Current Clinical Trials

Studies listed below are currently open to accept new study patients. If you believe you might meet the baseline criteria, or would simply like more information, please contact us.

Condition Study Name Criteria Additonal Information
Breast Cancer Breast Cancer Screening Study
  • Are between the ages of 40-74 years old
  • Have never been diagnosed with breast cancer or DCIS
  • Have no history of mastectomy in both breasts
  • Get your mammograms in California

Introductory video: https://youtu.be/T7ws9Ewvvis

  • Participation is easy and can be done from home. There are no study visits, doctor’s appointments, or additional lab tests. You don’t need to change health care providers to be part of this study.
  • Study participation may include genetic testing, consultations with a Breast Health Specialist, and risk assessment. There will be no cost to you for these services.
  • The main study lasts for five years and involves answering a health history questionnaire and completing follow-up questionnaires every year.
  • If selected for the personalized screening group, you will be asked to provide a saliva sample, by mail, to look for genetic risk factors for breast cancer.
Cardiovascular Risk High Cardiovascular Risk

Inclusion criteria (partial list)

  • Age: Adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria
  • Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non-high-density lipoprotein cholesterol (non-HDL) ≥ 120 mg/dL (≥ 3.1 mmol/L), or apolipoprotein B ≥ 80 mg/dL (≥ 1.56 µmol/L)
  • Evidence of at least one of the following at screening (without prior myocardial infarction or stroke):
    • A. Significant coronary artery disease (CAD) B. Significant atherosclerotic cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes mellitus

Exclusion criteria (partial list)

  • MI or stroke prior to randomization
  • Coronary artery bypass grafting (CABG) ˂ 3 months prior to screening
  • Planned arterial revascularization
  • Patients will be directed to PCP for normal care/non-study related health concerns
  • Patients will receive study medication at no cost during the course of the study
  • Patients will receive lab tests, physical exams, and study related care at no cost
  • Patients will receive reimbursement of $50 per completed visit for participating
  • The study involves about 14 visits over approximately 4 years 
Colorectal Cancer Screening Evaluation of ctDNA LUNAR Test in an Average Patient Screening Episode
  • Patients are 45-84 years at time of consent
  • Patient is willing and able to undergo a colonoscopy.
  • Patient is considered by a physician or healthcare provider as being of ‘average risk’ for CRC
  • Patient does NOT have a known diagnosis of inflammatory bowel disease
  • Patient has NOT undergone a colonoscopy within preceding 9 years
  • Patient has NOT had a positive FIT/FOBT result within the previous 6 months
  • Patient does NOT have a history of colorectal cancer
  • Patients will be directed to PCP for normal care/non-study related health concerns
  • Patients may receive reimbursement for participating
  • The study consists of patients submitting stool sample through Cologuard kit and completing colonoscopy procedure
  • Time frame for participation is approximately two (2) years
Colorectal Cancer Screening Stool DNA (mt-sDNA 2.0) Test for Colorectal Cancer Screening
  • Patient is genetically male or female, 40 years of age or older.
  • Patient presents for a screening colonoscopy per standard of care.
  • Patient is willing and able to undergo a colonoscopy.
  • Patient does NOT have a diagnosis or personal history of inflammatory bowel disease (IBD)
  • Patient has NOT had a positive Cologuard, or fecal occult blood test or FIT within the previous two (2) years.
  • Patient has NOT undergone a colonoscopy within the previous 9 years.
  • Patient has NOT had overt rectal bleeding within the previous 30 days.
  • Patients will be directed to PCP for normal care/non-study related health concerns
  • Patients may receive reimbursement for participating
  • The study consists of patients submitting stool sample through Cologuard kit and completing colonoscopy procedure
  • Time frame for participation is approximately 60 days
Low Testosterone Low Testosterone with Cardiovascular Disease
  • 45 to 80 years of age (inclusive)
  • Diagnosis of clinical hypogonadism AND presence of at least one of the following: decreased sexual desire/libido, decreased spontaneous erections, decreased energy/fatigue, low/depressed mood, loss of body (axillary and pubic) hair, hot flashes.
  • Have pre-existing CV disease OR at least 3 of the following risk factors: hypertension, dyslipidemia, current smoker, stage 3 chronic kidney disease, diabetes, elevated hsCRP, ≥ 65 years of age.
  • Does NOT have any major surgeries scheduled or planned.
  • Patients may receive reimbursement for participating
  • The study involves about 17 visits and phone contacts every 6 months over approximately 5 years 
Parkinson's Disease Parkinson's Disease (PD) - Online Study
  • Male or female over the age of 18
  • Diagnosis of Parkinson’s disease
  • Has Internet access to provide data online

For more information please visit:  www.foxinsight.org/clinic

  • Surveys on health-related topics to be completed every 3 months for 5 years
  • Optional, one-time surveys and sub-studies including genetic testing and counseling at no cost
  • Appointment reminders and physician reports online for patients
Type 2 Diabetes Type 2 Diabetes

Inclusion criteria (partial list)

  • Male or female, age above or equal to 18 years
  • Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening
  • HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive)
  • Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment
  • regimens:
    • No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a *:
      • *Metformin (≥1500 mg or maximum tolerated or effective dose).
      • * Sulfonylureas (SU) (≥half of the maximum approved dose according to local label or maximum tolerated or effective dose).
      • * SGLT2 inhibitors (maximum tolerated dose).
      • DPP-4 inhibitors (maximally indicated dose as per local label).

Exclusion criteria (partial list)

  • Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
  • Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2
  • Patients will be directed to PCP for normal care/non-study related health concerns
  • Patients will receive study medication at no cost during the course of the study
  • Patients will receive lab tests, physical exams, and study related care at no cost
  • Patients will receive reimbursement of $50 per completed office visit and $20 per completed phone visit for participating
  • The study involves about 15 office visits and 2 phone contacts over approximately 1 year and 4 months 
Type 2 Diabetes or Non-Diabetic Obesity Type 2 Diabetes or Non-Diabetic Obesity

Inclusion criteria (partial list)

  • Male or female participants between the ages of 18 and 75 years, inclusive
    • Type 2 Diabetes
      • Stable (60 days) does of Metformin does of at least 500mg/day
      • HbA1c > 7.0% and < 10.5%
      • BMI > 27 kg/M2
    • Non Diabetics
      • BMI > 30
      • HbA1c < 6.5%

Exclusion criteria (partial list)

  • Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes
  • History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II IV heart failure, or transient ischemic attack within 6 months of screening
  • Participants with a known medical history of active liver disease (other than non alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary biliary cirrhosis
  • Patients will be directed to PCP for normal care/non-study related health concerns
  • Patients will receive study medication at no cost during the course of the study
  • Patients will receive lab tests, physical exams, and study related care at no cost
  • Patients will receive reimbursement of $50 per completed visit and $5 per follow up visit for participating
  • The study involves about 11 visits over approximately 3 months