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| ID | Type | Description | Link |
|---|---|---|---|
| NSD 15501 | |||
| REK 96/1478-2 | |||
| Helse Vest 911351 |
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| Name | Class |
|---|---|
| Helse-Bergen HF | OTHER |
| Norwegian Cancer Society | OTHER |
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The purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment.
This is a prospective multicenter study to investigate the predictive value of molecular markers in endometrial cancer for lymph node metastasis, prognosis and treatment. For the previously studied tumor markers p53, p16, ER, PR and HER2neu, we want to investigate the expression in curettage material in relation to lymph node metastasis and prognosis among endometrial carcinoma patients. We also want to investigate the distribution of genetic alterations in fresh frozen tumor tissue in order to design prospective randomized treatment trials of metastatic endometrial cancer based on molecular profile. There will be a special emphasis on disturbances in the pathways influenced by new targeted therapy, such as inhibitors of Her2/NEU, EGFR, receptor tyrosine kinase, mTOR, PTEN and hormone receptor pathways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consecutive numbers | Patients with endometrial cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor biopsy study | Procedure | Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of lymph node metastases | At primary treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent disease, death from disease | 5 years after primary treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Women with endometrial carcinoma that undergo an endometrial biopsy before treatment with hysterectomy with bilateral salpingoophorectomy with or without pelvic lymph node staging.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Britt Edvardsen, AVD ING | Contact | +4755974200 | 6336 | britt.edvardsen@helse-bergen.no |
| Ingjerd Bergo, Tech | Contact | +4755974200 | ingjerd.bergo@helse-bergen.no |
| Name | Affiliation | Role |
|---|---|---|
| Helga B. Salvesen, Prof., MD, PhD | University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynecological Oncology, UZ Gasthuisberg | Recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16677592 | Background | Engelsen IB, Stefansson I, Akslen LA, Salvesen HB. Pathologic expression of p53 or p16 in preoperative curettage specimens identifies high-risk endometrial carcinomas. Am J Obstet Gynecol. 2006 Oct;195(4):979-86. doi: 10.1016/j.ajog.2006.02.045. Epub 2006 May 3. | |
| 16540684 | Background | Stefansson IM, Salvesen HB, Akslen LA. Vascular proliferation is important for clinical progress of endometrial cancer. Cancer Res. 2006 Mar 15;66(6):3303-9. doi: 10.1158/0008-5472.CAN-05-1163. |
| Label | URL |
|---|---|
| Nordic Society of Gynecologic Oncology | View source |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009362 | Neoplasm Metastasis |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Tumor specimens from endometrial carcinoma, from curettage and hysterectomy specimens, formalin-fixed and paraffin-embedded and fresh frozen, stored at minus 80 °C, corresponding blood samples with normal DNA
| Department of Gynecology, Ålesund Hospital | Recruiting | Ålesund | Norway |
|
| Sentralsykehuset i Førde | Recruiting | Førde | N6807 | Norway |
|
| Helse-Fonna, Haugesund Sjukehus | Recruiting | Haugesund | N5528 | Norway |
|
| Kvinneklinikken, Akershus Universitetssykehus | Recruiting | Lørenskog | N1478 | Norway |
|
| Kvinnesenteret, Ullevål Universitetssykehus | Recruiting | Oslo | N0450 | Norway |
|
| Department of Gynecology, St Olav's Hospital | Recruiting | Trondheim | N7006 | Norway |
|
| Sykehuset Vestfold HF | Recruiting | Tønsberg | N3103 | Norway |
|
| Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital | Recruiting | Gothenburg | SE-41345 | Sweden |
|
| 16330673 | Background | Bachmann IM, Halvorsen OJ, Collett K, Stefansson IM, Straume O, Haukaas SA, Salvesen HB, Otte AP, Akslen LA. EZH2 expression is associated with high proliferation rate and aggressive tumor subgroups in cutaneous melanoma and cancers of the endometrium, prostate, and breast. J Clin Oncol. 2006 Jan 10;24(2):268-73. doi: 10.1200/JCO.2005.01.5180. Epub 2005 Dec 5. |
| 15051772 | Background | Stefansson IM, Salvesen HB, Akslen LA. Prognostic impact of alterations in P-cadherin expression and related cell adhesion markers in endometrial cancer. J Clin Oncol. 2004 Apr 1;22(7):1242-52. doi: 10.1200/JCO.2004.09.034. |
| 12460889 | Background | Straume O, Chappuis PO, Salvesen HB, Halvorsen OJ, Haukaas SA, Goffin JR, Begin LR, Foulkes WD, Akslen LA. Prognostic importance of glomeruloid microvascular proliferation indicates an aggressive angiogenic phenotype in human cancers. Cancer Res. 2002 Dec 1;62(23):6808-11. |
| 10334522 | Background | Salvesen HB, Iversen OE, Akslen LA. Prognostic significance of angiogenesis and Ki-67, p53, and p21 expression: a population-based endometrial carcinoma study. J Clin Oncol. 1999 May;17(5):1382-90. doi: 10.1200/JCO.1999.17.5.1382. |
| 19800606 | Background | Wik E, Trovik J, Iversen OE, Engelsen IB, Stefansson IM, Vestrheim LC, Haugland HK, Akslen LA, Salvesen HB. Deoxyribonucleic acid ploidy in endometrial carcinoma: a reproducible and valid prognostic marker in a routine diagnostic setting. Am J Obstet Gynecol. 2009 Dec;201(6):603.e1-7. doi: 10.1016/j.ajog.2009.07.029. Epub 2009 Oct 3. |
| 19261849 | Background | Salvesen HB, Carter SL, Mannelqvist M, Dutt A, Getz G, Stefansson IM, Raeder MB, Sos ML, Engelsen IB, Trovik J, Wik E, Greulich H, Bo TH, Jonassen I, Thomas RK, Zander T, Garraway LA, Oyan AM, Sellers WR, Kalland KH, Meyerson M, Akslen LA, Beroukhim R. Integrated genomic profiling of endometrial carcinoma associates aggressive tumors with indicators of PI3 kinase activation. Proc Natl Acad Sci U S A. 2009 Mar 24;106(12):4834-9. doi: 10.1073/pnas.0806514106. Epub 2009 Mar 4. |
| 18552176 | Background | Dutt A, Salvesen HB, Chen TH, Ramos AH, Onofrio RC, Hatton C, Nicoletti R, Winckler W, Grewal R, Hanna M, Wyhs N, Ziaugra L, Richter DJ, Trovik J, Engelsen IB, Stefansson IM, Fennell T, Cibulskis K, Zody MC, Akslen LA, Gabriel S, Wong KK, Sellers WR, Meyerson M, Greulich H. Drug-sensitive FGFR2 mutations in endometrial carcinoma. Proc Natl Acad Sci U S A. 2008 Jun 24;105(25):8713-7. doi: 10.1073/pnas.0803379105. Epub 2008 Jun 13. |
| 23932335 | Derived | Trovik J, Wik E, Werner HM, Krakstad C, Helland H, Vandenput I, Njolstad TS, Stefansson IM, Marcickiewicz J, Tingulstad S, Staff AC; MoMaTEC study group; Amant F, Akslen LA, Salvesen HB. Hormone receptor loss in endometrial carcinoma curettage predicts lymph node metastasis and poor outcome in prospective multicentre trial. Eur J Cancer. 2013 Nov;49(16):3431-41. doi: 10.1016/j.ejca.2013.06.016. Epub 2013 Aug 8. |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |