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Status unknownNCT00598845MoMaTECUpdated Dec 23, 2014

Molecular Markers in Treatment in Endometrial Cancer

An observational study in Endometrial Neoplasms and Neoplasm Metastasis, sponsored by University of Bergen. Status unknown at 9 sites in 3 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2014-12-23.

Sponsored by University of Bergen · Observational

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
Female
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Study summary

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.

Read the detailed description

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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Conditions studied

  • Endometrial Neoplasms
  • Neoplasm Metastasis

Keywords

  • Endometrial cancer
  • Molecular markers
  • Lymph node metastasis
  • Prospective study
  • Prognosis
  • Cancer of Endometrium
  • Tumor Markers, Biological
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Bergen is the lead sponsor of 141 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with endometrial carcinoma that undergo an endometrial biopsy before treatment with hysterectomy with bilateral salpingoophorectomy with or without pelvic lymph node staging.

Inclusion criteria

  • Women with endometrial carcinoma
  • Available endometrial biopsy
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • No informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Consecutive numbers

    Patients with endometrial cancer

    Procedure: Tumor biopsy study

Interventions

  • ProcedureTumor biopsy study

    Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated.

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What researchers measure

Primary outcomes

  1. Presence of lymph node metastases

    Time frame: At primary treatment

Secondary outcomes

  1. Recurrent disease, death from disease

    Time frame: 5 years after primary treatment

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Study locations

9 of 9 sites recruiting
  • Gynecological Oncology, UZ Gasthuisberg
    Leuven, 3000, Belgium
    Recruiting
  • Sentralsykehuset i Førde
    Førde, N6807, Norway
    Recruiting
  • Helse-Fonna, Haugesund Sjukehus
    Haugesund, N5528, Norway
    Recruiting
  • Kvinneklinikken, Akershus Universitetssykehus
    Lørenskog, N1478, Norway
    Recruiting
  • Kvinnesenteret, Ullevål Universitetssykehus
    Oslo, N0450, Norway
    Recruiting
  • Department of Gynecology, St Olav's Hospital
    Trondheim, N7006, Norway
    Recruiting
  • Sykehuset Vestfold HF
    Tønsberg, N3103, Norway
    Recruiting
  • Department of Gynecology, Ålesund Hospital
    Ålesund, Norway
    • Margareth S. Lode, MD · Contact
    Recruiting
  • Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital
    Gothenburg, SE-41345, Sweden
    Recruiting
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References and documents

Publications

  • 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. PubMed 16677592 ↗
  • 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. PubMed 16540684 ↗
  • 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. PubMed 16330673 ↗
  • 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. PubMed 15051772 ↗
  • 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. PubMed 12460889 ↗
  • 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. PubMed 10334522 ↗
  • 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. PubMed 19800606 ↗
  • 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. PubMed 19261849 ↗
  • 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. PubMed 18552176 ↗
  • 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. PubMed 23932335 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00598845
Lead sponsor
University of Bergen
Collaborators
Helse-Bergen HF, Norwegian Cancer Society
Responsible party
Helga B Salvesen (Professor, MD, PhD, University of Bergen) — Principal investigator
First posted
Jan 23, 2008
Start date
Apr 2001
Primary completion
Dec 2015 (estimated)
Completion
Dec 2017 (estimated)
Last update
Dec 23, 2014

Study contacts

Britt Edvardsen, AVD ING
Contact
britt.edvardsen@helse-bergen.no
+4755974200 ext. 6336
Ingjerd Bergo, Tech
Contact
ingjerd.bergo@helse-bergen.no
+4755974200
Helga B. Salvesen, Prof., MD, PhD
principal investigator · University of Bergen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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