InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer Risk
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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
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.
Investigators
Sapna Syngal, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
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.
Time Frame: 5 years
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.