OncoSureTM

Ultra-Fast Detection of All Human Cancers Using Non-Invasive Liquid Biopsy

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For Patients

Do you or any of your loved ones have a diagnosis of or are suspected to have cancer?


Are you undergoing any treatment for cancer?


If you answered YES to any of the questions above, you have an opportunity to help save lives of cancer patients by participating in a clinical study.


You will be compensated for your participation.

120 Minute Rapid Cancer Detection Process

1. Consultation

5 Min.

2. Blood Draw

5 Min.

3. Blood Components Separation

35 Min.

4. Slide Prep + Testing

65 Min.

5. Microscopic
Exam

3 Min.

6. Oncosome Enumoration

1 Min.

7. Oncosome
Profiling

1 Min.

8. Report
Review

5 Min.

Interested? Here’s How It Works

Talk to your doctor to find out if you qualify for the study.

If your doctor decides you qualify and you agree to participate, here is what you can expect:

  • You will be asked to sign an informed consent form.
  • A small amount (about 3cc) of blood will be drawn by a nurse or a phlebotomist.
  • The sample will be sent to a testing laboratory in Orlando with a coded alphanumeric label ONLY since this is a blind study.
  • Your demographic and clinical information will be sent to an independent study coordinator.
  • Generally, the results are available in a couple of days. Since this is a blind study, your doctor will discuss the results with you after the entire study is complete.
  • It is expected that the study will be done by the middle of February 2023.

 

Since this is an investigational study, your doctor will be able to tell you the utility of the results in your clinical care.

But more importantly your participation in the study will undoubtedly help save lives by detecting cancer at an earlier stage for all cancer patients in the future.

Thank you for your help and as a token of appreciation you will receive a $50 Amazon gift card through mail.

Talk to your doctor’s office if you have any questions about the study!
OncoSure Consent Form - English
OncoSure Consent Form - Spanish
OncoSure Patient Brochure
Go to
sign up form

For Physicians

OncoSure Study Protocol
Blood Specimen Collection

Thank you for your valuable time in helping us complete the OncoSureTM clinical blind study.

By now, hopefully you had the chance to watch the video I presented discussing the background of Oncosomes, the results of the Proof-of-concept study and the proposed blind study including the patient inclusion and exclusion criteria.
 
Basically, you can include any cancer patient at any stage of the treatment. If you have the opportunity, try to enroll before the start of the treatment.
 

But if the patient is already receiving the treatment, you can include them:

  • If there was a recent remission within 6 months.
  • If you are suspecting a cancer based on the clinical symptoms.
  • Patients with known history and now in relapse are eligible for participation.
  • ONLY CLL patients are not eligible for participation in the study. All other blood and solid cancer patients are eligible.
  • Please include some normal controls at a ratio of 10:1, 10 patients to one normal.
  • We need 300 cancer patients to finish the study and we need your cooperation to finish the study as soon as possible.
  • For each patient recruited into the study, your practice will get $200. The compensation will be sent to your office right after the completion of the study.
 
If you have any questions, please call Dr. Babu on his cell 321-946-0403 or email rbabu@integenllc.com. Once again, thank you for helping us complete the study.
Relevant Documents
IRB Certificate #1
IRB Certificate #2
IRB Correspondence
Go to sign up form

For Physician's Office

Thank you for helping us finish our clinical study! 

  • Once the doctor decides that a particular patient is eligible for the study, please have the patient sign the written consent form. There are two versions – English and Spanish. Use whichever one is appropriate.
  • Please make sure the witness also signs the consent form.
  • Have the Phlebotomist/Nurse draw 3cc of blood using a purple top EDTA tube.
  • Put ONLY the alphanumeric label on the tube and ship it to the designated address to Orlando, FL.
  • If a bubble wrap is available, you can use it to wrap the sample. Otherwise, it is ok to place the tube (which is plastic) in the mailing envelope.
  • Use FedEx or UPS accounts given to you for shipping. Choose next day, NOT FIRST THING IN THE MORNING.
  • There are two excel spreadsheets – one a simple log and the other a detailed form with clinical information.
  • Complete the form and upload the information to the database which is stored in the cloud. The study coordinator will give you the necessary training to do this before you start enrolling the patients.
  • The spreadsheet is password protected and you will get the password from the study coordinator.
  • You need to provide the patient name and address to the study coordinator, so that the $50 gift card can be mailed to the patients.
  • Contact the study coordinator Harsha Koneru, 256-874-2505, if you have any questions.
Relevant Documents
Blood Drawing Instructions
Patient Consent
Form - Spanish
Patient Consent
Form - English
Study
Excel Sheets
Go to sign up form

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