Preventing early-onset colorectal cancer
Organizational Data
- DRKS-ID:
- DRKS00029324
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-07-19
- Last update in DRKS:
- 2023-05-04
- Registration type:
- Prospective
Acronym/abbreviation of the study
PEARL
URL of the study
Brief summary in lay language
The BMBF-funded collaborative project PEARL aims to gain new insights into the understanding of risk factors and causes of colorectal cancer in young adults <50 years (early-onset colorectal cancer [EOCRC]) in order to develop and evaluate effective strategies for primary and secondary prevention in this age group. The consortium is conducting a large population-based case-control study of EOCRC in Germany with 800 colorectal cancer cases and 800 non-colorectal cancer control subjects aged 18-49 years.
Brief summary in scientific language
Population-based case-control study of colorectal cancer in young adults in Germany with 800 colorectal cancer cases and 800 non-colorectal cancer control subjects aged 18-49 years.
Health condition or problem studied
- ICD10:
- C18 - Malignant neoplasm of colon
- ICD10:
- C19 - Malignant neoplasm of rectosigmoid junction
- ICD10:
- C20 - Malignant neoplasm of rectum
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Patients with a colorectal cancer diagnosis between 18-49 years of age.
- Arm 2:
- Control persons without a colorectal cancer diagnosis between 18-49 years of age.
Endpoints
- Primary outcome:
- Colorectal cancer diagnosis between 18-49 years of age
- Secondary outcome:
- Prognosis / Survival / Patient-reported outcomes of patients with colorectal cancer between 18-49 years up to 30 years after diagnosis.
Study Design
- Purpose:
- Prevention
- Retrospective/prospective:
- Both
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Darmkrebszentren deutschlandweit
- Other Krebsregister Deutschlandweit
- Other Social Media Plattformen, Unterstützer Internet
Recruitment period and number of participants
- Planned study start date:
- 2022-08-01
- Actual study start date:
- 2022-10-17
- Planned study completion date:
- 2029-12-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1600
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 49 Years
- Additional Inclusion Criteria:
- - First-ever colorectal cancer (ICD-10: C18-20) - Age at diagnosis 18-49 years - Date of diagnosis max. 1 year before - Sufficient knowledge of the German language - Residence in Germany - Healthwise able to participate in a study - Ability to give consent
Exclusion Criteria
Participants who are found not to have met the inclusion criteria after all information is available will be excluded from the study analyses.
Addresses
Primary Sponsor
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Deutsches Krebsforschungszentrum (DKFZ), Abteilung Klinische Epidemiologie und AlternsforschungProf. Dr. Hermann BrennerIm Neuenheimer Feld 58169120 HeidelbergGermany
- Telephone:
- 06221-421300
- Fax:
- 06221-421302
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dkfz.de/de/klinepi
Contact for Public Queries
- Address:
- PEARL-Studienzentrum, Deutsches Krebsforschungszentrum (DKFZ), Abteilung Klinische Epidemiologie und AlternsforschungIm Neuenheimer Feld 58169120 HeidelbergGermany
- Telephone:
- 06221-421320
- Fax:
- 06221-421317
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dkfz.de/de/klinepi
Principal Investigator
- Address:
- Deutsches Krebsforschungszentrum (DKFZ), Abteilung Klinische Epidemiologie und AlternsforschungProf. Dr. Hermann BrennerIm Neuenheimer Feld 58169120 HeidelbergGermany
- Telephone:
- 06221-421300
- Fax:
- 06221-421302
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dkfz.de/de/klinepi
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-04-05
- Ethics committee number:
- S-286/2022
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-07-05
Further identification numbers
- Other primary registry ID:
- ST-D522 - Studybox
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- After an approved data analysis plan has been submitted, data may be transmitted to cooperation partners for anaylsis in exclusively pseudonymized form for the purpose of the designated data analysis. No personal data will be transmitted in the process.
Study protocol and other study documents
- Study protocols:
- Studienprotokoll PEARL
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry