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Endometrial NeoplasmsMoMaTECNCT00598845

Molecular Markers in Treatment in Endometrial Cancer

An observational study of Endometrial Neoplasms and Neoplasm Metastasis, run by University of Bergen at 9 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Any age, women only
Conditions the study is for
Endometrial Neoplasms, Neoplasm Metastasis
What is being tested?
Tumor biopsy study
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
9 sitesin 3 countries
Study dates
Apr 2001to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • No informed consent

Trial locations and contacts

9 sites in 3 countries.

Britt Edvardsen, AVD ING contact

+4755974200 ext. 6336

britt.edvardsen@helse-bergen.no

Ingjerd Bergo, Tech contact

+4755974200

ingjerd.bergo@helse-bergen.no

9 sites in 3 countries

Norway7 sites, 7 recruiting

  • Department of Gynecology, Ålesund Hospital

    Ålesund

    Margareth S. Lode, MD

    Recruiting

  • Sentralsykehuset i Førde

    Førde, N6807

    Tjugum Jostein, MD, PhD, +4757 83 90 00, jostein.tjugum@helse-forde.no

    Recruiting

  • Helse-Fonna, Haugesund Sjukehus

    Haugesund, N5528

    Klaus Oddenes, MD, Klaus.oddenes@helse-fonna.no

    Recruiting

  • Kvinneklinikken, Akershus Universitetssykehus

    Lørenskog, N1478

    Marie E Engh, Prof, m.e.engh@medisin.uio.no

    Recruiting

  • Kvinnesenteret, Ullevål Universitetssykehus

    Oslo, N0450

    Annetine Staff, MD PhD, annetine.staff@ulleval.no

    Recruiting

  • Sykehuset Vestfold HF

    Tønsberg, N3103

    Jan A. Rokne, MD, jan.anders.rokne@siv.no

    Recruiting

  • Department of Gynecology, St Olav's Hospital

    Trondheim, N7006

    Solveig Tingulstad, Prof, +4772574957, solveig.tingulstad@stolav.no

    Recruiting

Other trials in Norway

Belgium1 site, 1 recruiting

  • Gynecological Oncology, UZ Gasthuisberg

    Leuven, 3000

    Frederic Amant, MD, PhD, Frederic.amant@uz.kuleuven.ac.be

    Recruiting

Other trials in Belgium

Sweden1 site, 1 recruiting

  • Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital

    Gothenburg, SE-41345

    Janusz Marcickiewicz, MD, PhD, janusz.marcickiewicz@obgyn.gu.se

    Recruiting

Other trials in Sweden

About this study

Official title: Prospective Study of Endometrial Cancer Treatment in Relation to Molecular Markers in Curettage Specimens.

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.

Being tested
Tumor biopsy study
Keywords
Endometrial cancer, Molecular markers, Lymph node metastasis, Prospective study, Prognosis, Cancer of Endometrium, Tumor Markers, Biological
Medical subject headings
Endometrial Neoplasms, Neoplasm Metastasis, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumor biopsy studyProcedure or surgery

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

Study groups in NCT00598845
Study groupRoleWhat they receive
Consecutive numbersPatients with endometrial cancer
Receives: Procedure: Tumor biopsy study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of lymph node metastases

    Measured: At primary treatment

Secondary outcomes (1)

  1. Recurrent disease, death from disease

    Measured: 5 years after primary treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2008 (estimated)
  2. Study startApr 2001
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00598845
Sponsor's protocol ID
NSD 15501
Other IDs
NSD 15501, REK 96/1478-2, Helse Vest 911351
Acronym
MoMaTEC
Status last verified
Dec 2014
First submitted
26 Dec 2007
Last updated
23 Dec 2014
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Neoplasms and Neoplasm Metastasis, run by University of Bergen at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Norway, Belgium, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Britt Edvardsen, AVD ING (+4755974200 ext. 6336, britt.edvardsen@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of lymph node metastases (time frame: At primary treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00598845, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.

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