Dataset Information

Positive family history of colorectal cancer in a general practice setting

ABSTRACT: Interventions: Group 1: We want to evaluate the frequency of a family history of colorectal cancer (CRC) and advanced adenomas in 40-54 year old persons in a general practitioner (GP) setting and identify the variables (e.g. demographic, genetic, epigenetic and proteomic biomarkers) that are associated with it. In addition, we want to detect informed decision, anxiety and regret with respect to screening. The health care assistant in the general practice will contact eligible patients and complete the Network against colorectal cancer questionnaire. For those who have a positive family history the GP will provide family members related to CRC patients with adequate evidence-based information and describe prevention strategies. We plan to examine the participant´s family history of CRC in detail and further variables (e.g. demographics) associated with an increased risk will be collected. Additional stool and blood samples will be collected from study-participants who decide to undergo a colonoscopy (n~350) and analyzed in the German Cancer Research Center (DKZF) Heidelberg to see whether further relevant variables are associated with an increased risk of CRC We expect that about 8,750 person in 50 general practices in Hesse will be asked, of those about 875 are expected to have a positive family history of colorectal cancer. Of those, we expect around 350 persons to follow the invitation to have a colonoscopy. Primary outcome(s): Frequency of a family history of (colorectal) cancer and advanced adenomas in a GP setting Study Design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: screening

DISEASE(S): Malignant Neoplasm Of Rectum,Malignant Neoplasm Of Rectosigmoid Junction,Family Risk For Colorectal Cancer (icd-10 Coding: C18, C19, C20),Malignant Neoplasm Of Colon

PROVIDER: 2430726 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Individuals from intervention General Practices who opt in to the study will be given a password, allowing them to access the ‘Family History Website’ tool. This online tool will collect information about their family history of colorectal cancer and encourage discussion with their relatives so that they can gather accurate information. Upon completion of the questionnaire, individuals will be assigned to a NHMRC designated risk category for developing CRC, which will be accompanied by the appropriate screening recommendations, with a personalised summary of their information. This information will be accessible to their GP via a shared access facility, and participants will be encouraged to discuss their results with their GP within the following consultation. The completion of the family history website and GP consultation thereafter, is known as Assessment 1 at time = 0. Participants will be followed up 12 months after their completion of the ‘Family History Website’, where they will be required to self report their five year screening behaviour; while their GP’s will complete a file audit and a survey about the utility of the ‘Family History Website’ tool in addition to their knowledge about CRC risk and screening guidelines. This will be known as assessment 2 at time =1 Primary outcome(s): Outcome Aim: Risk appropriate screening uptake as measured by the participants’ five year screening behaviour in relation to their colorectal cancer risk category Five year screening behaviour- All participants will have their five year screening behaviour recorded at time=1 by self report[12 to 18 months after randomisation, t=1];Colorectal cancer risk category- Intervention practice participants will receive a CRC risk category after completing the ‘Family History Website’ tool., at some time within the 12 month time period t=0. However, participants from control practices will asked about their ‘known family history’ at time=1, and will not be allowed access to the ‘Family History Website’ tool, until after that information is collected.[Within 12 months of the intervention , t=0 for the intervention group and one year after randomisation, t=1 for the control group] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:We obtained peripheral blood samples for women from Utah (USA) and Ontario (Canada) who had a family history of breast cancer (or did not), who carried a BRCA1/2 mutation (or did not), and who had developed breast cancer (or had not). We classified the women into two groups: [1] those who had a family history of breast cancer (irrespective of BRCA1/2 mutation status) and had developed an early-onset breast tumor and [2] those who had a family history of breast cancer but had not developed a breast tumor or who did not have a family history of breast cancer (some of whom had developed sporadic breast cancer and and others who had not). We then used machine-learning methods to assess how well we could classify these women into either group. The Utah samples served as a training set, and the Ontario samples served as an independent validation set from a geographically distinct population. For the Utah cohort, there are 124 samples total: 16 who had a family history of breast cancer and carried a BRCA mutation and had developed breast cancer, 23 with a family history of breast cancer but did not carry a BRCA1/2 mutation and had developed breast cancer, 22 with a family history of breast cancer and carried a BRCA1/2 mutation but had not developed breast cancer, 22 with a family history of breast cancer but did not carry a BRCA1/2 mutation and had not developed breast cancer, 22 with no family history of breast cancer and had developed breast cancer, and 19 with no family history of breast cancer and had not developed breast cancer. The Ontario cohort included 73 samples: 11 who had a family history of breast cancer and carried a BRCA mutation and had developed breast cancer, 17 with a family history of breast cancer but did not carry a BRCA1/2 mutation and had developed breast cancer, 14 with a family history of breast cancer and carried a BRCA1/2 mutation but had not developed breast cancer, 18 with a family history of breast cancer but did not carry a BRCA1/2 mutation and had not developed breast cancer, 8 with no family history of breast cancer and had developed breast cancer, and 5 with no family history of breast cancer and had not developed breast cancer. 36 of the Ontario samples were scanned and processed at Duke University; the remaining 37 samples were handled at Boston University. The batch-adjustment process was repeated twice independently: [1] all 124 Utah samples were adjusted jointly with the 36 Ontario samples that had been processed at Duke University (set 1) and [2] all 124 Utah samples were adjusted jointly with the 37 Ontario samples that had been processed at Boston University (set 2). This dataset represents set 1.

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Positive family history of colorectal cancer in a general practice setting

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