Clinical Trials- Understand the team and the role

Question 1

Match Criteria, what are they?

Answer 1

1. ) molecular match (somatic and germline biomarkers)
2. ) Diagnosis
3. ) Age
4. ) Current stage of disease
5. ) prior treatments
6. ) medical history
7. ) geographic location

Question 2

T or F, average of 3-5 clinical trials are on the report?

Answer 2

True

Question 3

T or F, will add non-molecular based clinical trials IF unable to find the minimum amount of molecular clinical trials.

Answer 3

True

Question 4

Do we only match to trials in the US?

Answer 4

Yes.

Question 5

Tempus Portal- clinical trial section shows what for the physician?

Answer 5

• the physican can review the clinical trials that were added to the patient’s report.
• The clinical trials will only be available when the report is signed out.

Question 6

T or F, clinical trials normally required some form of stage with the cancer to narrow down the population.

Answer 6

True

Question 7

We need to know prior treatment and medical history for the matching:

Answer 7

Yes

Question 8

It’s super important to get a detailed requision from the physican for clinical trial matching.

Answer 8

True

Question 9

What does NCI-MATCH stand for?

Answer 9

National Cancer Institute- Molecular Analysis for Therapy Choice.

Question 10

What do they do?

Answer 10

it’s a clinical trial that focuses on patients with genetic pathways of interest with agents targeting that specific pathway.

Question 11

Is Tempus a part of this?

Answer 11

Yes, we become a part of this in July 2018

Question 12

How long does the full evalution process take place?

Answer 12

Between 1-10 days (after report is signed out)

Question 13

The process requires a detailed review of inclusion and exclusion variants, T or F?

Answer 13

True

Question 14

Once patient is confirmed as a “potential candidate”, a ____ is sent to the physician and their care team.

Answer 14

referral email/fax

Question 15

T or F, referals are ONLY sent to physicians at NCI-MATCH sites.

Answer 15

True

Question 16

NCI MATCH is NEVER listed on the Tempus sequencing report. T or F?

Answer 16

True

Question 17

What does TAPUR stand for?

Answer 17

Targeted Agent and Profiling Utilization Registry

Question 18

What do they do?

Answer 18

it’s a clinical trial that utilizes commercially available, targeted anticancer drugs to treat patients that have a potentially actionable genomic variant.

Question 19

Clinical trial questions from sales reps and clinicians:

Answer 19

• why wasn’t a trial at a particular institution reported for a patient?
• why was a patient incorrectly matched to a trial?
• what is the order for clinical trials that are listed on the Tempus report?

Question 20

1st question:

Answer 20

• we were not able to verify the institution recruiting.
• molecular trial matching is prioritized first. If not molecular matches are found, the patient will be matched based on patient care diagnosis.

Question 21

2nd:

Answer 21

• lack of clinical information

- unclear trial recruitment status

Question 22

3rd:

Answer 22

• molecular matches are listed first with location in order of closest to furthest from the ordering institution.
• non-molecular matches are listed second.

Question 23

T or F, NCI-Match clinical trial matches appear on the clinical report and in the clinical trials tool in the portal:

Answer 23

False

Question 24

Most mature phase of a clinical trial:

Answer 24

Phase IV

Question 25

Tempus is a commerically-approved lab for which large nationally recognized clinical trials?

Answer 25

• NCI-MATCH

- ASCO-TAPUR