Molecular Markers in Treatment in Endometrial Cancer (MoMaTEC)

December 22, 2014 updated by: Helga B Salvesen, University of Bergen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
  • Norway
      • Førde, Norway, N6807
      • Haugesund, Norway, N5528
      • Lørenskog, Norway, N1478
        • Recruiting
        • Kvinneklinikken, Akershus Universitetssykehus
        • Contact:
      • Oslo, Norway, N0450
      • Trondheim, Norway, N7006
        • Recruiting
        • Department of Gynecology, St Olav's Hospital
        • Contact:
      • Tønsberg, Norway, N3103
      • Ålesund, Norway
        • Recruiting
        • Department of Gynecology, Ålesund Hospital
        • Contact:
          • Margareth S. Lode, MD
  • Sweden
      • Gothenburg, Sweden, SE-41345
        • Recruiting
        • Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of lymph node metastases
Time Frame: At primary treatment
At primary treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrent disease, death from disease
Time Frame: 5 years after primary treatment
5 years after primary treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Norwegian Cancer Society
Helse-Bergen HF

Investigators

  • Principal Investigator: Helga B. Salvesen, Prof., MD, PhD, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

January 23, 2008

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSD 15501
  • REK 96/1478-2
  • Helse Vest 911351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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