Soft Tissue SarcomaNCT02080897
Evaluating Quality of Life in Patients With Soft Tissue Sarcoma Presenting With Metastatic Lung Disease
An observational study of Soft Tissue Sarcoma and Metastatic Lung Disease, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the role of palliative surgery in improving Quality of Life (QoL) and symptom control for patients who present with a Soft Tissue Sarcoma (STS) and metastatic lung disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma, Metastatic Lung Disease
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 7 Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with soft tissue sarcoma with metastatic lung disease
Who may be able to join
- Patients with soft tissue sarcoma with at least one pulmonary metastasis
- Metastatic lung disease must have been present at time of initial presentation
Who cannot join
- All patients under 18 will be excluded
- Patients who have been previously undergone surgical resection of the primary tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Evaluating Quality of Life in Patients With Soft Tissue Sarcoma Presenting With Metastatic Lung Disease Using the ESAS-Sarcoma Modified Questionnaire
The purpose of this study is to evaluate the role of palliative surgery in improving Quality of Life (QoL) and symptom control for patients who present with a Soft Tissue Sarcoma (STS) and metastatic lung disease. Responses to clinical Edmonton Symptom Assessment System - Sarcoma Modified ( ESAS-SM) questionnaire for patients who have undergone surgery for resection of the primary tumour will be compared to those that are unable to have surgery. Data collected from this questionnaire can highlight the benefits in patients' QoL who receive palliative surgical resection, and whether these benefits surmount those who are not treated with palliative surgery.
- Conditions
- Soft Tissue Sarcoma, Metastatic Lung Disease
- Keywords
- non-surgical, palliative surgery
- Medical subject headings
- Sarcoma, Lung Diseases
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 |
|---|---|---|
| Palliative Surgery Group | Patients who present to clinic with soft tissue sarcoma with metastatic lung disease who opt to proceed with palliative surgical treatment | |
| Non-surgical Group | Patients who present to clinic with soft tissue sarcoma with metastatic lung disease who opt not to pursue palliative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QoL score using patient-response questionnaire
The Edmonton Symptom Assessment System - Sarcoma Modified ( ESAS-SM) questionnaire will be completed at baseline, 6 weeks and 3, 6, 12, 24, 36 and 60 months post presentation/surgical intervention.
Measured: questionnaire will be obtained at initial presentation and at up to 7 additional visits (6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months after initial presentation or treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Eward, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080897
- Sponsor's protocol ID
- Pro00044852
- Status last verified
- Apr 2018
- First submitted
- 5 Mar 2014
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Quality of Life in Patients With Soft Tissue Sarcoma Presenting With Metastatic Lung Disease Using the ESAS-Sarcoma Modified Questionnaire
- ClinicalTrials.gov ID
- NCT02080897
- Acronym / sponsor ID
- Pro00044852
- Conditions
- Soft Tissue Sarcoma, Metastatic Lung Disease
- Keywords
- non-surgical, palliative surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 7 Mar 2014 (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 purpose of this study is to evaluate the role of palliative surgery in improving Quality of Life (QoL) and symptom control for patients who present with a Soft Tissue Sarcoma (STS) and metastatic lung disease. Responses to clinical Edmonton Symptom Assessment System - Sarcoma Modified ( ESAS-SM) questionnaire for patients who have undergone surgery for resection of the primary tumour will be compared to those that are unable to have surgery. Data collected from this questionnaire can highlight the benefits in patients' QoL who receive palliative surgical resection, and whether these benefits surmount those who are not treated with palliative surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palliative Surgery Group | – | –Patients who present to clinic with soft tissue sarcoma with metastatic lung disease who opt to proceed with palliative surgical treatment |
| Non-surgical Group | – | –Patients who present to clinic with soft tissue sarcoma with metastatic lung disease who opt not to pursue palliative surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with soft tissue sarcoma with metastatic lung disease
Key inclusion criteria (2 listed)
- Patients with soft tissue sarcoma with at least one pulmonary metastasis
- Metastatic lung disease must have been present at time of initial presentation
Key exclusion criteria (2 listed)
- All patients under 18 will be excluded
- Patients who have been previously undergone surgical resection of the primary tumor
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
Change in QoL score using patient-response questionnaire
Time frame: questionnaire will be obtained at initial presentation and at up to 7 additional visits (6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months after initial presentation or treatment)
The Edmonton Symptom Assessment System - Sarcoma Modified ( ESAS-SM) questionnaire will be completed at baseline, 6 weeks and 3, 6, 12, 24, 36 and 60 months post presentation/surgical intervention.
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 10 Apr 2018.
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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.
William Eward, MD principal investigator
Duke University
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 Soft Tissue Sarcoma and Metastatic Lung Disease, run by Duke University 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 2 inclusion and 2 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 10 Apr 2018. 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?
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?
Change in QoL score using patient-response questionnaire (time frame: questionnaire will be obtained at initial presentation and at up to 7 additional visits (6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months after initial presentation or treatment)). 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 10 Apr 2018.