, run by Mayo Clinic at 1 site in United States.
Trial summary
The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms, Cancer of Esophagus, Cancer of the Esophagus
- What is being tested?
- Mayo Clinic Upper Digestive Disease Survey on Paper and Upper Digestive Disease (UDD Monitor) App
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2015to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.
Who may be able to join
- Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Karlyn Pierson, MAN, RN, 507-538-1960, pierson.karlyn@mayo.edu
About this study
The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures. Data will be used to establish the validation of the questionnaires/survey. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure and for upper digestive diseases. Data will contribute to creating treatment algorithms for symptom management for upper digestive diseases and for post-operative complications and symptoms as well as contribute to pre-operative education.
Read the detailed description
The Mayo Clinic Conduit Report Card Questionnaires are a compilation of standard questionnaires and questions that have been created specifically for this study some of which are patient report and others that are administered by the provider or study staff. It includes the Promis Global Health Score, modified Mayo GER Score questions, modified Dysphagia Questionnaire-30 Day questions, and Zubrod Score. It also includes a 10-point scale to grade postoperative pain, milk assessment, Modified Mayo Reflux Score adapted from the Mayo Clinic Reflux Score, Dumping Score adapted from Sigstad's Scoring System, Simple Dysphagia Score adapted from Mellows and Pinkas, Stricture Score adapted from Blackmon, et al., Pyloric Spasm Score, and Conduit Emptying Score abstracted from Vaezi, Baker, Achkar, and Richter. We will also be collecting information on their demographics, operation, nutritional status, laboratory values, testing results and clinical outcomes.
Patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients who undergo surgery and at one month following diagnosis and then every three months for 1 year after diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients that do not undergo surgery. The questionnaire can be completed at their clinic visit, over the telephone, or by mail using the paper form or may be completed using an electronic application. The electronic version is available for Mayo Clinic and non Mayo Clinic patients through the app store in conjunction Mayo IT.
- Conditions
- Esophageal Neoplasms, Cancer of Esophagus, Cancer of the Esophagus, Esophageal Cancer, Esophagus Cancer, Neoplasm, Esophageal
- Being tested
- Mayo Clinic Upper Digestive Disease Survey on Paper, Upper Digestive Disease (UDD Monitor) App
- Medical subject headings
- Esophageal Neoplasms, Digestive System Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mayo Clinic Upper Digestive Disease Survey on PaperOther
Mayo Clinic patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information.
Upper Digestive Disease (UDD Monitor) AppOther
Mayo Clinic and non Mayo Clinic patients can participate by loading the app through the app store. Patient consent will be completed in the app. Patients will be asked to complete questionnaires at their 1.5 month surgical or diagnosis follow up and then every three months for 1 year after their surgery or diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime or as long as they want to participate.
for iOS: https://apps.apple.com/us/app/upper-digestive-disease/id6448756724 for Android: https://play.google.com/store/apps/details?id=com.mayoclinic.uddmobile\&pli=1
| Study group | Role | What they receive |
|---|---|---|
| Esophagectomy/Esophageal Reconstruction/Treatment | Patients who have undergone esophagectomy, esophageal reconstruction, or treatment Receives: Other: Mayo Clinic Upper Digestive Disease Survey on Paper; Other: Upper Digestive Disease (UDD Monitor) App | |
| Upper Digestive Disease | Patients who have an upper digestive disease. Receives: Other: Mayo Clinic Upper Digestive Disease Survey on Paper; Other: Upper Digestive Disease (UDD Monitor) App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the Mayo Clinic Upper Digestive Disease Survey by patients at varying time points following surgery
Completed Mayo Clinic Upper Digestive Disease Survey will be analyzed and used to establish validation.
Measured: 1 year
Secondary outcomes (1)
Establishment of "normal" or expected scores from the Mayo Clinic Upper Digestive Disease Survey
Completed Mayo Clinic Upper Digestive Disease Survey will be used in the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure at different time points following surgery.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study start15 Aug 2015
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis F. Tapias Vargas, Mayo Clinic
- Investigators
- Luis Tapias Vargas, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530983
- Sponsor's protocol ID
- 14-009873
- Acronym
- UDD
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2015
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mayo Clinic Upper Digestive Disease Survey
- ClinicalTrials.gov ID
- NCT02530983
- Acronym / sponsor ID
- UDD / 14-009873
- Conditions
- Esophageal Neoplasms, Cancer of Esophagus, Cancer of the Esophagus, Esophageal Cancer, Esophagus Cancer, Neoplasm, Esophageal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Aug 2015 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Aug 2015 (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 Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures. Data will be used to establish the validation of the questionnaires/survey. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure and for upper digestive diseases. Data will contribute to creating treatment algorithms for symptom management for upper digestive diseases and for post-operative complications and symptoms as well as contribute to pre-operative education.
Detailed description
The Mayo Clinic Conduit Report Card Questionnaires are a compilation of standard questionnaires and questions that have been created specifically for this study some of which are patient report and others that are administered by the provider or study staff. It includes the Promis Global Health Score, modified Mayo GER Score questions, modified Dysphagia Questionnaire-30 Day questions, and Zubrod Score. It also includes a 10-point scale to grade postoperative pain, milk assessment, Modified Mayo Reflux Score adapted from the Mayo Clinic Reflux Score, Dumping Score adapted from Sigstad's Scoring System, Simple Dysphagia Score adapted from Mellows and Pinkas, Stricture Score adapted from Blackmon, et al., Pyloric Spasm Score, and Conduit Emptying Score abstracted from Vaezi, Baker, Achkar, and Richter. We will also be collecting information on their demographics, operation, nutritional status, laboratory values, testing results and clinical outcomes.
Patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients who undergo surgery and at one month following diagnosis and then every three months for 1 year after diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients that do not undergo surgery. The questionnaire can be completed at their clinic visit, over the telephone, or by mail using the paper form or may be completed using an electronic application. The electronic version is available for Mayo Clinic and non Mayo Clinic patients through the app store in conjunction Mayo IT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esophagectomy/Esophageal Reconstruction/Treatment | – | Other: Mayo Clinic Upper Digestive Disease Survey on Paper, Other: Upper Digestive Disease (UDD Monitor) AppPatients who have undergone esophagectomy, esophageal reconstruction, or treatment |
| Upper Digestive Disease | – | Other: Mayo Clinic Upper Digestive Disease Survey on Paper, Other: Upper Digestive Disease (UDD Monitor) AppPatients who have an upper digestive disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.
Key inclusion criteria (1 listed)
- Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mayo Clinic Upper Digestive Disease Survey on PaperMayo Clinic patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information. | Other | Esophagectomy/Esophageal Reconstruction/Treatment, Upper Digestive Disease |
| Upper Digestive Disease (UDD Monitor) AppMayo Clinic and non Mayo Clinic patients can participate by loading the app through the app store. Patient consent will be completed in the app. Patients will be asked to complete questionnaires at their 1.5 month surgical or diagnosis follow up and then every three months for 1 year after their surgery or diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime or as long as they want to participate. for iOS: https://apps.apple.com/us/app/upper-digestive-disease/id6448756724 for Android: https://play.google.com/store/apps/details?id=com.mayoclinic.uddmobile\&pli=1 | Other | Esophagectomy/Esophageal Reconstruction/Treatment, Upper Digestive Disease |
Primary outcome
Completion of the Mayo Clinic Upper Digestive Disease Survey by patients at varying time points following surgery
Time frame: 1 year
Completed Mayo Clinic Upper Digestive Disease Survey will be analyzed and used to establish validation.
1 secondary outcome
Establishment of "normal" or expected scores from the Mayo Clinic Upper Digestive Disease Survey
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Luis Tapias Vargas, MD principal investigator
Mayo Clinic
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 Neoplasms and Cancer of Esophagus, run by Mayo Clinic at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamad Khair Abou Chaar, MD (507-422-9936, AbouChaar.MohamadKhairM@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of the Mayo Clinic Upper Digestive Disease Survey by patients at varying time points following surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.