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Molecular Markers in Treatment in Endometrial Cancer

NCT ID: NCT00598845

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endometrial Neoplasms Neoplasm Metastasis

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Consecutive numbers

Patients with endometrial cancer

Tumor biopsy study

Intervention Type PROCEDURE

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

Interventions

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Tumor biopsy study

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No informed consent
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Helse-Bergen HF

OTHER

Sponsor Role collaborator

Norwegian Cancer Society

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Helga B Salvesen

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helga B. Salvesen, Prof., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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Gynecological Oncology, UZ Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

Department of Gynecology, Ålesund Hospital

Ålesund, , Norway

Site Status RECRUITING

Sentralsykehuset i Førde

Førde, , Norway

Site Status RECRUITING

Helse-Fonna, Haugesund Sjukehus

Haugesund, , Norway

Site Status RECRUITING

Kvinneklinikken, Akershus Universitetssykehus

Lørenskog, , Norway

Site Status RECRUITING

Kvinnesenteret, Ullevål Universitetssykehus

Oslo, , Norway

Site Status RECRUITING

Department of Gynecology, St Olav's Hospital

Trondheim, , Norway

Site Status RECRUITING

Sykehuset Vestfold HF

Tønsberg, , Norway

Site Status RECRUITING

Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Belgium Norway Sweden

Central Contacts

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Britt Edvardsen, AVD ING

Role: CONTACT

Phone: +4755974200

Email: [email protected]

Ingjerd Bergo, Tech

Role: CONTACT

Phone: +4755974200

Email: [email protected]

Facility Contacts

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Frederic Amant, MD, PhD

Role: primary

Margareth S. Lode, MD

Role: primary

Tjugum Jostein, MD, PhD

Role: primary

Klaus Oddenes, MD

Role: primary

Marie E Engh, Prof

Role: primary

Annetine Staff, MD PhD

Role: primary

Solveig Tingulstad, Prof

Role: primary

Jan A. Rokne, MD

Role: primary

Janusz Marcickiewicz, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 16677592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16540684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16330673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15051772 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12460889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10334522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19800606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19261849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18552176 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23932335 (View on PubMed)

Related Links

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http://www.nsgo.org/

Nordic Society of Gynecologic Oncology

Other Identifiers

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NSD 15501

Identifier Type: -

Identifier Source: secondary_id

REK 96/1478-2

Identifier Type: -

Identifier Source: secondary_id

Helse Vest 911351

Identifier Type: -

Identifier Source: secondary_id

NSD 15501

Identifier Type: -

Identifier Source: org_study_id