Eligibility
What is the minimum age requirement for all participants
40+
True or false- biomarkers are collected for controls
False. Biomarkers are only collected for cancer cases
How should dates be entered when only the year is known
01-JAN-YYYY
What is the minimum sample collection
2 FULL tubes
Patient W's chart states they are highly suspicious of having esophageal cancer, but an official diagnosis has not been made. Are they eligible for enrollment?
Yes! We can enroll patients as suspected.
Bonus points if you mention something about these suspicious cancer enrollment spots being reserved for priority disease types.
A patient must be enrolled within how many days of their cancer diagnosis?
120
How do you look for biomarkers in a patients chart?
The search feature in epic, or genetrails (solid tumor panel) reports.
When reporting alcohol use the participant tells you they have been sober for 10 years. How would you document this?
Document no for current alcohol use and then enter the frequency of their drinking from when they did drink
What do you do if a blood tube in your kit is damaged or unusable?
If you have not yet collected two full tubes, supplement with tubes from another kit.
All tubes should have labels from their corresponding kit. Place BOTH TRF labels on ONE TRF. All remaining materials and damaged tubes can be discarded.
Patient y is diagnosed with MDS and Esophageal cancer. Are they eligible?
No! MDS is exclusionary unless it has progressed into an index cancer (AML)
Can a participant with a recurrence of cancer diagnosed 3 years ago be enrolled?
No. Recurrences must be 5 years after original diagnosis
What are the three most common biomarkers for breast cancer?
1) ER +/-
2) PR +/-
3) HER 2 +/-
What do you need to do to be able to enter a participants cancer screening information in imedidata?
Switch your profile to eCOA
What days can sample shipments be received by Adela?
Monday-Friday.
Adela can NOT receive shipments on Saturday or Sunday. (do not ship on Friday or Saturday)
Patient x was recently diagnosed with stage 3 prostate cancer. He has had radiation simulation done but has not had radiation treatment done. He received and ADT injection last week. Is he eligible?
No! ADT is considered treatment for prostate cancer.
A patient is currently diagnosed with two primary cancers: lung cancer and esophageal cancer. Which disease type should they be enrolled as?
None! A diagnosis of multiple primary cancers is exclusionary.
Patients pathology demonstrates Wildtype P53 staining does that mean they are
A. Positive for the mutation
B. Negative for the mutation
B. Negative for the mutation
How do you document that you do not know the stage participants cancer?
1. Document in source- stage not available at time of enrollment
2. Document in EDC as ‘unknown’
What is the correct positioning of the label on the blood tubes
So the LOT number and expiration date aren't covered
Patient z was enrolled in the CAMPERR study in 2024 as a control. They were recently diagnosed with a stage 3 thyroid cancer and have not started any treatment. Can they be enrolled into a new cohort for their thyroid cancer?
No! They could only be transferred from the control cohort to the cancer cohort if it was within 120 days of their enrollment date.
Are patients taking tamoxifen for prevention considered on cancer treatment?
MSI is listed as stable in your patients chart. How would you document this
A. Microsatellite instability high
B. Not Microsatellite instability high
B. Not Microsatellite instability high
What are the only disease types you would select "screening" as the method of detection?
Lung, Prostate, Cervical, Colorectal, Breast
Should you list the number of tubes being returned with the kit or the number of tubes containing blood on the TRF?
The number of tubes containing blood should be listed on the TRF under number of tubes collected.
Note: Empty tubes should still be returned with the kit.
Patient R was recently diagnosed with DCIS and is S/P a double mastectomy. Are they eligible for any cohorts?
Yes! Adela does not recognize DCIS as an invasive cancer so this patient would be eligible to enroll as a control.