Molecular Markers in Treatment in Endometrial Cancer (MoMaTEC)
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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. |
- Presence of lymph node metastases [ Time Frame: At primary treatment ] [ Designated as safety issue: No ]
- 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 |
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
Contacts and Locations| Contact: Britt Edvardsen, AVD ING | +4755974200 ext 6336 | britt.edvardsen@helse-bergen.no |
| Contact: Ingjerd Bergo, Tech | +4755974200 | ingjerd.bergo@helse-bergen.no |
| 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 | |
| Principal Investigator: | Helga B. Salvesen, Prof., MD, PhD | University of Bergen |
More Information
Additional Information:
Publications:
| 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:
|
Neoplasms Endometrial Neoplasms Neoplasm Metastasis Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Diseases Genital Diseases, Female Neoplastic Processes Pathologic Processes Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013