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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Danish Cancer Society | OTHER |
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The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High risk endometrial cancer | Other | Patients will receive sentinel node mapping, removal of PET-positive lymph nodes and finally conventional pelvic and paraaortic lymphadenectomy. |
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| Cervical cancer tumor size 2-4 cm | Other | Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLN mapping and removal of PET-positive lymph nodes | Procedure | Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes | 2 years |
| Negative predictive value | Negative predictive value of sentinel lymph node mapping algorithm, and a sentinel lymph node mapping algorithm including removal of PET-positive lymph nodes | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes | 2 years |
| Positive predictive value | Positive predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernille T Jensen, Professor | Aarhus University Hospital and Aarhus University, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark | |||
| Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33829991 | Derived | Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 4, 2020 | Sep 19, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Endometrial cancer, Diagnostic; Assessing the safety of the SLN mapping algorithm. Inclusion is defined by a power calculation: Assuming the true incidence of metastasis is 20% and the sensitivity of the SLN mapping algorithm is 96%. To obtain the conclusion that NPV is larger than 94% using a 95% two-sided exact Clopper-Pearson confidence interval, then 150 women with sentinel lymph node mapping, a FDG/PET-CT and Pelvic- and paraaortic lymph node dissection are needed.
Cervical cancer: Study is diagnostic and primarily explorative.
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| 2 years |
| Prevalence of lymph node metastasis | Prevalence of lymph node metastasis in the pelvis and paraaortic area | 2 years |
| Incidence of lymphedema | Using patient reported outcome measures | 3 years |
| Severity of lymphedema | Using patient reported outcome measures | 3 years |
| Quality of life rate | Using patient reported outcome measures | 3 years |
| Copenhagen |
| 2100 |
| Denmark |
| Herlev Hospital | Herlev | 2730 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| D002577 |
| Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |