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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02080897
Other study ID # Pro00044852
Secondary ID
Status Completed
Phase
First received March 5, 2014
Last updated April 9, 2018
Start date March 2014
Est. completion date August 7, 2017

Study information

Verified date April 2018
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date August 7, 2017
Est. primary completion date August 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with soft tissue sarcoma with at least one pulmonary metastasis

- Metastatic lung disease must have been present at time of initial presentation

Exclusion Criteria:

- All patients under 18 will be excluded

- Patients who have been previously undergone surgical resection of the primary tumor

Study Design


Locations

Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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)
See also
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