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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01016-35 | Other Identifier | ANSM |
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lack of enrollment
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Cancer surveillance has a significant cost and generate anxiety for the patient.
It is important to avoid exams that will not modify health support or whose results wont allow to decide.
Cancer surveillance has a significant cost and generate anxiety for the patient.
It is important to avoid exams that will not modify health support or whose results wont allow to decide.
Our study will help rationalise surveillance of soft tissue sarcoma and standardize medical practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chest radiography | Active Comparator | clinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year |
|
| chest CT | Active Comparator | clinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chest radiography | Procedure | surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients having an isolated and operable pulmonary relapse | % of patients having resectable or resected lung metastasis after 2 years of surveillance | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate quality of life | questionnaire STAI | every 3 months for 2 years then every 6 months for the 3rd year |
| evaluate free disease survival | Time between date of inclusion and date of clinical or radiological progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas PENEL, MD | Oscar Lambret Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Dijon | 21079 | France | |||
| Oscar Lambret Center |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| chest CT | Procedure | surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years |
|
| 5 years |
| evaluate overall survival | time between date of inclusion and date of death (whatever the cause is) | 5 years |
| evaluate irradiation received | measure of PDL (product dose length) for chest CT measure of PDS (product dose surface) for chest radiograph | 2 years |
| estimate false positive rate | patients operated for non metastatic lesions patients monitored for non metastatic nodules | 2 years |
| evaluate global health | using scale of pain EVA | every 3 months for 2 years then every 6 months for the 3rd year |
| medico economic evaluation | sum of direct and indirect costs | 5 years |
| Lille |
| 59020 |
| France |
| Léon BERARD Center | Lyon | 69008 | France |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |