InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer

Study Overview
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Brief Summary
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This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.

Detailed Description
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The objective of this protocol is to obtain clinical information and facilitate the collection and distribution of specimens obtained during the course of clinical care or research participation. Blood, buccal swabs, urine or tissue or other body fluids (including stool) may be specifically acquired for research in order to perform molecular and other types of analyses for research purposes. These materials will be collected from all eligible participants who have a precursor lesion or an increased risk of cancer It is expected that about 5,000 people will take part in this research study.

Official Title
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InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer

Conditions
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Adenomatous Hyperplasia, Cancer Risk, Cancer Predisposition Syndrome, Hereditary Cancer Prediction, Childhood Cancer Survivors, Adult Cancer Survivors, IARC Carcinogens, Smoking History, Lung Cancer, Ductal/Lobular Carcinoma, Barrett Esophagus, Pancreatic Precursor Lesions, Colonic Dysplasia/Adenomata, Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis, Cirrhosis, High Grade Prostatic Epithelial Neoplasia, High-grade Bladder Urothelial Dysplasia/Carcinoma in Situ, High-risk Oral Precancerous Diseases, Melanocytic Lesion, Adult, Hematologic Malignancy, Lung; Node, Serous Tubal Intraepithelial Carcinoma, Endometrial Intraepithelial Neoplasia, Cervical and Endocervical Carcinoma in Situ, Vulvar Intraepithelial Neoplasia, Nephrogenic Rests, Benign Bone Lesions With Risk of Malignant Degeneration, Giant Cell Tumor, Osteochondroma, Spitz Nevus

Intervention / Treatment
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* Other: Samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type): 1-Hereditary risk for cancer including Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing) Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia) Hereditary Cancer Prediction Model-based elevated cancer risk Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H&N cancer for example), etc. Exposed High Risk including Childhood cancer survivors with treatment exposures associated with increased risk of cancer Adult cancer survivors with treatment exposures associated with increased risk of cancer Documented high level exposure to group 1 IARC carcinogens Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age >50, Smoking history of >15 pack years, First-degree relative history of lung cancer or COPD alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis Precursor Lesions including Breast: ductal/lobular carcinoma in situ (CIS) and atypical hyperplasia GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia/adenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia/carcinoma in situ, Lung: Adenomatous hyperplasia H&N: high-risk oral precancerous diseases Skin: Class II melanocytic lesions. Squamous dysplasia Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas Thoracic: Lung nodules detected on screening CT that prompt further follow-up GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others. FAMILY MEMBERS or healthy individuals Exclusion Criteria: There are no exclusion criteria for the study. Note: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HEREDITARY RISK<br>Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood Buccal swab (saliva) or mouthwash Urine Stool Biopsy or surgical tissue (i.e., bone marrow) Bodily fluids Other tissues | Other: Samples<br>* Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues<br>|
| EXPOSED HIGH RISK<br>Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood Buccal swab (saliva) or mouthwash Urine Stool Biopsy or surgical tissue (i.e., bone marrow) Bodily fluids Other tissues | Other: Samples<br>* Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues<br>|
| PRECURSOR LESIONS<br>Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood Buccal swab (saliva) or mouthwash Urine Stool Biopsy or surgical tissue (i.e., bone marrow) Bodily fluids Other tissues | Other: Samples<br>* Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues<br>|
| FAMILY MEMBERS<br>These family members will be identified by the patients participating in the study. Blood, buccal cells, or saliva or oral rinses will be collected in one of three ways from family members of patients (i) at the time of consent; (ii) via a mailed blood kit or saliva kit; or (iii) at a separate appointment scheduled by the consented participant | Other: Samples<br>* Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. | The InAdvance Study will screen participants for precancerous conditions and cancer through blood tests and tissue biopsies. These biologic samples will be screened for precancerous conditions through routine clinical methods, as well as using novel research level technology. This could include germline testing, whole genome and whole exome sequencing. The participants will be followed serially to track their disease progression. Participants will fill out general health questionnaires, and we will match their answers to the timepoint of their sample submission and follow changes to their answers. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hereditary Risk for Cancer, Childhood cancer survivors, Adult cancer survivors, Precursor Lesions