The DARIO Study was a large-scale scientific study conducted at the National Center for Tumor Diseases (NCT) Heidelberg in collaboration with the Interdisciplinary Endoscopy Center Heidelberg (IEZ) at the Medical Clinic in Heidelberg.
The study has already been completed. We are not recruiting any more participants.
DARIO Study
Colorectal Cancer Prevention: Innovative Ways at the NCT Heidelberg
Aim of the study
The study’s main objective was to discover and evaluate new screening tests that can detect cancer and its precursors earlier.
In addition, we wanted to find out:
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How well received is the offer of a colonoscopy in the age group of 50 and 54 years, and what results are found? A colonoscopy examines the colon for polyps and suspicious changes.
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Which type of colonoscopy is preferred? Either the mirroring of the entire colon (colonoscopy), or a sigmoidoscopy, the so-called "small colonoscopy," which is less complex but examines only part of the colon?
Participants in the DARIO study did not commit to any examination. They were always able to only participate in the study parts involving answering a questionnaire on diet and lifestyle or providing biosamples for the development of simple screening tests. However, with the colonoscopy, they received an offer which most health insurers do not include without extra costs for people in this age group.
Early detection increases the chances of cure for most cancers significantly. Colorectal cancer can be prevented through screening.
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We contacted 12,000 men and women aged 50-54 years in the Rhine-Neckar region (a sampling approved for scientific surveys according to §46 of the Federal Registration Act (BMG)), whom we interviewed with a questionnaire about previously performed colorectal cancer/preventive examinations as well as lifestyle factors. All contacted participants were randomly assigned to study arm A or B (study part I).
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If the inclusion criteria had been met, the participant was invited to study part II. In arm A, we offered a free large colonoscopy. In arm B, participants had the choice of a free large (screening colonoscopy) or small colonoscopy (screening sigmoidoscopy) (study part II). The participant contacted the DARIO study center and scheduled an appointment for a preliminary talk or information regarding colonoscopy. Participation within either the study or study part I or even in the preliminary talk did not obligate participants to undergo a colonoscopy nor to participate in further study parts. Only after participants had been informed about the procedure on-site at the NCT Heidelberg/IEZ and had given their consent, an appointment for a colonoscopy was scheduled.
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At this appointment, the participant was asked for consent for study part III, during which biosamples (blood, stool, urine, and saliva) were collected for screening markers. Participation in study part III was also possible without participation in study part II (preliminary interview and colonoscopy).
Note: With colonoscopy, study participants received an offer that most health insurers would not pay for individuals in this age group.
The study started in September 2016 and was coordinated by the Department of Preventive Oncology at the NCT Heidelberg.
Informing and enrolling participants in the study took place at the DARIO Study Center at the NCT Heidelberg.
Endoscopic examinations were performed by our cooperation partners at the Interdisciplinary Endoscopy Center at the Heidelberg University Hospital, Medical Clinic (INF 410):
Interdisciplinary Endoscopy Center Heidelberg,
Prof. Dr. Peter Sauer, senior physician Dr. Anja Schaible, MSc,
Im Neuenheimer Feld 410,
69120 Heidelberg,
www.iez-heidelberg.de
Contact
If you have any questions about the study, please do not hesitate to contact us at any time.
DARIO Study Team
National Center for Tumor Diseases (NCT) Heidelberg
Preventive Oncology
Im Neuenheimer Feld 460
69120 Heidelberg
Phone: 06221-56 – 34322
E-mail: dario@nct-heidelberg.de
Projekt Management
Prof. Dr. med. Hermann Brenner
German Cancer Research Center (DKFZ)
Division of Clinical Epidemiology and Aging Research
Im Neuenheimer Feld 581 and
National Center for Tumor Diseases (NCT) Heidelberg
Im Neuenheimer Feld 460
Preventive Oncology
69120 Heidelberg
Study Coordination
Dr. Petra Schrotz-King
National Center for Tumor Diseases (NCT) Heidelberg
Preventive Oncology
Im Neuenheimer Feld 460
69120 Heidelberg