Trial document





This trial has been registered retrospectively.
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  DRKS00010931

Trial Description

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Title

Do not give cancer a chance - Onkocheck (GEKKO)

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Trial Acronym

GEKKO

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URL of the Trial

https://www.nct-heidelberg.de/gekko

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Brief Summary in Lay Language

The GEKKO study is a large-scale scientific study conducted at the National Center for Tumor Diseases (NCT) in cooperation with gastroenterological cooperation partners and associated clinics in Heidelberg and the surrounding area. The aim of the study is to discover and evaluate new screening tests that can detect cancer and its precursors earlier, because early detection will increase the chance of cure for most cancers.

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Brief Summary in Scientific Language

The aim of the GEKKO study is to set up a platform for the evaluation of biomarkers for early cancer detection and prognosis. In arm A, participants are recruited who participate in a screening colonoscopy. In arm B primary diagnosed patients are recruited who come to the hospital for the first treatment of a newly diagnosed tumor.

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Organizational Data

  •   DRKS00010931
  •   2018/10/08
  •   [---]*
  •   yes
  •   Approved
  •   S-392/2015, 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
  •   C34 -  Malignant neoplasm of bronchus and lung
  •   C16 -  Malignant neoplasm of stomach
  •   C50 -  Malignant neoplasm of breast
  •   C25 -  Malignant neoplasm of pancreas
  •   C19 -  Malignant neoplasm of rectosigmoid junction
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Interventions/Observational Groups

  •   Screening a colonoscopy (Screening and Diagnostic), Collection of fluid Biosamples like blood, urine, saliva, stool, breath condensate.
    Questionnaires on life style and health behaviour.
  •   Primarily diagnosed cancer patients
    (Breast, intestine, gastrointestinal, lung)
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary aim of this screening/diagnostic study is to estimate diagnostic performance (sensitivity, specificity, ROC curves, area under the curve etc.) of biomarkers and biomarker signatures for detecting colorectal neoplasms, other gastrointestinal cancers and selected other cancers such as breast and lung cancer.
Analyses of diagnostic performance for and risk of colorectal cancer and its precursors (colorectal adenomas, in particular advanced colorectal adenomas) will be conducted by comparing participants of colonoscopy with and without the various types of colorectal neoplasms within study arm A.

Further analyses of diagnostic performance for and risk of colorectal cancer as well as other gastrointestinal cancers and selected other cancers such as breast and lung cancer will be conducted by comparing newly diagnosed patients with various cancers in study arm B with samples of participants free of colorectal neoplasms from study arm A. To ensure comparability of groups, we will employ matching for sex and age in selecting neoplasm-free control groups from study arm A. Finally, performance of biomarkers for predicting prognosis will be assessed among patients recruited in study arm B.

The biospecimen collected in this long-term study will be used for identifying and evaluating biomarkers and biomarker signatures for cancer early detection, risk assessment and prediction of prognosis and therapy response. Examples of measurements anticipated at this time include measurements of defined metabolites in blood, stool, urine, breath, breath condensate and saliva, circulating RNA (Ribonucleic acid) and DNA (Deoxyribonucleic acid) for example in blood samples, SNP analyses, application of several available and emerging –omics technologies, such as genomics, epigenomics, serolomics, proteomics, metabolomics, stool metagenomics, next generation sequencing and transcriptomics of tumor tissue and immunological assays, immunohistochemistry on tissue, tissue cultures including primary cell cultures (for example tumor cells, macrophages, fibroblasts) for functional assays (e.g., proliferation assays, apoptosis assays, adhesion assays) to investigate in vitro as an alternative to animal models the response to therapeutic agents, for example in the presence of specific biomarkers influencing therapy response.

Also included are questionnaires on lifestyle (diet, exercise, prevention, illness, medication).

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Secondary Outcome

Secondary aims include use of the biomarkers and biomarker signatures for risk assessment, risk stratification and prediction of prognosis and therapy response.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/01/18
  •   20000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

For the participants of arm A the following inclusion and exclusion criteria apply.
Inclusion Criteria:
• Women or men
• Age 30 years or older
• Appointment for a screening/diagnostic colonoscopy at a NCT Collaborative Practice
• Willingness to schedule a separate outpatient visit at the NCT or participate in the study recruitment at the NCT Collaborative Practice or Clinic
• Ability to speak and understand German
• Provision of written informed consent


For the patients of arm B the following inclusion and exclusion criteria apply.
Inclusion criteria:
• Newly diagnosed gastrointestinal cancer (including also GIST and Insulinoma),
• Other gastrointestinal diseases for which differential diagnosis with gastrointestinal cancers is relevant , such as acute and chronic pancreatitis (AP, CP),
• Intraductal mucinous neoplasm of the pancreas (IPMN),
• Space requirements in the digestive tract
• “Suspicion of” (any of the in the inclusion criteria mentioned diseases) diagnosis
• Selected newly diagnosed other cancers such as lung or breast cancer
• Women or men
• Age 25 years or older for breast cancer patients
• Age 30 or older for all other cancer patients
• Ability to speak and understand German
• Provision of written informed consent

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Exclusion Criteria

Arm A:
Exclusion criteria:
• Not able to understand and sign the informed consent form in person
• Previous diagnosis of colorectal cancer
• Known diagnosis of Lynch syndrome or Familial Adenomatous Polyposis
• Known diagnosis of inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
• Preceding colonoscopy within the past 5 years

Arm B:
Exclusion criteria:
• Inflammatory bowel disease such as crohn's disease and ulcerative colitis
• Not able to understand and sign the informed consent form in person
• Recurrent tumor disease

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Addresses

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    • Nationales Centrum für Tumorerkrankungen (NCT) und Deutsches Krebsforschungszentrum (DKFZ)
    • 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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    • Abteilung Präventive Onkologie, Nationales Centrum für Tumorerkrankungen (NCT) und Deutsches Krebsforschungszentrum (DKFZ)
    • GEKKO  Studie  NCT/DKFZ 
    • Abteilung Präventive Onkologie Im Neuenheimer Feld 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.  Stiftung 
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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Status

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

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