Trial document




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  DRKS00012571

Trial Description

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Title

GynTect® as prognostic marker -
longitudinal observational study by patients with CIN2/3

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Trial Acronym

GynTect-PRO

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URL of the Trial

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Brief Summary in Lay Language

Evaluation of GynTect® , a test for the detection of methylated DNA regions in cell scrapes of the uterine Cervix, as a prognostic marker for regression of pre-cancerous lesions.
Not every pre-cancerous lesion of the cervix (CIN2/3) develops into cancer. In particular among young women (˂ 30 years) about 60% of the lesions regress spontaneously.
We hypothesize that lesions which are negative for the GynTect® markers will regress within a period of watchful waiting, whereas lesions which are positive for the GynTect® markers will persist or progress. This study includes patients in the age group 18-24 years who have decided to undergo watchful waiting rather than immediate treatment. For these patients the rest material of the cervical scrapes taken for routine diagnostic purposes will be analyzed using the GynTect® assay. All patients will undergo routine gynecological visits according to the current guidelines every 6 months for a period of 12 to 24 months to observe regression, persistence or progression of the lesion. The results obtained for the GynTect® assay serves to evaluate proof of concept and does not influence in any way the therapy decision.

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Brief Summary in Scientific Language

“Proof of concept” study to determine the prognostic potential of GynTect® (a set of methylation markers) among women diagnosed with CIN2/3.
Not every dysplastic lesion (CIN2/3) develops into cancer. In particular among young women (˂ 30 years) up to 60% of lesions regress spontaneously. We hypothesize that lesions which lack a characteristic methylation signature, referred to as GynTect® markers, will regress spontaneously whereas lesions which are GynTect® positive will either persist or even progress. The follow-up of the study ranges from12 to 24 month. The results obtained for the GynTect® assay serves to evaluate proof of concept and do not in any way influence therapy decision.

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Organizational Data

  •   DRKS00012571
  •   2017/09/29
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  •   yes
  •   Approved
  •   5166-05/17, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   N87.1 -  Moderate cervical dysplasia
  •   D06.1 -  Carcinoma in situ: Exocervix
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Interventions/Observational Groups

  •   The GynTect-PRO study is a prospective multicenter observational study. The observational group contains patients with histopathological confirmed CIN2 /3 lesions who have decided to pursue watchful waiting. At the time point of diagnosis and every 6 months within routine observation according to current guidelines, the rest material of the cervical scrapes is analyzed for methylation markers (GynTect ® assay). The observation period for patients with CIN2 is up to 24 months, for patients with CIN3 up to 12 months. The GynTect ® results have no influence on treatment decisions which are solely based on routine diagnostics.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Prognostic marker: Result of the GynTect® markers at the time point of diagnosis.
Regression of CIN2/3 within 1 year (CIN3) and 2 years (CIN2), respectively. For CIN2 regression is defined as ≤CIN1 as determined by cytology or colposcopy or if unclear by histopathology. For CIN3 regression is defined as ≤CIN2 as determined by cytology or colposcopy or if unclear by histopathology.

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Secondary Outcome

Persistence or progression of CIN2/3 within 1 year (CIN3) and 2 years (CIN2), respectively. For CIN2 persistence and progression is defined as CIN2 or ˃CIN2, respectively as determined by cytology and histopathology. For CIN3 persistence and progression is defined as CIN3 or ˃CIN3, respectively as determined by cytology and histopathology.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/12/20
  •   74
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   24   Years
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Additional Inclusion Criteria

Women ≥18 years and ˂25years with histopathologic confirmed CIN2 or CIN3. The entire lesion has to be visible by colposcopy and is free of gladular atypia. An invasive component of the lesion can be excluded with high certainty. Informed written consent.

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Exclusion Criteria

Women with lesions where the entire squamous-glandular junction is not visible. Women with glandular atypia and cases in which an invasive component of the lesion cannot be excluded. Pregnancy.

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Addresses

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    • Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
    • Prof.   Matthias  Dürst 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
    • Mr.  Prof.  Matthias  Dürst 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
    • Mr.  Prof.  Matthias  Dürst 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • oncgnostics GmbH
    • Winzerlaer Str. 2
    • 07745  Jena
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.