Trial document




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  DRKS00015530

Trial Description

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Title

Analysis of therapy-induced changes in gene expression, tumorigenicity and invasiveness of circulating, epithelial tumor cells (CETCs)

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The number of circulating, epithelial tumor cells in the blood of patients with colorectal carcinoma (Stage I-IV, initial diagnosis) is determined in the course of a guideline-dependent therapy. In case of a (guideline-conform) excision of the primary tumor, also gene expression and further parameters associated with tumorigenicity and invasiveness are analyzed before and after the surgical intervention, and compared to those properties of the cells from the primary tumor.

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Brief Summary in Scientific Language

Prospective analysis of the progress of number, gene expression, tumorigenicity, and invasiveness of circulating epithelial tumor cells (CETC) in the blood of patients with initially diagnosed colorectal carcinoma (C18-20, stage I-IV) while under therapy compliant with guidelines. For patients receiving guidelines-conform surgery of the primary tumor a comparison with the corresponding properties of the cells of the latter is envisaged.

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Organizational Data

  •   DRKS00015530
  •   2018/09/13
  •   [---]*
  •   yes
  •   Approved
  •   O 1305/1 GB, Ethikkommission der Universität Bayreuth
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Patients with colorectal carcinoma stages I-IV; determination of the CETC number from residual tissue (blood): 1 week before the first treatment, and 2 weeks after the last treatment of a neoadjuvant chemotherapy respectively, and/or 1 week before and 6-8 weeks after a guideline-conform excision of the primary tumor, and/or 1 week before the first treatment, and two weeks after the last treatment of a adjuvant/palliative chemotherapy respectively.
    For patients receiving guidelines-conform surgical tumor resection: comparison of the specific gene expression profiles of CETC and cells from the primary tumor explant.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

CETC numbers in the course of guideline-conform treatment of colorectal carcinoma (stage I-IV) (Maintrac protocol);
gene expression, tumorigenicity and invasivity of CETCs (and if applicable primary tumor cells) in the course of guideline-conform therapy of colorectal carcinoma (single cell picking, PCR, pysical and biochemical assays); overall survival (follow up after 3 and 5 years via cancer registry) and progression-free survival (follow up after 3 and 5 years via cancer registry)

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Secondary Outcome

Comparison of gene expression, tumorigenic and invasive properties of CETCs with those of primary tumor cells (single cell picking, PCR, physical and biochemical assays)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/09/11
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   100   Years
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Additional Inclusion Criteria

histologically verified, invasive colorectal carcinoma (C18, C19, C20); initial diagnosis; stage I-IV; medical treatment in the Hospital Bayreuth, only; minimum 2 blood withdrawals (before and after a guideline-conform radio/chemotherapy or surgery)

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Exclusion Criteria

lack of consent; unrelated, preceding malignancies < 10 years before the diagnosis of the colorectal carcinoma; pregnancy

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Addresses

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    • Universität Bayreuth
    • Universitätsstraße 30
    • 95440  Bayreuth
    • Germany
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    •   [---]*
    •   [---]*
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    • Simfo GmbH
    • Kurpromenade 2
    • 95448  Bayreuth
    • Germany
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    • Organische Chemie I, Universität Bayreuth
    • Mr.  Prof. Dr.  Rainer  Schobert 
    • Universitätsstraße 30
    • 95440  Bayreuth
    • Germany
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    • Klinik für Onkologie und Hämatologie Klinikum Bayreuth
    • Mr.  Prof. Dr. med.  Alexander  Kiani 
    • Preuschwitzer Straße 101
    • 95445  Bayreuth
    • Germany
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Sources of Monetary or Material Support

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    • Graduiertenstipendium nach dem Bayerischen Eliteförderungsgesetz (BayEFG)
    • Universitätsstraße 30
    • 95440  Bayreuth
    • Germany
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    • Organische Chemie I, Universität Bayreuth
    • Mr.  Prof. Dr.  Rainer  Schobert 
    • Universitätsstraße 30
    • 95440  Bayreuth
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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