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Biomarkerscreening in Cervical Cancer and Its Preinvasive Lesions

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02238990
Recruitment Status : Recruiting
First Posted : September 12, 2014
Last Update Posted : May 3, 2018
Information provided by (Responsible Party):
Daniel Alexander Beyer, University of Luebeck

Brief Summary:

The following trial is a multicenter and prospective research trial of the colposcopy unit of luebeck university and the national research center in Borstel, Germany.

The study is to identify and evaluate new biomarkers in human papilloma virus (HPV) associated malignancies and its preinvasive lesions of the cervix uteri. Fresh tissue samples being removed during conizations and/or hysterectomies are to be fixed in HOPE`s solution and analyzed according to their transcriptomes and methylosome. The hereby found candidates are to be validated using immunohistochemistry and RT [real-time] -PCR [polymerase chain reaction].

The project is meant to be followed by continuous studies developing a new test describing the malignant potential of HPV associated genital lesions.

Condition or disease
Evaluation of New Tissue Biomarkers for Cervical Cancer

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkerscreening Via Transcriptome and Methylosome Analysis in Cervical Cancer and Its Preinvasive Lesions
Study Start Date : September 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Primary Outcome Measures :
  1. CIN III (cervical intraepithelial neoplasia) lesions [ Time Frame: three years ]
    number of CIN III lesions

  2. cervical cancer [ Time Frame: three years ]
    number of cervical cancer probes

  3. HPV [ Time Frame: three years ]
    number and type of HPV infection of the analyzed probes

Biospecimen Retention:   Samples With DNA
tissue samples of the cervix uteri

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:   Yes
Sampling Method:   Probability Sample
Study Population
The population is to be recruted from A. patients suffering from cervical cancer B. patients suffering from preinvasive cervical lesions

Inclusion Criteria:

  • Positive informed consent
  • Patients with suspected preinvasive genital lesion
  • Patients with confirmed genital lesion (both preinvasive and invasive)
  • Contact via dept. of obs/gyn of luebeck university
  • Complete set of data

Exclusion Criteria:

  • Incomplete set of data
  • Negative 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): NCT02238990

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Contact: Daniel Beyer, PD Dr. +49 451 500 2141

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Luebeck University, Department for obstetrics and gynecology Recruiting
Luebeck, Schleswig Holstein, Germany, D-23538
Contact: Daniel Beyer, PD Dr.    +49 451 500 2141   
Contact: Torsten Goldmann, Prof. Dr.    + 49 4537 188 230   
Principal Investigator: Daniel Beyer, PD Dr.         
Principal Investigator: Torsten Goldmann, Prof. Dr.         
Sponsors and Collaborators
University of Luebeck
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Principal Investigator: Daniel Beyer, PD Dr. University of Luebeck
Principal Investigator: Torsten Goldmann, Prof. Dr. Forschungszentrum Borstel

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Responsible Party: Daniel Alexander Beyer,, University of Luebeck Identifier: NCT02238990     History of Changes
Other Study ID Numbers: UKSH-HL-14-099
UKSH-HL-14-099 ( Other Identifier: Ethicscomittee Luebeck 14-099 )
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female