Molecular Markers in Treatment in Endometrial Cancer (MoMaTEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by University of Bergen
Sponsor:
Collaborators:
Helse Vest, Bergen, Norwayn
Norwegian Cancer Society
NFOG (Nordic Society for Obstetrics and Gynecology)
NSGO
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT00598845
First received: December 26, 2007
Last updated: August 5, 2011
Last verified: January 2010
  Purpose

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 Intervention
Endometrial Neoplasms
Neoplasm Metastasis
Procedure: Tumor biopsy study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Endometrial Cancer Treatment in Relation to Molecular Markers in Curettage Specimens.

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Presence of lymph node metastases [ Time Frame: At primary treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrent disease, death from disease [ Time Frame: 5 years after primary treatment ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 1000
Study Start Date: April 2001
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Consecutive numbers
Patients with endometrial cancer
Procedure: Tumor biopsy study
Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated.

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.

  Eligibility

Genders 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598845

Contacts
Contact: Britt Edvardsen, AVD ING +4755974200 ext 6336 britt.edvardsen@helse-bergen.no
Contact: Ingjerd Bergo, Tech +4755974200 ingjerd.bergo@helse-bergen.no

Locations
Belgium
Gynecological Oncology, UZ Gasthuisberg Recruiting
Leuven, Belgium, 3000
Contact: Frederic Amant, MD, PhD       Frederic.amant@uz.kuleuven.ac.be   
Norway
Sentralsykehuset i Førde Recruiting
Førde, Norway, N6807
Contact: Tjugum Jostein, MD, PhD    +4757 83 90 00    jostein.tjugum@helse-forde.no   
Helse-Fonna, Haugesund Sjukehus Recruiting
Haugesund, Norway, N5528
Contact: Klaus Oddenes, MD       Klaus.oddenes@helse-fonna.no   
Kvinneklinikken, Akershus Universitetssykehus Recruiting
Lørenskog, Norway, N1478
Contact: Marie E Engh, Prof       m.e.engh@medisin.uio.no   
Kvinnesenteret, Ullevål Universitetssykehus Recruiting
Oslo, Norway, N0450
Contact: Annetine Staff, MD PhD       annetine.staff@ulleval.no   
Department of Gynecology, St Olav's Hospital Recruiting
Trondheim, Norway, N7006
Contact: Solveig Tingulstad, Prof    +4772574957    solveig.tingulstad@stolav.no   
Sykehuset Vestfold HF Recruiting
Tønsberg, Norway, N3103
Contact: Jan A. Rokne, MD       jan.anders.rokne@siv.no   
Department of Gynecology, Ålesund Hospital Recruiting
Ålesund, Norway
Contact: Margareth S. Lode, MD         
Sweden
Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, SE-41345
Contact: Janusz Marcickiewicz, MD, PhD       janusz.marcickiewicz@obgyn.gu.se   
Sponsors and Collaborators
University of Bergen
Helse Vest, Bergen, Norwayn
Norwegian Cancer Society
NFOG (Nordic Society for Obstetrics and Gynecology)
NSGO
Investigators
Principal Investigator: Helga B. Salvesen, Prof., MD, PhD University of Bergen
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Helga B. Salvesen, The University of Bergen
ClinicalTrials.gov Identifier: NCT00598845     History of Changes
Other Study ID Numbers: NSD 15501, NSD 15501, REK 96/1478-2, Helse Vest 911351
Study First Received: December 26, 2007
Last Updated: August 5, 2011
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Bergen:
Endometrial cancer
Molecular markers
Lymph node metastasis
Prospective study
Prognosis
Cancer of Endometrium
Tumor Markers, Biological

Additional relevant MeSH terms:
Endometrial Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014