Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Prostatic Neoplasms

Neoplastic Syndromes, Hereditary

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Genetic Diseases, Inborn

Familial Prostate Cancer

The purpose of this study is to identify affected individuals in families with prostate cancer and to use this information to identify genetic markers closely-linked to the disease gene.

National Cancer Institute (NCI)

Digestive System Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Adenoma

Adenomatous Polyposis Coli

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Disease Progression

Duodenal Neoplasms

Polyps

Digestive System Neoplasms

Adenomatous Polyps

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colonic Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Intestinal Polyposis

Duodenal Diseases

Familial Adenomatous Polyposis

MYH-associated Polyposis

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Ursodeoxycholic Acid

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Enzyme Inhibitors

Patients receive oral celecoxib twice daily and oral placebo twice daily

Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily

Celecoxib: 400mg twice daily, orally, 6 months

Ursodeoxycholic acid: orally, 6 months, dosage based on body weight:

below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses

Ursodeoxycholic acid

Placebo: orally, 6 months, dosage based on body weight:

below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses

Placebo

Fokko M Nagengast, MD, Ph D

Bjorn WH van Heumen, MD

Wilbert HM Peters, Ph D

Ellen Kampman, Ph D

Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.

Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)

Dutch Cancer Society

Radboud University Medical Center

Genetic Predisposition to Disease

Disease Susceptibility

Disease Attributes

1. Germline whole-genome family-based sequencing and variant identification.
2. Multidisciplinary Meeting case discussion.
3. Recommendation of referral to a Cancer Genetics Clinic for further investigation, follow up and/or genetic counselling.
4. Psychosocial study to analyse the impact of germline sequencing on families.

Family-based whole genome sequencing

Clinical Trials Manager

Frank Alvaro

Kathy Tucker

Luciano Dalla-Pozza

Assessment of the utility of family-based (trio) whole-genome sequencing for cancer predisposition testing in sequential newly diagnosed paediatric and adolescent cancer patients

Cancer Predisposition Syndromes (CPS), caused by germline mutations in cancer predisposition genes (CPG) are heritable disorders associated with an increased risk of developing certain types of cancer.

Knowledge of CPG will advance the understanding of tumorigenesis, improve patient care, and facilitate genetic counselling of patients and families. But the prevalence of CPS in Australian children with cancer and the psychosocial impact of germline sequencing to identify CPG have not been studied.

The clinical benefit of family-based WGS in every new child with cancer compared with conventional predictive factors is currently unknown. By testing every child with newly diagnosed cancer the aim is to determine the utility of this approach and its impact on participants and families.

The principal objective of the proposed multicentre prospective study is establish the clinical benefit and utility of family-based WGS to identify underlying CPS in every newly diagnosed child with cancer.

Cancer Predisposition Testing by Family-based Whole-genome Sequencing (WGS) in Every Child With Newly Diagnosed Cancer

Assessment of the Utility of Family-based (Trio) Whole-genome Sequencing for Cancer Predisposition Testing in Sequential Newly Diagnosed Paediatric and Adolescent Cancer Patients

This will be achieved through identifying the incidence of patients and parents enrolled in the study experiencing clinically significant levels of distress, defined as a \>7 rating on any of the outcome measures in the Emotion Thermometers Tool©. The incidence of parents and patients experiencing other psychological outcomes such as reduced quality of life will also be identified using the validated scales EuroQoL EQ-5D-5L (parent proxy)/EQ-5D-Y (youth version), Decisional Regret Scale and the Trust In Physician Scale (adapted for a paediatric setting). Psychological outcomes will be re-assessed over the 5 year course of the study to assess impacts of germline sequencing over time.

Children's Cancer Institute Australia

Sydney Children's Hospitals Network

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Familial Prostate Cancer	NCT00001377	Neoplastic Synd... Prostatic Neopl...		-	National Institutes of Health Clinical Center (CC)
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis	NCT00808743	Familial Adenom... Duodenal Neopla... Duodenal Polyps	Celecoxib Ursodeoxycholic... Placebo	18 Years - 70 Years	Radboud University Medical Center
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis	NCT00808743	Familial Adenom... Duodenal Neopla... Duodenal Polyps	Celecoxib Ursodeoxycholic... Placebo	18 Years - 70 Years	Radboud University Medical Center
Cancer Predisposition Testing by Family-based Whole-genome Sequencing (WGS) in Every Child With Newly Diagnosed Cancer	NCT04903782	Neoplastic Synd... Cancer Genetic Predisp...	Family-based wh...	- 21 Years	Sydney Children's Hospitals Network

Spots Global Cancer Trial Database for neoplastic syndromes, hereditary