PEARL

The PEARL study is a so-called case-control study, i.e. we need information from affected colorectal cancer patients on the one hand, but also from unaffected (control) persons from the same age group who do not have colorectal cancer.

Affected cases:

All colorectal cancer patients throughout Germany who have been diagnosed with colorectal cancer between the ages of 18-49 and who were diagnosed no more than 1 year ago can take part in the study.

Control group:

The comparison persons in this study are people from the immediate environment of the patients and are invited to participate in this study via the patients (up to 5 per patient, or even more). These can be, for example, partners, siblings, cousins, friends or work colleagues aged 18-49 who do not have colorectal cancer. Unfortunately, other people who have no connection to a participating colorectal cancer patient cannot take part in this study as a comparison person.

Taking part in this study will not cost you much time, but will make an important contribution to research into ways of preventing colorectal cancer in younger adults. After you have registered with us (ony possible via the German website version), we will send you a study package containing the following materials:

• Cover letter with access data for the online questionnaire
• Participant information, declaration of consent
• Stool sample set, blood sample set
• Return envelopes for free return shipment

We ask you to read through the participant information and, if you agree, to confirm your participation by signing the declaration of consent.

We then ask you to complete the online questionnaire, which you can access here on our website. You will find the required access data in the cover letter that you will receive by post. It can take up to 30 minutes to complete. However, you can interrupt the completion process at any time and continue later.

We also ask you to provide a small stool sample, which you can obtain easily and hygienically using the enclosed stool sample kit. The signed declaration of consent and the stool sample should be returned directly to us in the return envelopes provided (free of charge for you).

Finally, we ask you to have a small blood sample taken with the blood sample kit at your next visit to the doctor, which will then be sent to us. Information with instructions and a billing form is enclosed for the doctor.

If you meet the inclusion criteria for the PEARL study, it is best to request the study materials from us straight away. Simply use the form Request study materials (ony available on the German website version), or give us a call. Once you have received the study materials, you can read through everything at your leisure and then decide whether you would like to take part.

In order to continue to monitor the course of our participants' disease, we will conduct follow-up assessments with the colorectal cancer patients - but not with the control persons - at regular intervals. This is usually done without contacting the participants, e.g. via comparisons with cancer registries and the data centers of the population registry offices. Direct letters are also sent to patients at longer intervals after diagnosis, for example to obtain up-to-date information on the course of the disease and to assess their quality of life.

1. Can I take part in the study if I have not received an invitation?

Colorectal cancer patients who were diagnosed with colorectal cancer between the ages of 18 and 49 and whose diagnosis date was no more than 1 year ago are welcome to contact us and participate without an invitation. Simply send us an e-mail using the contact form or give us a call.

No invitations will be sent out for the recruitment of comparison persons. Comparison subjects in this study are recruited from the environment of the affected colorectal cancer cases, so that you can only participate as a comparison subject if you can be assigned to a participating patient. If this is the case, please contact us via the contact form or by telephone.

2. I cannot log in to the online questionnaire.

If you have problems with the online questionnaire, please contact us via the contact form or use the other contact information listed here and in the cover letter (e-mail, telephone). We will be happy to help you.

3. How will my data be analyzed and protected?

The completed questionnaire will be used for scientific research into colorectal cancer in young adults. The data will be transmitted without personal details only on the basis of a study ID. Your data from the online questionnaire will be stored in a database at the German Cancer Research Center (DKFZ) in Heidelberg. All information from the questionnaire will be stored separately from your address data at the study center.

Only pseudonymized data will be used for evaluation, without your identity being recognized. Pseudonymized means that no details of name, initials or address are available, but only a number and/or letter code is used. It is only possible to assign the data to a specific person with the help of this "key". Whoever evaluates the questionnaire therefore does not know who gave the answers. Once the study has been completed, all personal data is deleted. Subsequent assignment of the data to a specific person is then no longer possible (= anonymization). The provisions of the GDPR-EU and the Federal Data Protection Act are strictly adhered to in this study.

The data protection concept was coordinated with the DKFZ data protection officer and reviewed and positively evaluated by the ethics committee of the Medical Faculty of Heidelberg University.

4. Do I personally benefit from taking part?

Participation in the study is not associated with any direct benefit for the participants. There is no individual feedback to the participants regarding the data collected or the analysis results of the samples received. Your data will be analyzed together with the data of all other participants in the PEARL study. However, your participation is very important in order to improve the possibilities of preventing colorectal cancer in young adults in the future.