Trial document





This trial has been registered retrospectively.
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  DRKS00005982

Trial Description

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Title

MicroRNA Signatures

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Analysis and comparison of blood-derived microRNA profiles in patients with diverticulitis, intestinal polyps and early (UICCi-II), lymphogen (UICC III) and hematogen metastasised (UICC IV) stage colorectal cancer as well as normal subjects (control group)

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Brief Summary in Scientific Language

This project in cooperation with the DKFZ (German Cancer Research Center) Heidelberg is designed to analyse and compare blood-derived microRNA profiles in patients with early (UICC I-II) or late (UICC III-IV) stage colorectal cancer as well as in patients with diverticulitis or intestinal polyps. In addition, data will be compared with normal subjects as a control group. The aim of the study is to identify a microRNA signature for colorectal cancer in this training set which could potentially be used for early detection and differential diagnosis of colorectal cancer.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005982
  •   2014/04/02
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  •   yes
  •   Approved
  •   PV4594, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

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

  •   Single blood sample for analysis and comparison of the microRNA profiles in patients with diverticulitis, intestinal polyps and early (UICC I-II), lymphogen (UICC III) and hematogen metastasised (UICC IV) stage colorectal cancer as well as normal subjects (control group)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Analysis of microRNA profiles in blood samples of patients with diverticulitis, intestinal polyps and different stages of colorectal cancer.

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Secondary Outcome

- Assessment of a predictive microRNA signature for (early) colorectal cancer
- Assessment of the sensitivity and specificity of the microRNA signature
- Assessment of microRNA signatures for different tumor stages
- Assessment of the discriminatory power of the microRNA analysis for the differential diagnosis colorectal cancer versus diverticulitis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/02/25
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Age >/= 18 years
Written informed consent
Primary diagnosis of a histological confirmed adenocarcinoma of the colon or rectum
Or
Acute diverticulitis (verified by CT, Stage I + IIa according to Hansen and Stock)
Or
Intestinal polyps for endoscopic polypectomy (R0 stage and benign histology)
Or
Subjects without malignant or inflammatory intestinal diseases (normal subjects)

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Exclusion Criteria

- History of secondary malignancy within the past 5 years
- Acute or subacute ileus
- Known chronic-inflammatory bowel disease
- Chemotherapy within 2 weeks prior to enrolment
- Treatment with steroids or other immune suppressive drugs
- Relevant adverse drug reactions of concomitant medications
- Non-healing wounds, ulceration or bone fractures
- Pregnancy or lactation
- For patients with colorectal cancer: ALAT and ASAT > 2.5 ULN, serum bilirubin > 1.5 ULN, serum creatinine > 1.5 ULN
- Significant concomitant disease that excludes study participation according to the investigator
- Medical or psychiatric disability which prevents proper informed consent
- Missing or limited legal capacity

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Addresses

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    • Deutsches Krebsforschungszentrum
    • Im Neuenheimer Feld 580
    • 69120  Heidelberg
    • Germany
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    • Asklepios Klinik Barmbek, Onkologie und Palliativmed.
    • Mr.  Dr.  Axel  Stang 
    • Rübenkamp 220
    • 22291  Hamburg
    • Germany
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    • Asklepios Klinik Barmbek, Onkologie und Palliativmed.
    • Mr.  Dr.  Axel  Stang 
    • Rübenkamp 220
    • 22291  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Krebsforschungszentrum
    • Im Neuenheimer Feld 580
    • 69120  Heidelberg
    • Germany
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    • Asklepios Kliniken Hamburg, Forschungsförderung
    • Rübenkamp 226
    • 22307  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/17
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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.