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Molecular Markers in Treatment in Endometrial Cancer (MoMaTEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598845
Recruitment Status : Unknown
Verified December 2014 by Helga B Salvesen, University of Bergen.
Recruitment status was:  Recruiting
First Posted : January 23, 2008
Last Update Posted : December 23, 2014
Helse-Bergen HF
Norwegian Cancer Society
Information provided by (Responsible Party):
Helga B Salvesen, University of Bergen

Brief 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.

Condition or disease Intervention/treatment
Endometrial Neoplasms Neoplasm Metastasis Procedure: Tumor biopsy study

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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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Endometrial Cancer Treatment in Relation to Molecular Markers in Curettage Specimens.
Study Start Date : April 2001
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2017

Group/Cohort Intervention/treatment
Consecutive numbers
Patients with endometrial cancer
Procedure: Tumor biopsy study
Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated.

Primary Outcome Measures :
  1. Presence of lymph node metastases [ Time Frame: At primary treatment ]

Secondary Outcome Measures :
  1. Recurrent disease, death from disease [ Time Frame: 5 years after primary treatment ]

Biospecimen Retention:   Samples With DNA
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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:

  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598845

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Contact: Britt Edvardsen, AVD ING +4755974200 ext 6336
Contact: Ingjerd Bergo, Tech +4755974200

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Gynecological Oncology, UZ Gasthuisberg Recruiting
Leuven, Belgium, 3000
Contact: Frederic Amant, MD, PhD   
Sentralsykehuset i Førde Recruiting
Førde, Norway, N6807
Contact: Tjugum Jostein, MD, PhD    +4757 83 90 00   
Helse-Fonna, Haugesund Sjukehus Recruiting
Haugesund, Norway, N5528
Contact: Klaus Oddenes, MD   
Kvinneklinikken, Akershus Universitetssykehus Recruiting
Lørenskog, Norway, N1478
Contact: Marie E Engh, Prof   
Kvinnesenteret, Ullevål Universitetssykehus Recruiting
Oslo, Norway, N0450
Contact: Annetine Staff, MD PhD   
Department of Gynecology, St Olav's Hospital Recruiting
Trondheim, Norway, N7006
Contact: Solveig Tingulstad, Prof    +4772574957   
Sykehuset Vestfold HF Recruiting
Tønsberg, Norway, N3103
Contact: Jan A. Rokne, MD   
Department of Gynecology, Ålesund Hospital Recruiting
Ålesund, Norway
Contact: Margareth S. Lode, MD         
Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, SE-41345
Contact: Janusz Marcickiewicz, MD, PhD   
Sponsors and Collaborators
University of Bergen
Helse-Bergen HF
Norwegian Cancer Society
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Principal Investigator: Helga B. Salvesen, Prof., MD, PhD University of Bergen
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Helga B Salvesen, Professor, MD, PhD, University of Bergen Identifier: NCT00598845    
Other Study ID Numbers: NSD 15501
NSD 15501
REK 96/1478-2
Helse Vest 911351
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Helga B Salvesen, University of Bergen:
Endometrial cancer
Molecular markers
Lymph node metastasis
Prospective study
Cancer of Endometrium
Tumor Markers, Biological
Additional relevant MeSH terms:
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Neoplasm Metastasis
Endometrial Neoplasms
Neoplastic Processes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases