Breast Cancer Clinical Trial
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
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.
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.
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
Evidence of symptomatic or active cancer requiring active therapeutic intervention at the time of participation. 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.
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