C18 C34 C16 C50 C25 C19 C15
Conditions
Interventions
Group 1: Patients, undergoing a colonoscopy and/or gastroscopy (endoscopy of the esophagus and stomach) (screening or diagnostic), collection of fluid biosamples like blood, urine, saliva, stool, brea
Sponsors
Nationales Centrum für Tumorerkrankungen (NCT) und Deutsches Krebsforschungszentrum (DKFZ)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: For the participants of arm A the following inclusion and exclusion criteria apply. Inclusion Criteria: • Women or men • Age 18 years or older, recruited under the Heidelberg Ethics vote • Appointment for a screening/diagnostic colonoscopy and / or gastroscopy (endoscopy of the esophagus and stomach) 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, - Recruitment under the Ethics Vote Heidelberg, from 18 years for all cancer entitites • Ability to speak and understand German • Provision of written informed consent
Exclusion criteria
Exclusion criteria: Arm A: Exclusion criteria: • Not able to understand and sign the informed consent form in person • Previous diagnosis of colorectal cancer (only for participants of colonoscopy) • Known diagnosis of Lynch syndrome or Familial Adenomatous Polyposis(only for participants of colonoscopy) • Known diagnosis of inflammatory bowel disease (Crohn’s disease, ulcerative colitis) (only for participants of colonoscopy) • Preceding colonoscopy within the past 5 years (only for participants of colonoscopy) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, esophageal cancer 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, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary aims include use of the biomarkers and biomarker signatures for risk assessment, risk stratification and prediction of prognosis and therapy response. | — |
Countries
Germany
Contacts
Public ContactUte Mons
Deutsches Krebsforschungszentrum (DKFZ) und Nationales Centrum für Tumorerkrankungen (NCT)
Outcome results
None listed