Total Cancer Care: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer
Investigating Cancer through Biological Samples and Data Collection
Anna Maria Storniolo, MD
Primary Investigator
Brief description of study
Detailed description of study
- After enrollment, subjects may have archived tissue collected (research or clinical), fresh tissue collected at the time of planned surgery or biopsy, blood collected (up to 2 tablespoon four times per year with optional consent to 5 tablespoons during two of these draws. The amount of blood to be drawn for pediatric patients will not exceed the lesser of 50 ml or 3 ml/kg in an 8-week period and blood will not be drawn more than two times per week). All samples will be collected during standard of care appointments. Clinical information collected through review of electronic medical records, will be reviewed periodically and participants may be contacted to provide additional information on an annual basis if they agree to being recontacted.
- Surviving next of kin or legal representative may complete enrollment, and then archived tissue will be requested.
- Consent currently outlines possibility of having additional biospecimens collected (e.g. saliva). We have rolled out the collection of urine, buccal cells, blood, tissue, bone marrow, and peritoneal/pleural fluids at this time.
- Patients and their existing biospecimens and data from any protocol noted in the "Release Protocol" in the Notes & Attachments tab may be rolled into Total Cancer Care Protocol (IUSCC-0678) under a waiver of consent/authorization, consistent with the "Release Protocol".
- Tissue from special patient groups (pregnant women, mentally disabled, prisoners, economically or educationally disadvantaged) might be collected, but these groups would not be specifically sought out.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
- 18 years of age and older.
- Has a diagnosis of cancer or is suspected of having cancer.
- Able to understand and sign the Informed Consent form directly.
- Pregnant women are permitted to be enrolled.
This study investigates the collection and storage of biospecimens and personal health information to be used in future research related to cancer. The Total Cancer Care Program aims to gather a unique collection of blood, tissue, and other biological samples, along with associated data from patients who have cancer or are at risk of developing it. This is not a treatment trial, but rather a study designed to create a centralized repository of data and tissue to assist in the prevention, diagnosis, and treatment of cancer.
Participants will have samples collected during their standard care appointments, which may include archived tissue, fresh tissue from planned surgeries or biopsies, and blood samples. Adult participants may have up to 2 tablespoons of blood drawn four times a year, with the possibility of 5 tablespoons during two draws, while pediatric patients will have blood drawn according to specific guidelines. Additional biospecimens such as saliva, urine, buccal cells, bone marrow, and other fluids may also be collected. Clinical information will be reviewed periodically, and participants may be contacted annually for additional information if they consent.
- Who can participate: Individuals 18 years and older who have or are suspected of having cancer are eligible to participate. Participants must be able to understand and sign the Informed Consent form. Pregnant women are allowed to enroll.
- Study details: No payment will be provided for participation, and the study involves the collection of samples such as blood, tissue, and other fluids to build a comprehensive database for cancer research.
