Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

All participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI.

non-contrast liver MRI focusing on HCC surveillance in a short scan time.

Non-contrast focused MRI

Jeong Hee Yoon, MD

In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared

Alternative Surveillance Program for Patients With High Risk Group of HCC

Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC

comparison of incidental findings detected between biannual US and annual focused MRI.

per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.

HCC incidence in the group and detection rate with either US or focused MRI

in room time, table time are manually recorded

comparison between false positive report/finding for HCC in each surveillance modality.

Severance Hospital

The Catholic University of Korea

Korea University Guro Hospital

Seoul National University Hospital

Clinical Professor

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genetic Predisposition to Disease

Disease Susceptibility

Disease Attributes

Ovarian Cancer

Ovarian Epithelial Cancer

Genetic counselling (PRS for risk estimation) and questionnaires in the participating Cancer Genetic Clinics for healthy woman relative of a person first tested in the family (index case) who received a positive genetic test result or a negative non-informative test result

The "Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-BOADICEAV5/PLUS" predicts lifetime and age-specific breast cancer (BC) risks on the basis of family history, all known BC genes test-results, common single nucleotide polymorphisms (SNPs) combined in a PRS, and other non-genetic risk factors. This model is developed within the BRIDGES consortium.

BRIDGES gene panel testing

Breast cancer risk polygenic risk score (PRS)

Self-administered questionnaires for counselees to evaluate Psychosocial Aspects of Hereditary Cancer (PAHC), Breast Cancer risk perception adequacy, risk communication within the family and cancer risk management choice,

Questionnaires

Pierre FUMOLEAU, MD

Study of the psychological impact of breast cancer risk communication in Cancer Genetics based on the personalized estimation of the BOADICEA V5/PLUS model ("Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-version 5 or PLUS").

The new BC gene testing and risk estimation using BOADICEA V5/PLUS model imply an increased complexity of communication during the cancer genetic consultation. It will be proposed to women referred to genetic counselling in the participating Cancer Genetic Clinics .

New qualitative (moderate risks, secondary results) and quantitative results (variation in the degree of cancer risk identified for the counselee and family members) and thus a personalized breast cancer risk may be obtained. How this complexity affects counselees' psychological reactions is not known.

It is primarily aimed at comparing psychosocial needs and distress in healthy women (unaffected with BC) at high risk of breast or ovarian cancer undergoing genetic testing based on an enriched gene panel (index case gene panel plus PRS) at Curie Institute in France and at the University Hospital in Cologne, Germany.

Women referred to genetic counselling in the participating Cancer Genetic Clinics will be included according to the selection criteria.

Breast Cancer Risk After Diagnostic Gene Sequencing

Clinical Application of the European Horizon 2020 Research Project "BRIDGES" - Study of the Psychological Impact of Breast Cancer Risk Communication in Cancer Genetics Based on the Personalized Estimation of the BOADICEA V5/PLUS Model

Breast or ovarian cancer risk perception (the impact of communicating a personalized breast cancer risk using the BOADICEAV5/PLUS model) using a PAHC questionnaire. Questionnaire items are responded on a 4-level scale from 1 (Not at all) to 4 (Very much). Item response scores are averaged and standardized on a 0 to 100 scale, with an increased value indication more severe difficulties.

Counselee's perceived lifetime risks of developing (a first or second) BC will be measured at T2 in words (Not concerned, Don't know, Low risk, Low to moderate risk, Moderate risk, High risk, Very high risk, Major Risk) and in figures (Not concerned, Don't know, 0-10%; between 11-20%, 21-40%, 41-60%, 61-80% and over 80%).

Counselees' choice of cancer risk management will be assessed using a study-specific self-administered questionnaire based on the literature \[Julian-Reynier, 2010\] asking about women's intention or choice to undergo regular mammography, regular breast ultrasound, MRI or preventive mastectomy on a 6-option response scale (Yes, certainly; Yes, probably; I don't know; No, probably not; No, certainly not; Not concerned).

It will be assessed using a study-specific self-administered questionnaire based on the literature \[de Geus, 2015\] asking about women's whether they informed about genetic testing among her husband/partner, children, mother, father, sister(s), brother(s), friend(s) or other family member(s) using a 4, 5 or 5-option response scale depending on the person (Yes, I informed him/her/them; No, but I plan to do it; No (no partner); No; Yes all of them; Yes, some of them; No (children too young); No (no children/brother/sister); No (mother/father deceased).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alternative Surveillance Program for Patients With High Risk Group of HCC	NCT05657249	Hepatocellular ...	Non-contrast fo...	40 Years - 70 Years	Seoul National University Hospital
Alternative Surveillance Program for Patients With High Risk Group of HCC	NCT05657249	Hepatocellular ...	Non-contrast fo...	40 Years - 70 Years	Seoul National University Hospital
Breast Cancer Risk After Diagnostic Gene Sequencing	NCT04145817	Genetic Predisp...	BRIDGES gene pa... Breast cancer r... Questionnaires	18 Years -	Institut Curie

Spots Global Cancer Trial Database for risk estimation