Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00018932

Trial Description

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Title

Colon Cancer Prevention - Innovative Strategies at the NCT

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Trial Acronym

DARIO

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URL of the Trial

https://www.nct-heidelberg.de/fuer-aerzte/studien/praeventiv/dario.html

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Brief Summary in Lay Language

The DARIO study is a large-scale scientific study carried out at the National Center for Tumor Diseases (NCT) in cooperation with the Interdisciplinary Endoscopy Center Heidelberg (IEZ) at the Medical Clinic in Heidelberg.
The main goal of the study is to discover and evaluate new screening tests that can help detect cancer and its precursors earlier.
In addition, we want to find out how well the offer of colonoscopy, which examines the colon for polyps and suspicious changes, is accepted in the age group 50-54 and what results are found. We also examine which type of colonoscopy is preferred, colonoscopy or sigmoidoscopy.

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Brief Summary in Scientific Language

DARIO pursues the following goals in 3 study parts:
Study Part I is a cross-sectional epidemiological study that uses a standardized questionnaire to investigate the nature, frequency, timing, and results of previous colorectal cancer screening and eventual diagnostic colonoscopies in a random sample of 50-54 year old men and women, in total, and depending on the risk factor profile for colorectal cancer.

Study part II is a randomized intervention trial in which potentially suitable and interested participants from study part I are randomized into two groups: participants in arm A are offered a free screening colonoscopy, participants in arm B can choose between a free screening colonoscopy or screening sigmoidoscopy. The goal is to investigate whether and to what extent the extension of the screening offer for less invasive sigmoidoscopy leads to a higher use of endoscopic screening and a higher number of detected and removed neoplasms (primary endpoint: number of detected and removed colorectal neoplasms > 0,5 cm).

In addition, Part III of the study will use samples from participants in Study Part II to construct a Liquid and Tissue Biobank for the evaluation of less invasive methods of early detection of colon cancer and for the more detailed characterization of the detected neoplasms. Blood, urine, stool and saliva samples are taken before the endoscopy. Tissue samples are obtained from the neoplasms removed during endoscopy.

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Organizational Data

  •   DRKS00018932
  •   2019/10/31
  •   [---]*
  •   yes
  •   Approved
  •   S-686/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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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

  •   Screening patients of a colonoscopy (screening and diagnostic), Biosamples taken are: blood, urine, saliva, stool. Questions about lifestyle and health behavior.
  •   Screening patients of a colonoscopy or sigmoidoscopy (screening and diagnostic), biosamples taken: blood, urine, saliva, stool. Questions about lifestyle and health behavior.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Screening
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Study Part I:
Frequency of previous early detection examinations.
Collected at the end of the study as soon as all questionnaire data have been recorded, checked for plausibility and evaluated.

Study Part II:
Proportion of participants in whom colorectal neoplasms > 0.5 cm that are detected and removed at screening endoscopy.
Collected at the end of the study as soon as all endoscopy data have been recorded, checked for plausibility and evaluated.

Study Part III:
Sensitivity, specificity, positive and negative predictive values, area under the curve (AUC) of diagnostic tests for detection of CRC and colorectal adenomas.
Collected after the end of the study, as soon as bioprobes and associated medical data are included in biosamples analyses of different kinds (for example, metabolomics, proteomics, miRNA, SPS, Expression analysis, sequencing).

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Secondary Outcome

Utilization rate of any screening endoscopy.
Detection rate of any neoplasm.
Patient preference with respect to type of screening endoscopy (proportion).
Safety of the applied procedures, complication rates (established routine procedures, standard monitoring of complications).

Collected at the end of the study as soon as all endoscopy data has been recorded, checked for plausibility and evaluated.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/09/01
  •   3000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   54   Years
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Additional Inclusion Criteria

Women or men
- Age 50 (>49) to 54 (<55) at the day of invitation to the study
- Main residence in Heidelberg, Mannheim and Rhine-Neckar-Kreis (as defined by community codes)
- Ability to speak and understand German language
- Ability to give legally binding informed consent

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Exclusion Criteria

Participants, who have a history of colorectal cancer.
- have had a colonoscopy in the previous 5 years.
- have a history of FAP (Familial Adenomatous Polyposis) or Lynch Syndrome.
- are severely ill and not able to visit the IEZ

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Addresses

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    • Nationales Centrum für Tumorerkrankungen (NCT) und Deutsches Krebsforschungszentrum (DKFZ)
    • Mr.  Prof. Dr. med.  Hermann  Brenner 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • Interdisziplinäres Endoskopiezentrum der Universitätsklinik Heidelberg
    • Mr.  Prof. Dr. med.  Peter  Sauer 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    • Nationales Centrum für Tumorerkrankungen (NCT) und Deutsches Krebsforschungszentrum (DKFZ)
    • Mr.  Prof. Dr. med.  Hermann  Brenner 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • DARIO Studie, Abteilung Präventive Onkologie, NCT/DKFZ Im Neuenheimer Feld 460 69120 Heidelberg Deutschland
    • Ms.  Dr.  Petra  Schrotz-King 
    • INF 460
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • DKFZ/NCT Heidelberg
    • Mr.  Prof. Dr. med.  Hermann  Brenner 
    • Im Neuenheimer Feld 581
    • 69120  Heidelberg
    • Germany
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    • Stiftung Deutsche Krebshilfe
    • Ms. 
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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    • IEZ der Universitätsklinik Heidelberg
    • Mr.  Prof. Dr. med.  Peter  Sauer 
    • INF 410
    • 69120  Heidelberg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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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.