Non-invasive Detection of Cancer DNA in Blood and Urine
Johns Hopkins Kimmel Cancer Center in Baltimore
1: Establish the background reference range for cancer specific DNA methylation and structural alterations in urine and plasma from normal individuals.2: Examine cancer-specific DNA methylation and structural alterations in urine and plasma during and after fractionated radiation therapy for men with high-risk prostate cancer.
Inclusion/Exclusion Criteria for Healthy Volunteers as Participants (Arm 1: CLOSED TO ACCRUAL, NO LONGER ENROLLING)Inclusion Criteria:1) Male older than or equal to 18 years of age, but not older than 100 years of age.2) Signed informed consent prior to initiation of any study-related procedures.Exclusion Criteria:1) It is the enrolling study physician’s discretion to decide if a patient is not fit enough to undergo procedures outlined in this protocol.2) Persons who are incarcerated are not eligible to participate.3) Women are not eligible.4) Persons incapable of providing informed consent are not eligible.5) Any person with a personal history of prior malignancy is not eligible6) Persons with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome are not eligible.Inclusion/Exclusion Criteria for Patients as Participants (Arm 2) and (Arm 3: CLOSED TO ACCRUAL, NO LONGER ENROLLING)Inclusion Criteria:1) A histologically confirmed diagnosis of prostate adenocarcinoma which meets NCCN criteria for high-risk disease (T3a-T4 or PSA greater than 20 or Gleason grade greater than 7)2) Male older than or equal to 18 years of age, but not older than 100 years of age.3) Patient’s undergoing definitive radiation therapy and androgen suppression as part of their standard medical care4) Signed informed consent prior to initiation of any study-related procedures.5) Minorities are included in this protocol.Exclusion Criteria:1) It is the enrolling study physician’s discretion to decide if a patient is not fit enough to undergo the procedures outlined in this protocol.2) Patients who are incarcerated are not eligible to participate.3) Women are not eligible to participate4) Patients with a prior history of malignancy or current diagnosis of multiple malignancies are not eligible to participate5) Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome are not eligible.6) Patients incapable of providing informed consent are not eligible.7) Concurrent participation in another therapeutic or interventional clinical trial is not permitted.
Blood CollectionIn most cases, blood samples will be drawn from patients scheduled to have venipuncture for routine clinical purposes. In some cases, when this is not possible, blood draws will occur at times other than those needed for routine clinical care. Generally, blood draws for research purposes will be 4 tablespoons of blood (amounts to 3-4 10mL tubes).Urine CollectionUrine collected from patients is known to contain nucleic acid material that could serve as a biomarker for cancer. In addition, urine studies may involve purification of proteins and/or cells. Urine is self collected fresh in a clean jar and aliquoted into 15 or 50 mL tubes.
01/19/2020 05:03 AM